CHAPTER 7

List of International International Collaborative Collaborative Research Research Projects Projects ApprovedApproved by by HMSC HMSC during during January, 2008 2008 to to December, December, 2012 2012

S.no. Detail of Projects 1 The relationship between anti- tuberculosis drug absorption and effective antiretroviral therapy in HIV-TB co-infected patients in Bangalore, India

Principal Investigator Funded by Dr. George D'souza Academic Alliance Against AIDS (AAAA), USA Director, St. Johns Medical College, St. Johns Research Institute, St. Johns National Academy of Health Sciences, Date of approval March 2, 2009 Koramangala, Sarjapur Road, Total budget Rs 31, 67,500 Bangalore-560034 Duration 12 Months Subject area HIV/ Tuberculosis

2 Effectiveness of cell phone counseling to improve breast feeding indicators

Principal Investigator Funded by Dr. Archana Patel Alive and Thrive Small Grants Program through Professor, Bill & Melinda Gates Foundation, USA Indira Gandhi Government Medical College, Central Avenue Road, Nagpur-440018 Date of approval June 8, 2010 Total budget Rs 44, 99,002 Duration 18 Months Subject area Reproductive Health

3 Field implementation of the helping babies breathe initiative in Belgaum, Karnataka, India

Principal Investigator Funded by Dr. Shivaprasad S Goudar American Academy of Pediatrics, USA Professor & Head, Jawaharlal Nehru Medical College, JNMC Campus, Nehru Nagar, Belgaum-590010 Date of approval December 8, 2009 Total budget Rs 24, 00,000 Duration 24 Months Subject area Child Health Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

4 Feasibility, acceptability and perceived clinical utility of the cultural formulation interview

Principal Investigator Funded by Dr. Smita N Deshpande American Psychiatric Association, USA Head of Department, Dr. Ram Manohar Lohia Hospital, Baba Kharag Singh Marg, New Delhi-110001 Date of approval December 10, 2012 Total budget Rs 1, 16,600 Duration 6 Months Subject area Mental Health

5 Efficacy and safety of AP 12009 in adult patients with recurrent or refractory anaplastic astrocytoma (WHO grade III) as compared to standard treatment with temozolomide or BCNU: A randomized, actively controlled, open label clinical phase III study (SAPPHIRE)

Principal Investigator Funded by Dr. Ashish Suri Antisense Pharma GmbH, Germany Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2010 Total budget Rs 36, 52,100 Duration 48 Months Subject area Neurosciences

6 Mission Delhi - Delhi emergency life heart - attack initiative saving hearts, saving lives

Principal Investigator Funded by Dr. Balaram Bhargava AUH Hospital, Arhus, Denmark Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012* Total budget Rs 15, 86, 52,728 Duration 36 Months Subject area Cardiovascular Diseases

* Approved with suggestions

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

4 Feasibility, acceptability and perceived clinical utility of the cultural formulation interview 7 Neuro- developmental disabilities among children in India: An INCLEN study

Principal Investigator Funded by Principal Investigator Funded by Dr. Smita N Deshpande American Psychiatric Association, USA Dr. M K C Nair Autism Speaks, USA/ INCLEN Inc., USA and National Trust and Ministry of Social Justice and Head of Department, Professor & Director, Empowerment, India Dr. Ram Manohar Lohia Hospital, Child Development Centre, Baba Kharag Singh Marg, Medical College, New Delhi-110001 Thiruvananthapuram-695011 Date of approval December 10, 2012 Date of approval September 8, 2009* Total budget Rs 1, 16,600 Total budget Rs 2, 07, 16, 264 Duration 6 Months Duration 24 Months Subject area Mental Health Subject area Child Health

5 Efficacy and safety of AP 12009 in adult patients with recurrent or refractory anaplastic astrocytoma (WHO grade III) as compared to standard treatment with temozolomide or BCNU: A 8 PASS: Parent-mediated intervention for Autism Spectrum Disorders (ASD) in South Asia randomized, actively controlled, open label clinical phase III study (SAPPHIRE)

Principal Investigator Funded by Principal Investigator Funded by Dr. Ashish Suri Antisense Pharma GmbH, Germany Dr. Vikram Patel Autism Speaks, USA Associate Professor, Professor, All India Institute of Medical Sciences Sangath Centre, (AIIMS), Ansari Nagar, 841/1 Alto Porvorim, New Delhi-110029 Goa-403521 Date of approval March 8, 2010 Date of approval September 10, 2012 * Total budget Rs 36, 52,100 Total budget Rs 53, 11,530 Duration 48 Months Duration 24 Months Subject area Neurosciences Subject area Mental Health

6 Mission Delhi - Delhi emergency life heart - attack initiative saving hearts, saving lives 9 The epidemiology and transmission of Tuberculosis (TB) among household contacts in Southern India with a focus on risk factors

Principal Investigator Funded by Principal Investigator Funded by Dr. Balaram Bhargava AUH Hospital, Arhus, Denmark Dr. K R John Australian Research Council (ARC), Australia Professor, Professor, All India Institute of Medical Sciences Christian Medical College & Hospital, (AIIMS), Ansari Nagar, Ida Scudder Road, New Delhi-110029 Vellore-632004 Date of approval March 12, 2012* Date of approval June 8, 2010 Total budget Rs 15, 86, 52,728 Total budget Rs 16, 80, 000 Duration 36 Months Duration 12 Months Subject area Cardiovascular Diseases Subject area Tuberculosis

* Approved with suggestions * Approved with conditions

Indian Council of Medical Research 31

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

10 The development and evaluation of m-Health service in the control of Tuberculosis (TB) in India

Principal Investigator Funded by Dr. Dilip Mathai Australian Research Council (ARC), Australia; University of Melbourne, Australia and Bill & Head, Melinda Gates Foundation, USA Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval December 8, 2011 Total budget Rs 54, 85, 500 Duration 36 Months Subject area Tuberculosis

11 A phase III trial of adjuvant chemotherapy following chemo-radiation as primary treatment for locally advanced cervical cancer compared to chemo-radiation alone: The OUTBACK TRIAL

Principal Investigator Funded by Dr. S K Shrivastava Australia and New Zealand Gynecological Oncology Group (ANZGOG), Australia Professor & Head, Tata Memorial Hospital, Tata Memorial Centre, Parel, Mumbai-400012 Date of approval December 10, 2012 Total budget Rs 74, 92,000 Duration 36 Months Subject area Oncology

12 The Rishi Valley Vascular Disease Project - An observational and interventional public health project in vascular health in a typical rural South Indian community

Principal Investigator Funded by Dr. Kartik Kalyanram Baker H eart Research Institute, Australia Coordinator, Rishi Valley Rural Health Centre, Rishi Valley PO, Madanapalle, Chittor-517352 Date of approval June 8, 2009* Total budget Rs 1, 50, 74,400 Duration 144 Months Subject area Cardiovascular Diseases

* Approved with suggestions Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

10 The development and evaluation of m-Health service in the control of Tuberculosis (TB) in India 13 Novel molecular mechanisms leading to HAEMOPHILIA A phenotype

Principal Investigator Funded by Principal Investigator Funded by Dr. Dilip Mathai Australian Research Council (ARC), Australia; Dr. Alok Srivastava Bayer Haemophilia Award, United Kingdom University of Melbourne, Australia and Bill & Head, Melinda Gates Foundation, USA Professor & Head, Christian Medical College & Hospital, Christian Medical College & Hospital, Ida Scudder Road, Ida Scudder Road, Vellore-632004 Vellore- 632004 Date of approval December 8, 2011 Date of approval June 8, 2009 Total budget Rs 54, 85, 500 Total budget Rs 18, 80,000 Duration 36 Months Duration 24 Months Subject area Tuberculosis Subject area Haematology

11 A phase III trial of adjuvant chemotherapy following chemo-radiation as primary treatment for 14 Development and validation of sampling strategies for stopping / continuing Programmes to locally advanced cervical cancer compared to chemo-radiation alone: The OUTBACK TRIAL Eliminate Lymphatic Filariasis (PELF)

Principal Investigator Funded by Principal Investigator Funded by Dr. S K Shrivastava Australia and New Zealand Gynecological Dr. S Subramanian Bill & Melinda Gates Foundation, USA Oncology Group (ANZGOG), Australia Professor & Head, Scientist D, Tata Memorial Hospital, Vector Control Research Centre (VCRC), Tata Memorial Centre, Parel, Medical Complex, Indira Nagar, Mumbai-400012 Puducherry-605006 Date of approval December 10, 2012 Date of approval March 25, 2008 Total budget Rs 74, 92,000 Total budget Rs 75, 45,178 Duration 36 Months Duration 15 Months Subject area Oncology Subject area Filariasis

12 The Rishi Valley Vascular Disease Project - An observational and interventional public health 15 Global HIV / AIDS Vaccine Enterprises (GHAVE), Comprehensive Antibody Vaccine Immune project in vascular health in a typical rural South Indian community Monitoring Consortium (GCAV)

Principal Investigator Funded by Principal Investigator Funded by Dr. Kartik Kalyanram Baker H eart Research Institute, Australia Dr. Ramesh S Paranjape Bill & Melinda Gates Foundation, USA Coordinator, Scientist G & Director, Rishi Valley Rural Health Centre, National AIDS Research Institute (NARI), Rishi Valley PO, Madanapalle, 73 G Block, MIDC, Chittor-517352 Bhosari, Post Box No. 1875, Date of approval June 8, 2009* Date of approval March 25, 2008 Pune-411026 Total budget Rs 1, 50, 74,400 Total budget Rs 1, 67, 45,710 Duration 144 Months Duration 60 Months Subject area Cardiovascular Diseases Subject area HIV/AIDS/ STD

* Approved with suggestions

Indian Council of Medical Research 33

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

16 Assessment of the added impact of vector control for augmentation of MDA to eliminate Lymphatic Filariasis (LF) in South India

Principal Investigator Funded by Dr. I P Sunish Bill & Melinda Gates Foundation, USA Scientist C, Centre for Research in Medical Entomology (CRME), 4 Sarojani Street, Chinna Chokkikulam, Date of approval June 23, 2008 Madurai-625002 Total budget Rs 1, 04, 40,000 Duration 48 Months Subject area Filariasis

17 Effect of albendazole dose and interval on Wucheria bancrofti microfilarial clearance in India; a randomized, open label study

Principal Investigator Funded by Dr. Shantanu K Kar Bill & Melinda Gates Foundation, USA Scientist G & Director, Regional Medical Research Centre (RMRC), Chandrasekharpur, Bhubaneswar-751023 Date of approval June 23, 2008 Total budget Rs 48, 41,200 Duration 36 Months Subject area Filariasis

18 Diagnostic tool assessment to measure the impact of Mass Drug Administration (MDA) on W.bancrofti infection and transmission: Multi-country evaluation

Principal Investigator Funded by Dr. R L J De Britto Bill & Melinda Gates Foundation, USA Scientist E, Vector Control Research Centre (VCRC), Medical Complex, Indira Nagar, Date of approval June 23, 2008 Puducherry-605006 Total budget Rs 18, 80,760 Duration 12 Months Subject area Filariasis

35

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

16 Assessment of the added impact of vector control for augmentation of MDA to eliminate 19 A study of sub clinical lymphatic manifestation in W.bancrofti infection Lymphatic Filariasis (LF) in South India

Principal Investigator Funded by Principal Investigator Funded by Dr. I P Sunish Bill & Melinda Gates Foundation, USA Dr. Shantanu K Kar Bill & Melinda Gates Foundation, USA Scientist C, Scientist G & Director, Centre for Research in Medical Entomology Regional Medical Research Centre (CRME), (RMRC), Chandrasekharpur, 4 Sarojani Street, Chinna Chokkikulam, Bhubaneswar-751023 Date of approval June 23, 2008 September 8, 2009 Madurai-625002 Date of approval Total budget Rs 1, 04, 40,000 Total budget Rs 66, 83,257 Duration 48 Months Duration 36 Months Subject area Filariasis Subject area Filariasis

17 Effect of albendazole dose and interval on Wucheria bancrofti microfilarial clearance in India; a 20 Planning for the delivery of a more effective oral rehydration solution to improve diarrhea control randomized, open label study worldwide

Principal Investigator Funded by Principal Investigator Funded by Dr. Shantanu K Kar Bill & Melinda Gates Foundation, USA Dr. B S Ramakrishna Bill & Melinda Gates Foundation, USA Scientist G & Director, Professor, Regional Medical Research Centre Christian Medical College & Hospital, (RMRC), Chandrasekharpur, Ida Scudder Road, Bhubaneswar-751023 Vellore-632004 Date of approval June 23, 2008 Date of approval December 8, 2009 Total budget Rs 48, 41,200 Total budget Rs 1, 67, 00,000 Duration 36 Months Duration 24 Months Subject area Filariasis Subject area Diarrhoeal Diseases

18 Diagnostic tool assessment to measure the impact of Mass Drug Administration (MDA) on 21 Development and validation of sampling strategies for xenomonitoring of infection in Culex W.bancrofti infection and transmission: Multi-country evaluation vector by PCR as a surveillance tool for assessing post-MDA situation of Lymphatic Filariasis elimination programme Principal Investigator Funded by Principal Investigator Funded by Dr. R L J De Britto Bill & Melinda Gates Foundation, USA Dr. S Subramanian Bill & Melinda Gates Foundation, USA Scientist E, Scientist D, Vector Control Research Centre Vector Control Research Centre (VCRC), (VCRC), Medical Complex, Medical Complex, Indira Nagar, Indira Nagar, Date of approval June 23, 2008 Date of approval March 8, 2010 Puducherry-605006 Puducherry-605006 Total budget Rs 18, 80,760 Total budget Rs 66, 44,402 Duration 12 Months Duration 36 Months Subject area Filariasis Subject area Filariasis

Indian Council of Medical Research 35

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

22 Study to evaluate the impact of topical application of improved oil and/or improved skin care practices on neonatal mortality: A community based cluster randomized controlled trail in rural India Principal Investigator Funded by Dr. Vishwajeet Kumar Bill & Melinda Gates Foundation, USA Principal Investigator, Saksham/INCLEAN Trust, 1, Shahmina Road Chhatrapati Shahuji Maharaja Medical Date of approval March 8, 2010 * University, Chowk, Lucknow-226003 Total budget Rs 44, 93, 98,710 Duration 54 Months Subject area Child Health

23 Comprehensive investigation into the risk factors of malnutrition and the consequences for child health

Principal Investigator Funded by Dr. Gagandeep Kang Bill & Melinda Gates Foundation, USA Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval March 8, 2010 Total budget Rs 9, 77, 80,150 Duration 60 Months Subject area Nutrition

24 Measurement, Learning and Evaluation (MLE) of the urban reproductive health initiative in India

Principal Investigator Funded by Dr. Ravi K Verma Bill & Melinda Gates Foundation, USA Regional Director, International Center for Research on Women (ICRW), Asia Regional Office, C – 139, Defence Colony, Date of approval March 8, 2010 New Delhi-110024 Total budget Rs 9, 43, 69,950 Duration 60 Months Subject area Reproductive Health

* Approved with conditions

37

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

22 Study to evaluate the impact of topical application of improved oil and/or improved skin care 25 Post-MDA surveillance of rural communities in South India practices on neonatal mortality: A community based cluster randomized controlled trail in rural India Principal Investigator Funded by Principal Investigator Funded by Dr. Vishwajeet Kumar Bill & Melinda Gates Foundation, USA Dr. P Vanamail Bill & Melinda Gates Foundation, USA Principal Investigator, Technical Officer, Saksham/INCLEAN Trust, Vector Control Research Centre 1, Shahmina Road (VCRC), Medical Complex, Indira Chhatrapati Shahuji Maharaja Medical Nagar, Date of approval March 8, 2010 * Date of approval March 8, 2011 University, Chowk, Puducherry-605006 Lucknow-226003 Total budget Rs 44, 93, 98,710 Total budget Rs 11, 54, 800 Duration 54 Months Duration 36 Months Subject area Child Health Subject area Filariasis

23 Comprehensive investigation into the risk factors of malnutrition and the consequences for child 26 Two community strategies comparing use of misoprostol for early treatment / secondary health prevention to primary prevention for postpartum hemorrhage: A randomized cluster non- inferiority study in Bijapur district, Karnataka

Principal Investigator Funded by Principal Investigator Funded by Dr. Gagandeep Kang Bill & Melinda Gates Foundation, USA Dr. Shivaprasad S Goudar Bill & Melinda Gates Foundation, USA Professor, Professor & Head, Christian Medical College & Hospital, Jawaharlal Nehru Medical College, Ida Scudder Road, JNMC Campus, Nehru Nagar, Vellore-632004 Belgaum-590010 Date of approval March 8, 2010 Date of approval June 8, 2011 Total budget Rs 9, 77, 80,150 Total budget Rs 96, 23, 413 Duration 60 Months Duration 24 Months Subject area Nutrition Subject area Reproductive Health

24 Measurement, Learning and Evaluation (MLE) of the urban reproductive health initiative in India 27 Bihar Evaluation of Social franchising and Telemedicine (BEST)

Principal Investigator Funded by Principal Investigator Funded by Dr. Ravi K Verma Bill & Melinda Gates Foundation, USA Dr. Manish Kakkar Bill & Melinda Gates Foundation, USA Regional Director, Specialist & Epidemiologist, International Center for Research on Public Health Foundation of India, ISID Women (ICRW), Asia Regional Office, Campus 4, Institutional Area, Vasant Kunj, C – 139, Defence Colony, New Delhi-110070 Date of approval March 8, 2010 Date of approval March 12, 2012 New Delhi-110024 Total budget Rs 9, 43, 69,950 Total budget Rs 62, 94,320 Duration 60 Months Duration 48 Months Subject area Reproductive Health Subject area Health Systems Research

* Approved with conditions

Indian Council of Medical Research 37 38

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

28 Evaluation of the Bihar family health initiative

Principal Investigator Funded by Dr. Lalit Dandona Bill & Melinda Gates Foundation, USA Professor, Public Health Foundation of India, 4/2, Sirifort Institutional Area, August Kranti Marg, Date of approval June 18, 2012 New Delhi-110016 Total budget Rs 16, 77, 07,000 Duration 60 Months Subject area Health Systems Research

29 The costs of care and constraints to equitable service provision in the ART progrmme in the states of Andhra Pradesh and Rajasthan

Principal Investigator Funded by Dr. Lalit Dandona Bill & Melinda Gates Foundation, USA Professor, Public Health Foundation of India, 4/2, Sirifort Institutional Area, August Kranti Marg, Date of approval June 18, 2012 New Delhi-110016 Total budget Rs 50, 00,000 Duration 24 Months Subject area HIV/AIDS/ STD

30 Evaluating - shaping demand and practices to improve family health in Bihar

Principal Investigator Funded by Dr.Vishal D Shastri Bill & Melinda Gates Foundation, USA Head of Research, BBC World Service Trust India, E-21, Hauz Khas Market, New Delhi-110016 Date of approval September 10, 2012 Total budget Rs 2, 08, 32, 900 Duration 60 Months Subject area Health Systems Research

39

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

28 Evaluation of the Bihar family health initiative 31 Epidemiology of visceral leishmaniasis in Bihar

Principal Investigator Funded by Principal Investigator Funded by Dr. Lalit Dandona Bill & Melinda Gates Foundation, USA Dr. Shyam Sundar Bill & Melinda Gates Foundation, USA Professor, Professor, Public Health Foundation of India, Institute of Medical Sciences, 4/2, Sirifort Institutional Area, Banaras Hindu University, August Kranti Marg, Varanasi-221005 Date of approval June 18, 2012 Date of approval December 10, 2012 New Delhi-110016 Total budget Rs 16, 77, 07,000 Total budget Rs 7, 66, 92,650 Duration 60 Months Duration 36 Months Subject area Health Systems Research Subject area Leishmaniasis

29 The costs of care and constraints to equitable service provision in the ART progrmme in the states 32 Pilot introduction of the modified bivalent killed whole cell oral cholera vaccine in Orissa of Andhra Pradesh and Rajasthan

Principal Investigator Funded by Principal Investigator Funded by Dr. Lalit Dandona Bill & Melinda Gates Foundation, USA Dr. Shantanu K Kar Bill and Melinda Gates Foundation & The International AIDS Vaccine Institute, Korea Professor, Scientist G & Director, Public Health Foundation of India, Regional Medical Research Centre 4/2, Sirifort Institutional Area, (RMRC), Chandrasekharpur, August Kranti Marg, Bhubaneswar-751023 Date of approval June 18, 2012 Date of approval September 8, 2010 New Delhi-110016 Total budget Rs 50, 00,000 Total budget Rs 59, 39,520 Duration 24 Months Duration 10 Months Subject area HIV/AIDS/ STD Subject area Diarrhoeal Diseases

30 Evaluating - shaping demand and practices to improve family health in Bihar 33 Assessing the effectiveness, safety and feasibility of expanding use of oxytocin in UnijectTM by auxiliary nurse midwives to prevent postpartum hemorrhage: A community based cluster randomized trial in Bagalkot, India

Principal Investigator Funded by Principal Investigator Funded by Dr.Vishal D Shastri Bill & Melinda Gates Foundation, USA Dr. Shivaprasad S Goudar Bill and Melinda Gates Foundation, USA & Program for Appropriate Technology in Health Head of Research, Professor & Head, (PATH), USA BBC World Service Trust India, Jawaharlal Nehru Medical College, E-21, Hauz Khas Market, JNMC Campus, Nehru Nagar, New Delhi-110016 Belgaum-590010 Date of approval September 10, 2012 Date of approval June 8, 2010 * Total budget Rs 2, 08, 32, 900 Total budget Rs 2, 60, 04,688 Duration 60 Months Duration 36 Months Subject area Health Systems Research Subject area Reproductive Health

* Revised protocol approved by Chairman and endorsed in HMSC meeting held on March 8, 2011

Indian Council of Medical Research 39

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

34 The Oxytocin Initiative: Exploring use of uterotonic substances at or around birth in two states in India

Principal Investigator Funded by Dr. Nitya Nand Deepak Bill & Melinda Gates Foundation, USA (Through Program for Appropriate Technology in Health, Research Coordinator, USA) Programme for Appropriate Technology in Health (PATH), A-9, Qutab Institutional Area, Date of approval December 8, 2010 New Delhi-110067 Total budget Rs 32, 09,730 Duration 18 Months Subject area Reproductive Health

35 A multicentre, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of PEFylated interferon beta-la (BIIBO-17) in subjects with relapsing multiple sclerosis

Principal Investigator Funded by Dr. Manjari Tripathi Biogen Idec Limited, United Kingdom Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi- 110029 Date of approval March 8, 2010* Total budget Rs 18, 29, 823 Duration 42 Months Subject area Neurosciences

An open - label, multicenter evaluation of the safety, pharmacokinetics, and efficacy of 36 recombinant, long- acting coagulation factor IX Fc fusion (rFIXFc) in the prevention and treatment of bleeding in previously treated subjects with severe hemophilia B

Principal Investigator Funded by Dr. Renu Saxena Biogen Idec Limited, United Kingdom Professor and Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010 Total budget Rs 8, 92,224 Duration 12 Months Subject area Haematology

* Approved for AIIMS, New Delhi only with conditions

41

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

34 The Oxytocin Initiative: Exploring use of uterotonic substances at or around birth in two states in 37 A dose-blind, multicenter, extension study to determine the long- term safety and efficacy of two India doses of BG00012 monotherapy in subjects with relapsing-remitting multiple sclerosis

Principal Investigator Funded by Principal Investigator Funded by Dr. Nitya Nand Deepak Bill & Melinda Gates Foundation, USA (Through Dr. Madhuri Behari Biogen Idec Limited, United Kingdom Program for Appropriate Technology in Health, Research Coordinator, Professor, USA) Programme for Appropriate Technology in All India Institute of Medical Sciences Health (PATH), (AIIMS), Ansari Nagar, A-9, Qutab Institutional Area, New Delhi-110029 Date of approval December 8, 2010 Date of approval December 8, 2010 * New Delhi-110067 Total budget Rs 32, 09,730 Total budget Rs 18, 48,420 Duration 18 Months Duration 24 Months Subject area Reproductive Health Subject area Neurosciences

38 A phase III multi-centre, randomized parallel group study of safety and efficacy of the LB03002 a 35 A multicentre, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the new sustained release formulation of human recombinant growth harmone as compared to efficacy and safety of PEFylated interferon beta-la (BIIBO-17) in subjects with relapsing multiple standard daily therapy with Genotropin in treatment naive children with growth failure due to sclerosis insufficient secretion of endogenous growth hormone Principal Investigator Funded by Principal Investigator Funded by Dr. Manjari Tripathi Biogen Idec Limited, United Kingdom Dr. Rajesh Khadgawat Biopartners GmbH, Switzerland Associate Professor, Associate Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi- 110029 New Delhi-110029 Date of approval March 8, 2010* Date of approval June 8, 2010 ** Total budget Rs 18, 29, 823 Total budget Rs 27,888 Duration 42 Months Duration 24 Months Subject area Neurosciences Subject area Child Health

An open - label, multicenter evaluation of the safety, pharmacokinetics, and efficacy of 36 39 Risk factors, treatments and outcomes for emergency department patients with atrial fibrillation in recombinant, long- acting coagulation factor IX Fc fusion (rFIXFc) in the prevention and multiple regions of the world treatment of bleeding in previously treated subjects with severe hemophilia B

Principal Investigator Funded by Principal Investigator Funded by Dr. Renu Saxena Biogen Idec Limited, United Kingdom Dr. Prem Pais Boehringer Ingelhein, Germany Professor and Head, Dean & Professor, All India Institute of Medical Sciences St. Johns Medical College, St. Johns (AIIMS), Ansari Nagar, Research Institute, New Delhi-110029 St. Johns National Academy of Health Date of approval December 8, 2010 Date of approval December 22, 2008 Sciences, Total budget Rs 8, 92,224 Koramangala, Sarjapur Road, Total budget Rs 73, 61,250 Bangalore-560034 Duration 12 Months Duration 24 Months Subject area Haematology Subject area Cardiovascular Diseases

* Approved for AIIMS, New Delhi only with conditions * Approved for AIIMS, New Delhi only ** Approved with conditions

Indian Council of Medical Research 41 Indian Council of Medical Research 42

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

40 A randomized, double-blind, multi- center phase-III study of Brivanib plus Best Supportive Care (BSC) versus placebo plus BSC in subjects with advanced Hepatocullular Carcinoma (HCC) who have failed or are intolerant to forafenib: The BRISK PS Study

Principal Investigator Funded by Dr. Yogesh K Chawla Bristol Myers Squibb India Pvt. Ltd. Professor & Head, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval December 8, 2010 Chandigarh-160012 Total budget Rs 3, 08,520 Duration 24 Months Subject area Oncology

41 A randomized, double-blind, multi-center phase-III study of brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (The BRISK FL Study)

Principal Investigator Funded by Dr. Yogesh K Chawla Bristol Myers Squibb India Pvt. Ltd. Professor and Head, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval December 8, 2010 Chandigarh-160012 Total budget Rs 11, 03,920 Duration 24 Months Subject area Oncology

42 Study to evaluate the effect of physician's advice in quitting smoking in HIV and TB patients in South India - A pilot study

Principal Investigator Funded by Dr. S Ramesh Kumar Brown University, USA Scientist B, Tuberculosis Research Centre (TRC), Madurai Unit, Madurai-625107 Date of approval March 2, 2009 Total budget Rs 5, 70,000 Duration 24 Months Subject area HIV/ Tuberculosis

Research Projects Approved by HMSC ResearchResearch Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

40 A randomized, double-blind, multi- center phase-III study of Brivanib plus Best Supportive Care 43 CABG Off or On Pump Revascularization Study (CORONARY) (BSC) versus placebo plus BSC in subjects with advanced Hepatocullular Carcinoma (HCC) who have failed or are intolerant to forafenib: The BRISK PS Study

Principal Investigator Funded by Principal Investigator Funded by Dr. Yogesh K Chawla Bristol Myers Squibb India Pvt. Ltd. Dr. D Prabhakaran Canadian Institutes of Health Research (CIHR), Canada Professor & Head, Executive Director, Post Graduate Institute of Medical Center for Chronic Disease Control Education and Research (PGIMER), (CCDC), C1/52, Second Floor, Sector 12-D, Safdarjung Development Area, Date of approval December 8, 2010 Date of approval December 22, 2008 * Chandigarh-160012 New Delhi-110016 Total budget Rs 3, 08,520 Total budget Rs 1, 46, 85,375 Duration 24 Months Duration 90 Months Subject area Oncology Subject area Cardiovascular Diseases

Prevalence and incidence of tuberculosis infection among nursing students in a South Indian 41 A randomized, double-blind, multi-center phase-III study of brivanib versus sorafenib as first-line 44 treatment in patients with advanced hepatocellular carcinoma (The BRISK FL Study) teaching hospital, as assessed by Quanti FERON-TB-Gold interferon-gamma assay (QFT) and Tuberculin Skin Test (TST)

Principal Investigator Funded by Principal Investigator Funded by Dr. Yogesh K Chawla Bristol Myers Squibb India Pvt. Ltd. Dr. D J Christopher Canadian Institutes of Health Research (CIHR), Canada Professor and Head, Professor & Head, Post Graduate Institute of Medical Christian Medical College & Hospital, Education and Research (PGIMER), Ida Scudder Road, Sector 12-D, Vellore- 632004 Date of approval December 8, 2010 Date of approval December 22, 2008 Chandigarh-160012 Total budget Rs 11, 03,920 Total budget Rs 7, 90,000 Duration 24 Months Duration 12 Months Subject area Oncology Subject area Tuberculosis

42 Study to evaluate the effect of physician's advice in quitting smoking in HIV and TB patients in 45 Use of indicator amino acid oxidation to determine amino acid requirements South India - A pilot study

Principal Investigator Funded by Principal Investigator Funded by Dr. S Ramesh Kumar Brown University, USA Dr. Anura Kurpad Canadian Institutes of Health Research (CIHR), Canada Scientist B, Professor, Tuberculosis Research Centre (TRC), St. Johns Medical College, St. Johns Madurai Unit, Research Institute, St. Johns National Academy of Health Madurai-625107 Date of approval March 2, 2009 Date of approval March 2, 2009 Sciences, Total budget Rs 5, 70,000 Koramangala, Sarjapur Road, Total budget Rs 14, 77,410 Bangalore-560034 Duration 24 Months Duration 60 Months Subject area HIV/ Tuberculosis Subject area Nutrition

* Formal approval of project and inclusion / drop of study site was endorsed in HMSC meeting held on June 8, 2010

Indian Council of Medical Research 43 44

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

46 The influence of maternal vitamin A level on fetal kidney development

Principal Investigator Funded by Dr. K D Phadke Canadian Institutes of Health Research (CIHR), Canada Associate Professor, St. Johns Medical College and Institute of Population Health and Clinical Research (IPHCR), Date of approval March 2, 2009 St. Johns National Academy of Health Sciences, Total budget Rs 30, 75,000 Bangalore-560034 Duration 36 Months Subject area Nutrition

47 Genetic dissection of leprosy susceptibility

Principal Investigator Funded by Prof. Narinder K Mehra Canadian Institutes of Health Research (CIHR), Canada Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval June 8, 2009 Total budget Rs 17, 87,400 Duration 36 Months Subject area Leprosy

48 Coronary CT angiography to predict vascular events in non-cardiac surgery patients cohort evaluation (CTA VISION) study

Principal Investigator Funded by Dr. G Karthikeyan Canadian Institutes of Health Research (CIHR), Canada Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010 Total budget Rs 19, 19, 590 Duration 36 Months Subject area Cardiovascular Diseases

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Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

46 The influence of maternal vitamin A level on fetal kidney development 49 Global registry of rheumatic heart disease

Principal Investigator Funded by Principal Investigator Funded by Dr. K D Phadke Canadian Institutes of Health Research (CIHR), Dr. G Karthikeyan Canadian Institutes of Health Research (CIHR), Canada Canada Associate Professor, Associate Professor, St. Johns Medical College and Institute All India Institute of Medical Sciences of Population Health and Clinical (AIIMS), Ansari Nagar, Research (IPHCR), New Delhi-110029 Date of approval March 2, 2009 Date of approval December 8, 2010 * St. Johns National Academy of Health * Sciences, Total budget Rs 30, 75,000 Total budget Rs 9, 73,248 Bangalore-560034 Duration 36 Months Duration 30 Months Subject area Nutrition Subject area Cardiovascular Diseases

47 Genetic dissection of leprosy susceptibility 50 Steroids in cardiac surgery (SIRS) trial

Principal Investigator Funded by Principal Investigator Funded by Prof. Narinder K Mehra Canadian Institutes of Health Research (CIHR), Dr. G Karthikeyan Canadian Institutes of Health Research (CIHR), Canada Canada Professor & Head, Associate Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval June 8, 2009 Date of approval March 8, 2011 ** Total budget Rs 17, 87,400 Total budget Rs 78, 42,035 Duration 36 Months Duration 24 Months Subject area Leprosy Subject area Cardiovascular Diseases

48 Coronary CT angiography to predict vascular events in non-cardiac surgery patients cohort 51 The remote Ischemic preconditioning in cardiac surgery trial pilot (Remote IMPACT pilot) evaluation (CTA VISION) study

Principal Investigator Funded by Principal Investigator Funded by Dr. G Karthikeyan Canadian Institutes of Health Research (CIHR), Dr. G Karthikeyan Canadian Institutes of Health Research (CIHR), Canada Canada Associate Professor, Associate Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi- 110029 Date of approval December 8, 2010 Date of approval September 8, 2011 *** Total budget Rs 19, 19, 590 Total budget Rs 67,923 Duration 36 Months Duration 12 Months Subject area Cardiovascular Diseases Subject area Cardiovascular Diseases

* Inclusion of one more study site endorsed in HMSC meeting held on December 8, 2011 ** Approved and endorsed for 5 additional centers in HMSC meetings held on September 8, 2011 and March 12, 2012 *** Approved with conditions

Indian Council of Medical Research 45

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

52 A pilot study of HIV in women attending a health clinic in Mumbai

Principal Investigator Funded by Dr. Jayanthi Shastri Centre for AIDS Research (CFAR), USA Professor & Head, Topiwala National Medical College, Nair Hospital & Kasturba Hospital, Mumbai-400008 Date of approval March 25, 2008* Total budget Rs 9, 00, 000 Duration 6 Months Subject area HIV/AIDS/ STD

53 The detection of occult hepatitis B virus infection using real time PCR on pooled serum samples among HIV positive individuals in Southern India

Principal Investigator Funded by Dr. S Saravanan Center for AIDS Research (CFAR), USA Assistant Professor, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 8, 2011 Chennai-600113 Total budget Rs 17, 89, 470 Duration 12 Months Subject area HIV/AIDS/ STD

54 Incidence of Cryptosporidium in children among different hospitals in Kolkata

Principal Investigator Funded by Dr. Sandipan Ganguly Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Scientist C, National Institute of Cholera and Enteric Diseases (NICED), P-33, CIT Road, Scheme XM, Date of approval June 23, 2008 Beliaghata, Kolkata-700010 Total budget Rs 8, 00,000 Duration 12 Months Subject area Diarrhoeal Diseases

* Approved with conditions

Indian Council of Medical Research 47

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

52 A pilot study of HIV in women attending a health clinic in Mumbai 55 Direct and indirect protection by influenza vaccine given to children in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Jayanthi Shastri Centre for AIDS Research (CFAR), USA Dr. Shobha Broor Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Professor & Head, Professor, Topiwala National Medical College, All India Institute of Medical Sciences Nair Hospital & Kasturba Hospital, (AIIMS), Ansari Nagar, Mumbai-400008 New Delhi-110029 Date of approval March 25, 2008* Date of approval December 22, 2008* Total budget Rs 9, 00, 000 Total budget Rs 9, 41, 37,430 Duration 6 Months Duration 36 Months Subject area HIV/AIDS/ STD Subject area Influenza

53 The detection of occult hepatitis B virus infection using real time PCR on pooled serum samples 56 Influenza disease burden in rural communities in India among HIV positive individuals in Southern India

Principal Investigator Funded by Principal Investigator Funded by Dr. S Saravanan Center for AIDS Research (CFAR), USA Dr. A C Mishra Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Assistant Professor, Scientist G & Director, Y R Gaitonde Centre for AIDS National Institute of Virology (NIV), Research and Education (YRG CARE), 20-A, Dr.Ambedkar Road, Voluntary Health Services, Taramani, Pune-411001 Date of approval December 8, 2011 Date of approval December 22, 2008 Chennai-600113 Total budget Rs 17, 89, 470 Total budget Rs 5, 95, 71, 200 Duration 12 Months Duration 36 Months Subject area HIV/AIDS/ STD Subject area Influenza

54 Incidence of Cryptosporidium in children among different hospitals in Kolkata 57 Multi site epidemiological and virological monitoring of human influenza virus surveillance network in India, Phase II

Principal Investigator Funded by Principal Investigator Funded by Dr. Sandipan Ganguly Centers for Disease Control and Prevention/CDC Dr. A C Mishra Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Foundation, DHHS, Atlanta, USA Scientist C, Scientist G & Director, National Institute of Cholera and National Institute of Virology (NIV), Enteric Diseases (NICED), 20-A, Dr.Ambedkar Road, P-33, CIT Road, Scheme XM, Pune-411001 Date of approval June 23, 2008 Date of approval December 8, 2009* Beliaghata, Kolkata-700010 Total budget Rs 8, 00,000 Total budget Rs 1, 44, 31,359 Duration 12 Months Duration 60 Months Subject area Diarrhoeal Diseases Subject area Influenza

* Approved with conditions * Approved with conditions

Indian Council of Medical Research 47 48

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

58 Direct and indirect protection by influenza vaccine given to children in India: Immunogenicity

Principal Investigator Funded by Dr. Shobha Broor Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 8, 2010 Total budget Rs 1, 72, 76,176 Duration 12 Months Subject area Influenza

59 Epidemiological study of respiratory pathogens in acute respiratory tract infection among children and elderly in India

Principal Investigator Funded by Dr. Anand Krishnan Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Additional Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012 Total budget Rs 21, 82, 50, 000 Duration 60 Months Subject area Other Infectious Diseases

60 Influenza immunization of children in India

Principal Investigator Funded by Dr. Shobha Broor Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012 * Total budget Rs 9, 36, 56,096 Duration 36 Months Subject area Influenza

* Approved with a suggestion

49

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

58 Direct and indirect protection by influenza vaccine given to children in India: Immunogenicity 61 Studies on HRP2 and HRP3 expression in Plasmodium falciparum parasites from endemic States of India: A prospective evaluation

Principal Investigator Funded by Principal Investigator Funded by Dr. Shobha Broor Centers for Disease Control and Prevention/CDC Dr. Neeru Singh Centers for Disease Control and Prevention/CDC Foundation, DHHS, Atlanta, USA Foundation, DHHS, Atlanta, USA Professor, Scientist G & Director, All India Institute of Medical Sciences Regional Medical Research Centre for (AIIMS), Ansari Nagar, Tribals (RMRCT), New Delhi-110029 Nagpur Road, Garha, Date of approval September 8, 2010 Date of approval June 18, 2012 Jabalpur-482003 Total budget Rs 1, 72, 76,176 Total budget Rs 49, 32, 776 Duration 12 Months Duration 18 Months Subject area Influenza Subject area Malaria

59 Epidemiological study of respiratory pathogens in acute respiratory tract infection among children 62 District evaluation study of health: Disseminating evidence on disease control priorities in India and elderly in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Anand Krishnan Centers for Disease Control and Prevention/CDC Dr. Shreelata Rao Seshadri Center for Global Health Research, University of Foundation, DHHS, Atlanta, USA Toronto, Canada Additional Professor, Resident Director (Evaluations), All India Institute of Medical Sciences St. Johns Medical College, St. Johns (AIIMS), Ansari Nagar, Research Institute, St. Johns National New Delhi-110029 Academy of Health Sciences, Date of approval March 12, 2012 Date of approval September 10, 2012 * Koramangala, Sarjapur Road, Total budget Rs 21, 82, 50, 000 Bangalore-560034 Total budget Rs 91, 44,405 Duration 60 Months Duration 36 Months Subject area Other Infectious Diseases Subject area Health Systems Research

60 Influenza immunization of children in India 63 Evaluation of point-of-care tests for measurement of CD4+ T- cell absolute count and percentage for the immunological assessment of HIV / AIDS patients

Principal Investigator Funded by Principal Investigator Funded by Dr. Shobha Broor Centers for Disease Control and Prevention/CDC Dr. Madhuri Thakar Clinton Foundation (India office), New Delhi Foundation, DHHS, Atlanta, USA Professor, Scientist D, All India Institute of Medical Sciences National AIDS Research Institute (AIIMS), Ansari Nagar, (NARI), 73 G Block, MIDC, Bhosari, New Delhi-110029 Post Box No. 1875, Date of approval March 12, 2012 * Date of approval March 8, 2011 Pune-411026 Total budget Rs 9, 36, 56,096 Total budget Rs 6, 21, 130 Duration 36 Months Duration 12 Months Subject area Influenza Subject area HIV/AIDS/ STD

* Approved with a suggestion * Approved with conditions

Indian Council of Medical Research 49 50

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

64 Preparing sites for conducting effectiveness trials of microbicides in India

Principal Investigator Funded by Dr. Nomita Chandhiok Contraceptive Research and Development Program (CONRAD), USA Scientist E, Indian Council Medical Research (ICMR), Ansari Nagar, New Delhi-110029 Date of approval March 25, 2008* Total budget Rs 1, 68, 12,960 Duration 18 Months Subject area Reproductive Health

65 Molecular assay of insecticide resistance development in major vectors of malaria (Anopheles culicifacies and An.stephensi) in India

Principal Investigator Funded by Dr. B K Tyagi University of Copenhagen, Denmark Scientist F & Officer in Charge, Centre for Research in Medical Entomology (CRME), 4 Sarojani Street, Chinna Chokkikulam, Date of approval March 25, 2008 ** Madurai-625002 Total budget Rs 83, 00,000 Duration 36 Months Subject area Malaria

66 Assessment of therapeutic efficacy of Artemether-Lumefantrine in uncomplicated falciparum malaria

Principal Investigator Funded by Dr. Neena Valecha Dalarna University College, Sweden Scientist G & Director, National Institute of Malaria Research (NIMR), 22, Sham Nath Marg, New Delhi-110054 Date of approval June 23, 2008 Total budget Not Requested d Duration 24 Months Subject area Malaria

* Approved with condition

** Approved with condition for technical collaboration only (funded by DST)

51

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

64 Preparing sites for conducting effectiveness trials of microbicides in India 67 A double blind, randomized parallel, placebo control design study to determine the effect of addition of vitamin D to conventional anti TB therapy

Principal Investigator Funded by Principal Investigator Funded by Dr. Nomita Chandhiok Contraceptive Research and Development Dr. Dilip Mathai Dalhousie University, Internal Medicine Program (CONRAD), USA Research Foundation, Canada Scientist E, Head, Indian Council Medical Research Christian Medical College & Hospital, (ICMR), Ansari Nagar, Ida Scudder Road, New Delhi-110029 Vellore-632004 Date of approval March 25, 2008* Date of approval June 8, 2009 Total budget Rs 1, 68, 12,960 Total budget Rs 19, 06,200 Duration 18 Months Duration 24 Months Subject area Reproductive Health Subject area Tuberculosis

65 Molecular assay of insecticide resistance development in major vectors of malaria (Anopheles 68 Role of probiotics on growth and morbidity in children culicifacies and An.stephensi) in India

Principal Investigator Funded by Principal Investigator Funded by Dr. B K Tyagi University of Copenhagen, Denmark Dr. R Hemalatha Danisco, Finland Scientist F & Officer in Charge, Scientist E, Centre for Research in Medical National Institute of Nutrition (NIN), Entomology (CRME), 4 Sarojani Street, Jamai Osmania, Tarnaka, Chinna Chokkikulam, Hyderabad-500007 Date of approval March 25, 2008 ** Date of approval June 8, 2009 Madurai-625002 Total budget Rs 83, 00,000 Total budget Rs 39, 59,420 Duration 36 Months Duration 24 Months Subject area Malaria Subject area Child Health

66 Assessment of therapeutic efficacy of Artemether-Lumefantrine in uncomplicated falciparum 69 Monitoring and assessing the impact of vaccination and other childhood interventions for both malaria Boys and Girls

Principal Investigator Funded by Principal Investigator Funded by Dr. Neena Valecha Dalarna University College, Sweden Dr. Anand Krishnan Danish Government (DANIDA through INDEPTH network) Scientist G & Director, Associate Professor, National Institute of Malaria Research All India Institute of Medical Sciences (NIMR), 22, Sham Nath Marg, (AIIMS), Ansari Nagar, New Delhi-110054 New Delhi-110029 Date of approval June 23, 2008 Date of approval June 8, 2011 Total budget Not Requested Total budget Rs 1, 46, 79,226 d Duration 24 Months Duration 48 Months Subject area Malaria Subject area Child Health

* Approved with condition

** Approved with condition for technical collaboration only (funded by DST)

Indian Council of Medical Research 51 Indian Council of Medical Research 52

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

70 TB chemoprophylaxis in the household contacts of the AFB sputum positive cases

Principal Investigator Funded by Dr. Srikanth P Tripathy Department for International Development (DFID), United Kingdom Scientist F, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval March 2, 2009 Pune-411026 Total budget Rs 4, 73,218 Duration 4 Months Subject area HIV/ Tuberculosis

71 Understanding delivery access and utilization of HIV services in Goa and Belgaum

Principal Investigator Funded by Dr. Raman Gangakhedkar Department for International Development (DFID), United Kingdom Scientist E, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval March 2, 2009 Pune-411026 Total budget Rs 10, 57,116 Duration 8 Months Subject area HIV/AIDS/ STD

72 Study to explore the criteria used by physicians for advising HIV test to TB patients in Pune district

Principal Investigator Funded by Dr. Srikanth P Tripathy Department for International Development (DFID), United Kingdom Scientist F, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval March 2, 2009 Pune-411026 Total budget Rs 25, 97, 488 Duration 6 Months Subject area HIV/ Tuberculosis

53

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

70 TB chemoprophylaxis in the household contacts of the AFB sputum positive cases 73 Impact of professional and peer counseling on adherence to antituberculosis treatment regimens in a TB clinic setting

Principal Investigator Funded by Principal Investigator Funded by Dr. Srikanth P Tripathy Department for International Development Dr. Srikanth P Tripathy Department for International Development (DFID), United Kingdom (DFID), United Kingdom Scientist F, Scientist F, National AIDS Research Institute (NARI), National AIDS Research Institute (NARI), 73 G Block, MIDC, 73 G Block, MIDC, Bhosari, Post Box No. 1875, Bhosari, Post Box No. 1875, Date of approval March 2, 2009 Date of approval March 2, 2009 Pune-411026 Pune-411026 Total budget Rs 4, 73,218 Total budget Rs 6, 53, 708 Duration 4 Months Duration 7 Months Subject area HIV/ Tuberculosis Subject area HIV/ Tuberculosis

71 Understanding delivery access and utilization of HIV services in Goa and Belgaum 74 Current challenges and opportunities for the integration of TB and HIV services for co-infected patients

Principal Investigator Funded by Principal Investigator Funded by Dr. Raman Gangakhedkar Department for International Development Dr. Seema Sahay Department for International Development (DFID), United Kingdom (DFID), United Kingdom Scientist E, Scientist D, National AIDS Research Institute (NARI), National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, 73 G Block, MIDC, Bhosari, Post Box No. 1875, Post Box No. 1875, Date of approval March 2, 2009 Date of approval March 2, 2009 Pune-411026 Pune-411026 Total budget Rs 10, 57,116 Total budget Rs 3, 20, 136 Duration 8 Months Duration 8 Months Subject area HIV/AIDS/ STD Subject area HIV/ Tuberculosis

72 Study to explore the criteria used by physicians for advising HIV test to TB patients in Pune 75 A multi centric trial to detect in vivo resistance of Plasmodium falciparum to artesunate in district patients with uncomplicated malaria

Principal Investigator Funded by Principal Investigator Funded by Dr. Srikanth P Tripathy Department for International Development Dr. Neena Valecha Department for International Development (DFID), United Kingdom (DFID), United Kingdom Scientist F, Scientist G & Director, National AIDS Research Institute (NARI), National Institute of Malaria Research 73 G Block, MIDC, (NIMR), Sector 8, Dwarka, Bhosari, Post Box No. 1875, New Delhi-110077 Date of approval March 2, 2009 Date of approval September 8, 2011 Pune-411026 Total budget Rs 25, 97, 488 Total budget Rs 44, 53, 029 Duration 6 Months Duration 24 Months Subject area HIV/ Tuberculosis Subject area Malaria

Indian Council of Medical Research 53 54

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

76 PRIME: Programme for improving mental health care

Principal Investigator Funded by Dr. Vikram Patel Department for International Development (DFID), United Kingdom Professor, Sangath Centre, 841/1 Alto Porvorim, * Goa-403521 Date of approval March 12, 2012 Total budget Rs 6, 84, 12,554 Duration 60 Months Subject area Mental Health 77 A randomized, open-label, parallel group, safety and efficacy study to evaluate different combination treatment regimens (co-administration), of either AmBisome and paromomycin, Ambisome and miltefosine, or paromomycin and miltefosine compared with Amphotericin B deoxycholate (the standard) therapy for the treatment of acute, symptomatic Visceral Leishmaniasis (VL) Principal Investigator Funded by Dr. Shyam Sundar Drugs for Neglected Diseases Initiative (DNDi), Professor, Switzerland Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 Date of approval March 25, 2008 Total budget Rs 87, 93,750 Duration 18 Months Subject area Leishmaniasis

78 A pilot project to evaluate the safety and effectiveness of new treatment modalities for the management of Visceral Leishmaniasis (VL) in the endemic regions of India

Principal Investigator Funded by Dr. Pradeep Das Drugs for Neglected Diseases Initiative (DNDi), Switzerland Scientist G & Director, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Agamkuan, Date of approval March 12, 2012 Patna-800007 Total budget Rs 29, 56,580 Duration 60 Months Subject area Leishmaniasis

* Approved for AIIMS, New Delhi only with conditions

55

ResearchResearch ProjectsProjects ApprovedApproved by by HMSC HMSC

S.no. Detail of Projects

79 Levamisole treatment for children with Steroid Sensitive Nephrotic Syndrome (SSNS): A multi- centre, double-blind, placebo-controlled, randomized clinical trial

Principal Investigator Funded by Dr. Arvind Bagga Dutch Kidney Foundation, Netherlands Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 25, 2008* Total budget Rs 16, 45,548 Duration 24 Months Subject area Child Health

80 Effect of duloxetine 30/60mg once daily versus placebo in adolescents with juvenile primary fibromyalgia syndrome (Protocol FIJ-MC-HMGW)

Principal Investigator Funded by Dr. Pratap Sharan Eli Lilly & Company (India) Pvt Ltd. Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 10, 2012* * Total budget Rs 22, 75,416 Duration 36 Months Subject area Mental Health

81 Development of a DNA vaccine for Visceral Leishmaniasis (VL)

Principal Investigator Funded by Dr. Pradeep Das European Union Scientist G & Director, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Agam-kuan, Date of approval December 22, 2008 Patna-800007 Total budget Rs 1, 92, 78,000 Duration 36 Months Subject area Leishmaniasis

* Approved with conditions ** Approved for AIIMS, New Delhi only with conditions

56

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

82 New tools for monitoring drug resistance and treatment response in Visceral Leishmaniasis (VL) in the Indian subcontinent

Principal Investigator Funded by Dr. Poonam Salotra European Union Scientist E, Institute of Pathology, Safdarjung Hospital Campus, Post Box 4909, Date of approval December 22, 2008 New Delhi-110029 Total budget Rs 3, 70, 00,000 Duration 48 Months Subject area Leishmaniasis

83 Pre-clinical studies of a PSA-based human vaccine candidate targeting visceral, cutaneous and mucocutaneous leishmaniasis and development of the associated procedures for further clinical trials

Principal Investigator Funded by Dr. Poonam Salotra European Union Scientist E, Institute of Pathology, Safdarjung Hospital Campus, Post Box 4909, Date of approval December 22, 2008 New Delhi-110029 Total budget Rs 2, 15, 00,000 Duration 36 Months Subject area Leishmaniasis

84 Production and delivery of antibody fragments against gastrointestinal pathogens by lactobacilli

Principal Investigator Funded by Dr. Gagandeep Kang European Union Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval June 8, 2009 Total budget Rs 4, 63, 91,916 Duration 36 Months Subject area Gastroenterology

57

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

82 New tools for monitoring drug resistance and treatment response in Visceral Leishmaniasis (VL) 85 Prevalence and molecular characterization of S. pneumoniae in Chandigarh, North India in the Indian subcontinent

Principal Investigator Funded by Principal Investigator Funded by Dr. Poonam Salotra European Union Dr. Anuradha Chakraborti European Union Scientist E, Professor, Institute of Pathology, Post Graduate Institute of Medical Safdarjung Hospital Campus, Education and Research (PGIMER), Post Box 4909, Sector 12-D, Date of approval December 22, 2008 Date of approval December 8, 2009 New Delhi-110029 Chandigarh-160012 Total budget Rs 3, 70, 00,000 Total budget Rs 61, 00, 000 Duration 48 Months Duration 36 Months Subject area Leishmaniasis Subject area Bacteriology

83 Pre-clinical studies of a PSA-based human vaccine candidate targeting visceral, cutaneous and 86 Sustaining research momentum over the coming decades mentoring the next generation of mucocutaneous leishmaniasis and development of the associated procedures for further clinical researcher for Tuberculosis trials

Principal Investigator Funded by Principal Investigator Funded by Dr. Poonam Salotra European Union Dr. S K Sharma European Union Scientist E, Professor & Head, Institute of Pathology, All India Institute of Medical Sciences Safdarjung Hospital Campus, (AIIMS), Ansari Nagar, Post Box 4909, New Delhi-110029 Date of approval December 22, 2008 Date of approval December 8, 2009 New Delhi-110029 Total budget Rs 2, 15, 00,000 Total budget Rs 92, 00, 000 Duration 36 Months Duration 36 Months Subject area Leishmaniasis Subject area Tuberculosis

84 Production and delivery of antibody fragments against gastrointestinal pathogens by lactobacilli 87 Sustaining research momentum over the coming decades mentoring the next generation of researcher for Tuberculosis

Principal Investigator Funded by Principal Investigator Funded by Dr. Gagandeep Kang European Union Dr. Alladi Mohan European Union Professor, Professor & Head, Christian Medical College & Hospital, Sri Venkateswara Institute of Medical Ida Scudder Road, Sciences, Alipiri Road, Vellore-632004 Tirupati-517507 Date of approval June 8, 2009 Date of approval December 8, 2009 Total budget Rs 4, 63, 91,916 Total budget Rs 92, 00, 000 Duration 36 Months Duration 36 Months Subject area Gastroenterology Subject area Tuberculosis

Indian Council of Medical Research 57 Indian Council of Medical Research 58

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

88 The prevalence, cost and basis of Food Allergy in India "EUROPREVALL"

Principal Investigator Funded by Dr. Mahesh P A European Union Director, Allergy Asthma Associate, 1397, 4th West Cross, Krishnamurthypuram, Date of approval June 8, 2010 Mysore-570004 Total budget Rs 43, 35,000 Duration 24 Months Subject area Nutrition

89 Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial - A randomised controlled trial of fixed combination medication and usual care in those at high risk of cardiovascular disease

Principal Investigator Funded by Dr. D Prabhakaran European Union Executive Director, Center for Chronic Disease Control (CCDC), C1/52, Second Floor, Safdarjung Development Area, Date of approval June 8, 2010 * New Delhi-110016 Total budget Rs 5, 78, 52, 206 Duration 36 Months Subject area Cardiovascular Diseases

90 Capacity building program to improve the durability of first line HAART and to scale up low- cost, low-tech disease monitoring techniques

Principal Investigator Funded by Dr. Anita Shet European Union Associate Professor, St. Johns Medical College, St. Johns Research Institute, St. Johns National * Academy of Health Sciences, Date of approval September 8, 2010 Koramangala, Sarjapur Road, Bangalore-560034 Total budget Rs 4, 12, 40,028 Duration 48 Months Subject area HIV/AIDS/ STD

* Approved with conditions

59

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

88 The prevalence, cost and basis of Food Allergy in India "EUROPREVALL" 91 Impact of a package of intensive smoking-cessation interventions versus recommended, basic smoking-cessation advice on outcomes in smear-positive patients with pulmonary tuberculosis: A randomized controlled trial Principal Investigator Funded by Principal Investigator Funded by Dr. Mahesh P A European Union Dr. Alladi Mohan European Union Director, Professor & Head, Allergy Asthma Associate, Sri Venkateswara Institute of Medical 1397, 4th West Cross, Sciences, Alipiri Road, Krishnamurthypuram, Tirupati-517507 Date of approval June 8, 2010 Date of approval September 8, 2010 Mysore-570004 Total budget Rs 43, 35,000 Total budget Rs 92, 00,100 Duration 24 Months Duration 36 Months Subject area Nutrition Subject area Life Style Diseases

89 Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial - A randomised 92 Impact of a package of intensive smoking-cessation interventions versus recommended, basic controlled trial of fixed combination medication and usual care in those at high risk of smoking-cessation advice on outcomes in smear-positive patients with pulmonary tuberculosis: A cardiovascular disease randomized controlled trial

Principal Investigator Funded by Principal Investigator Funded by Dr. D Prabhakaran European Union Dr. S K Sharma European Union Executive Director, Professor & Head, Center for Chronic Disease Control All India Institute of Medical Sciences (CCDC), C1/52, Second Floor, (AIIMS), Ansari Nagar, Safdarjung Development Area, New Delhi-110029 Date of approval June 8, 2010 * Date of approval September 8, 2010 New Delhi-110016 Total budget Rs 5, 78, 52, 206 Total budget Rs 91, 10,220 Duration 36 Months Duration 36 Months Subject area Cardiovascular Diseases Subject area Life Style Diseases

90 Capacity building program to improve the durability of first line HAART and to scale up low- 93 Syndromic approach to Neglected Infectious Diseases (NID) at primary health care level: An cost, low-tech disease monitoring techniques international collaboration on integrated diagnosis-treatment platforms

Principal Investigator Funded by Principal Investigator Funded by Dr. Anita Shet European Union Dr. Shyam Sundar European Union Associate Professor, Professor, St. Johns Medical College, St. Johns Institute of Medical Sciences, Research Institute, St. Johns National Banaras Hindu University, * Varanasi-221005 Academy of Health Sciences, Date of approval September 8, 2010 Date of approval March 8, 2011* Koramangala, Sarjapur Road, Bangalore-560034 Total budget Rs 4, 12, 40,028 Total budget Rs 2, 12, 86,646 Duration 48 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Other Infectious Diseases

* Approved with conditions * Approved with conditions

Indian Council of Medical Research 59 Indian Council of Medical Research 60

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

94 A comparison of two innovative programs using 'push and pull' financial incentives to reduce maternal mortality in two states of India

Principal Investigator Funded by Dr. Dileep Mavalankar European Union Dean, Indian Institute of Public Health, Gandhinagar, Sardar Patel Institute Campus, Drive-in Road, Thaltej, Date of approval September 8, 2011 Ahmedabad-380054 Total budget Rs 1, 46, 43,144 Duration 48 Months Subject area Reproductive Health

95 A treatment oriented research project of NCL disorders as a major cause of dementia in childhood

Principal Investigator Funded by Dr. Pratibha Singhi European Union Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval September 8, 2011* Chandigarh-160012 Total budget Rs 58, 10, 000 Duration 36 Months Subject area Child Health

96 Protocol for correlating enteropathic severity and small intestinal CYP3A4 activity in patients with celiac disease

Principal Investigator Funded by Dr. Govind Makharia Flamentera AG, Basel, Switzerland Additional Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010 Total budget Rs 11, 00, 000 Duration 12 Months Subject area Gastroenterology

* Approved with conditions

61

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

94 A comparison of two innovative programs using 'push and pull' financial incentives to reduce 97 Protocol for correlating enteropathic severity and small intestinal CYP3A4 activity in patients maternal mortality in two states of India with celiac disease: A follow up study

Principal Investigator Funded by Principal Investigator Funded by Dr. Dileep Mavalankar European Union Dr. Govind Makharia Flamentera AG, Basel, Switzerland Dean, Additional Professor, Indian Institute of Public Health, All India Institute of Medical Sciences Gandhinagar, Sardar Patel Institute (AIIMS), Ansari Nagar, Campus, Drive-in Road, Thaltej, New Delhi-110029 Date of approval September 8, 2011 Date of approval March 12, 2012 Ahmedabad-380054 Total budget Rs 1, 46, 43,144 Total budget Rs 16, 13,295 Duration 48 Months Duration 12 Months Subject area Reproductive Health Subject area Gastroenterology Inhibitor development in Previously Untreated Patients (PUPs) or Minimally Blood Component- 95 A treatment oriented research project of NCL disorders as a major cause of dementia in childhood 98 Treatment Patients (MBCTPs) when exposed to plasma- derived von willebrand factor-containing factor VIII concentrates and to recombinant factor VIII concentrates: An independent, international, multicentre, prospective, controlled, randomized, open label, clinical trial

Principal Investigator Funded by Principal Investigator Funded by Dr. Pratibha Singhi European Union Dr. K Ghosh Fondazione Angelo Bianchi Bonomi, Italy Professor, Scientist G & Director, Post Graduate Institute of Medical National Institute of Immunohaematology Education and Research (PGIMER), (NIIH), 13th Floor, New Multi-Storied Sector 12-D, Building, KEM Hospital Campus, Date of approval September 8, 2011* Date of approval September 8, 2010 * Chandigarh-160012 Mumbai-400012 Total budget Rs 58, 10, 000 Total budget Rs 20, 00,000 Duration 36 Months Duration 60 Months Subject area Child Health Subject area Haematology Inhibitor development in Previously Untreated Patients (PUPs) or Minimally Blood Component- 96 Protocol for correlating enteropathic severity and small intestinal CYP3A4 activity in patients 99 Treatment Patients (MBCTPs) when exposed to plasma- derived von willebrand factor-containing with celiac disease factor VIII concentrates and to recombinant factor VIII concentrates: An independent, international, multicentre, prospective, controlled, randomized, open label, clinical trial

Principal Investigator Funded by Principal Investigator Funded by Dr. Govind Makharia Flamentera AG, Basel, Switzerland Dr.Tulika Seth Fondazione Angelo Bianchi Bonomi, Italy Additional Professor, Associate Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval December 8, 2010 Date of approval September 8, 2010 ** Total budget Rs 11, 00, 000 Total budget Rs 20, 00,000 Duration 12 Months Duration 60 Months Subject area Gastroenterology Subject area Haematology

* Approved with conditions * Approved with conditions ** Approval for transfer of 10% biological samples in HMSC meeting held on September 8, 2011

Indian Council of Medical Research 61 Indian Council of Medical Research 62

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects Inhibitor development in Previously Untreated Patients (PUPs) or Minimally Blood Component- 100 Treatment Patients (MBCTPs) when exposed to plasma- derived von willebrand factor-containing factor VIII concentrates and to recombinant factor VIII concentrates: An independent, international, multicentre, prospective, controlled, randomized, open label, clinical trial

Principal Investigator Funded by Dr. Ram Kumar Marwaha Fondazione Angelo Bianchi Bonomi, Italy Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval September 8, 2010 * Chandigarh-160012 Total budget Rs 20, 00,000 Duration 60 Months Subject area Haematology

101 Spatio-epidemiological analysis of dengue in Delhi (AEDES)

Principal Investigator Funded by Dr. B N Nagpal French National Grant (Agence National de la Recherche), France Scientist E, National Institute of Malaria Research (NIMR), Sector-8, Dwarka, New Delhi-110077 Date of approval December 10, 2012 Total budget Rs 32, 98,960 Duration 24 Months Subject area Dengue

102 A randomized, multicentre, phase III open label study of the efficacy and safety of Trastuzumab- MCC-DM1 vs. Capecitabine + Lapatinib in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior Trastuzumab based therapy

Principal Investigator Funded by Dr. Vinod Raina Genentech, Inc., USA and Hoffmann La Roche Ltd, Switzerland Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2011** Total budget Not Requested Duration 36 Months Subject area Oncology

* Approved with conditions ** Approved for 4 study sites only

Indian Council of Medical Research 63

Research Projects Approved by HMSC Research ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects Inhibitor development in Previously Untreated Patients (PUPs) or Minimally Blood Component- 100 Treatment Patients (MBCTPs) when exposed to plasma- derived von willebrand factor-containing 103 A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. factor VIII concentrates and to recombinant factor VIII concentrates: An independent, Chlorambucil monotherapy in previously untreated patients with chronic lymphocytic leukemia international, multicentre, prospective, controlled, randomized, open label, clinical trial Principal Investigator Funded by Principal Investigator Funded by Dr. Vinod Raina Glaxo Smith Kline Dr. Ram Kumar Marwaha Fondazione Angelo Bianchi Bonomi, Italy Professor & Head, Professor, Post Graduate Institute of Medical All India Institute of Medical Sciences Education and Research (PGIMER), (AIIMS), Ansari Nagar, New Delhi-110029 Sector 12-D, Date of approval September 8, 2010 * Date of approval June 18, 2012 Chandigarh-160012 Total budget Rs 20, 00,000 Total budget To be decided Duration 60 Months Duration 24 Months Subject area Haematology Subject area Oncology

101 Spatio-epidemiological analysis of dengue in Delhi (AEDES) 104 A multi-centre, double-blind, randomized, parallel group, active-controlled study to evaluate the efficacy, safety and tolerability of tafenoquine (SB-252263, WR238605) in subjects with Plasmodium vivax malaria

Principal Investigator Funded by Principal Investigator Funded by Dr. B N Nagpal French National Grant (Agence National de la Dr. Anupkumar Anvikar Glaxo Smith Kline Recherche), France Scientist E, Scientist D, National Institute of Malaria Research National Institute of Malaria Research (NIMR), Sector-8, Dwarka, (NIMR), Sector 8, Dwarka, New Delhi-110077 New Delhi-110077 Date of approval December 10, 2012 Date of approval June 18, 2012 * Total budget Rs 32, 98,960 Total budget Rs 14, 85,150 Duration 24 Months Duration 24 Months Subject area Dengue Subject area Malaria

102 A randomized, multicentre, phase III open label study of the efficacy and safety of Trastuzumab- 105 Pilot study of an indicator to measure intrapartum stillbirth and immediate neonatal death MCC-DM1 vs. Capecitabine + Lapatinib in patients with HER2-positive locally advanced or (ISINDI) metastatic breast cancer who have received prior Trastuzumab based therapy

Principal Investigator Funded by Principal Investigator Funded by Dr. Vinod Raina Genentech, Inc., USA and Hoffmann La Roche Dr. Archana Patel Global Alliance through Research Triangle Ltd, Switzerland Institute, USA Professor & Head, Professor & Head, All India Institute of Medical Sciences Lata Medical Research Foundation, (AIIMS), Ansari Nagar, Kinkine Kutir, Vasant Nagar Colony New Delhi-110029 Near Deeksha Bhoomi Square Date of approval December 8, 2011** Date of approval March 12, 2012 Nagpur-440022 Total budget Not Requested Total budget Rs 68,000 Duration 36 Months Duration 6 Months Subject area Oncology Subject area Child Health

* Approved with conditions * Approved with conditions ** Approved for 4 study sites only

Indian Council of Medical Research 63 64

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

106 Pilot study of an indicator to measure Intrapartum Stillbirth and Immediate Neonatal Death (ISINDI)

Principal Investigator Funded by Dr. Bhalachandra S Kodkany Global Alliance to Prevent Prematurity and Stillbirth Maternal Health Task Force, USA Professor, Jawaharlal Nehru Medical College, JNMC Campus, Nehru Nagar, Belgaum-590010 Date of approval December 8, 2011 Total budget Rs 4, 40,000 Duration 6 Months Subject area Reproductive Health

107 Implementation research for point of care diagnosis of visceral leishmaniasis in India

Principal Investigator Funded by Dr. Pradeep Das Grand Challenges, Canada Scientist G & Director, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Agam-kuan, Date of approval September 8, 2011 Patna-800007 Total budget Rs 3, 78, 23,659 Duration 36 Months Subject area Leishmaniasis

GWCA 1103: A two - part, placebo - controlled, study of the safety and efficacy of sativex 108 oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy

Principal Investigator Funded by Dr. Sushma Bhatnagar GW Pharma Ltd, Wiltshire, UK Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, Date of approval June 18, 2012 New Delhi-110029 Total budget Rs 1, 06,080 Duration 47 Months Subject area Oncology

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Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

106 Pilot study of an indicator to measure Intrapartum Stillbirth and Immediate Neonatal Death 109 Treatment approaches for pre eclampsia in low resource settings (ISINDI)

Principal Investigator Funded by Principal Investigator Funded by Dr. Bhalachandra S Kodkany Global Alliance to Prevent Prematurity and Dr. Annie Regi Gynuity Health Projects, USA Stillbirth Maternal Health Task Force, USA Professor, Professor & Head, Jawaharlal Nehru Medical College, Christian Medical College & Hospital, JNMC Campus, Nehru Nagar, Ida Scudder Road, Belgaum-590010 Vellore-632004 Date of approval December 8, 2011 Date of approval June 8, 2009 Total budget Rs 4, 40,000 Total budget Rs 6, 78,500 Duration 6 Months Duration 12 Months Subject area Reproductive Health Subject area Reproductive Health

107 Implementation research for point of care diagnosis of visceral leishmaniasis in India 110 An evaluation of a WHO safe childbirth checklist quality improvement program-single-centre pilot study

Principal Investigator Funded by Principal Investigator Funded by Dr. Pradeep Das Grand Challenges, Canada Dr. Bhalachandra S Kodkany Harvard School of Public Health, Boston, USA Scientist G & Director, Professor, Rajendra Memorial Research Institute Jawaharlal Nehru Medical College, of Medical Sciences (RMRIMS), JNMC Campus, Nehru Nagar, Agam-kuan, Belgaum-590010 Date of approval September 8, 2011 Date of approval September 8, 2010 Patna-800007 Total budget Rs 3, 78, 23,659 Total budget Rs 9, 03,232 Duration 36 Months Duration 6 Months Subject area Leishmaniasis Subject area Child Health

GWCA 1103: A two - part, placebo - controlled, study of the safety and efficacy of sativex 108 oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled 111 Better Birth: trial of the WHO safe childbirth checklist programe persistent chronic pain in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy Principal Investigator Funded by Principal Investigator Funded by Dr.Vishwajeet Kumar Harvard School of Public Health, Boston, USA Dr. Sushma Bhatnagar GW Pharma Ltd, Wiltshire, UK Investigator, Associate Professor, All India Institute of Medical Sciences Community Empowerment Lab, (AIIMS), Ansari Nagar, 3/259 Vishal Khand-III, Gomti Nagar, Date of approval June 18, 2012 Date of approval September 10, 2012 New Delhi-110029 Lucknow-226010 Total budget Rs 1, 06,080 Total budget Rs 35, 98,000 Duration 47 Months Duration 36 Months Subject area Oncology Subject area Reproductive Health

Indian Council of Medical Research 65 Indian Council of Medical Research 66

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects Study of food and nutrient consumption pattern with reference to pearl millet, its processing, 112 cooking and their effect on iron, zinc, phytate and polyphenols retention in women of child bearing age and under five children in Nagpur, a desert district of Rajasthan and a part of Indian pearl millet belt Principal Investigator Funded by Dr. Madhu B Singh Harvest Plus, Washington DC, USA Scientist E, Desert Medicine Research Centre, New Pali Road, Jodhpur-342005 Date of approval March 8, 2010* Total budget Rs 15, 94,740 Duration 12 Months Subject area Nutrition

113 Comparison of mifepristone plus misoprostol and misoprostol alone for inducing abortion at 13 - 20 weeks gestation: A double blind randomized multicentre trial

Principal Investigator Funded by Dr. Lakhbir Dhaliwal Ibis Reproductive Health and Concept Foundation, Geneva, Switzerland Head, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval March 12, 2012 Chandigarh-160012 Total budget Rs 11, 10,806 Duration 18 Months Subject area Reproductive Health

114 Comparison of mifepristone plus misoprostol and misoprostol alone for inducing abortion at 13 - 20 weeks gestation: A double blind randomized multicentre trial

Principal Investigator Funded by Dr. Suneeta Mittal Ibis Reproductive Health and Concept Foundation, Geneva, Switzerland Professor & Unit Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012 Total budget Rs 13, 57,180 Duration 18 Months Subject area Reproductive Health

* Supplementary budget of Rs. 3.72 lakh approved in HMSC meeting held on March 8, 2011

67

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects Study of food and nutrient consumption pattern with reference to pearl millet, its processing, 112 cooking and their effect on iron, zinc, phytate and polyphenols retention in women of child 115 Tranexamic Acid (TXA) for the treatment of post-partum haemorrhage: An international bearing age and under five children in Nagpur, a desert district of Rajasthan and a part of Indian randomized, double blind placebo controlled trial pearl millet belt Principal Investigator Funded by Principal Investigator Funded by Dr. Madhu B Singh Harvest Plus, Washington DC, USA Dr. Malabika Roy ICMR under ICMR-London School of Hygiene and Tropical Medicine, United Kingdom, MoU Scientist E, Head, Desert Medicine Research Centre, Indian Council Medical Research (ICMR), New Pali Road, Ansari Nagar, Jodhpur-342005 New Delhi-110029 Date of approval March 8, 2010* Date of approval December 8, 2011* Total budget Rs 15, 94,740 Total budget Rs 59, 59,000 Duration 12 Months Duration 48 Months Subject area Nutrition Subject area Reproductive Health

113 Comparison of mifepristone plus misoprostol and misoprostol alone for inducing abortion at 13 - 116 Overweight and obesity in Asian Indian children in India and Canada: Multi-level determinants, 20 weeks gestation: A double blind randomized multicentre trial functional consequences and novel mechanism

Principal Investigator Funded by Principal Investigator Funded by Dr. Lakhbir Dhaliwal Ibis Reproductive Health and Concept Dr. Mario Vaz ICMR under ICMR - Canadian Institutes of Foundation, Geneva, Switzerland Health Research (CIHR), Canada MoU Head, Professor & Head, Post Graduate Institute of Medical St. Johns Medical College and Institute Education and Research (PGIMER), of Population Health and Clinical Sector 12-D, Research(IPHCR) , St. Johns Research Date of approval March 12, 2012 Date of approval September 8, 2010 Chandigarh-160012 Institute, Sarjapur Road, Total budget Rs 11, 10,806 Bangalore-560034 Total budget Rs 48, 86,700 Duration 18 Months Duration 36 Months Subject area Reproductive Health Subject area Child Health

114 Comparison of mifepristone plus misoprostol and misoprostol alone for inducing abortion at 13 - 117 Understanding the determinants of adiposity among newborns of Indian ancestry in Canada and 20 weeks gestation: A double blind randomized multicentre trial India: The South Asian Birth Cohort (START)

Principal Investigator Funded by Principal Investigator Funded by Dr. Suneeta Mittal Ibis Reproductive Health and Concept Dr. Krishnamachari Srinivasan ICMR under ICMR - Canadian Institutes of Foundation, Geneva, Switzerland Health Research (CIHR), Canada MoU Professor & Unit Head, Vice Dean, All India Institute of Medical Sciences St. Johns Medical College, St. Johns (AIIMS), Ansari Nagar, Research Institute, St. Johns National New Delhi-110029 Academy of Health Sciences, Date of approval March 12, 2012 Date of approval September 8, 2010 Koramangala, Sarjapur Road, Total budget Rs 13, 57,180 Bangalore-560034 Total budget Rs 49, 56, 880 Duration 18 Months Duration 36 Months Subject area Reproductive Health Subject area Child Health

* Supplementary budget of Rs. 3.72 lakh approved in HMSC meeting held on March 8, 2011 * Approved only for 17 centres with certain conditions and funds of Rs 93, 28,000 from LSHTM & Rs 59, 59,000 from ICMR

Indian Council of Medical Research 67 68

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

118 Foundational work for a brain to society diagnostic for prevention of childhood obesity and its chronic diseases consequences

Principal Investigator Funded by Prof. Narendra K Arora ICMR under ICMR - Canadian Institutes of Health Research (CIHR), Canada MoU Director, International Clinical Epidemiology Network (INCLEN), Executive office, F-1/5, 2nd Floor, Okhla Industrial Area, Date of approval March 8, 2011 Phase - I New Delhi-110020 Total budget Rs 50, 00, 000

Duration 60 Months Subject area Child Health

119 Hepatitis C Virus-Human Immunodeficiency Virus co-infection: Immune mechanisms, viral interactions and pathogenesis

Principal Investigator Funded by Dr. S K Sarin ICMR under ICMR-Helmholtz Association Institute of Liver Biliary Sciences, New Delhi (HGF), MoU Dr. Shahid Jameel International Centre for Genetic Engineering & Biotechnology, New Delhi * Dr. Rajni Rani Date of approval June 23, 2008 National Institute of Immunology, Total budget Rs 2, 24, 47,756 New Delhi & Dr. S Mahalingam Duration 36 Months Indian Institute of Technology- Madras, Subject area HIV/AIDS/ STD Chennai 120 Novel strategies to combat cholera

Principal Investigator Funded by Dr. Ranjan Kumar Nandy ICMR under ICMR-Helmholtz Association (HGF), MoU Scientist C, National Institute of Cholera and Enteric Diseases (NICED), P-33, CIT Road, Scheme XM, Date of approval June 23, 2008 Beliaghata, Kolkata-700010 Total budget Rs 35, 76,600 Duration 36 Months Subject area Diarrhoeal Diseases

* Extension of project with additional funds of Rs.38, 30,435 endorsed in HMSC meeting held on June 18, 2012

69

Research Projects Approved by HMSC Research ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

118 Foundational work for a brain to society diagnostic for prevention of childhood obesity and its 121 Novel strategies to combat leishmaniasis chronic diseases consequences

Principal Investigator Funded by Principal Investigator Funded by Prof. Narendra K Arora ICMR under ICMR - Canadian Institutes of Dr. Bhaskar Saha ICMR under ICMR-Helmholtz Association Health Research (CIHR), Canada MoU Scientist E, (HGF), MoU Director, National Center for Cell Science, International Clinical Epidemiology Ganeshkhind, Network (INCLEN), Executive office, Pune-411007 F-1/5, 2nd Floor, Okhla Industrial Area, Date of approval March 8, 2011 Dr. Pradeep Das Date of approval December 22, 2008 Phase - I New Delhi-110020 Total budget Rs 50, 00, 000 Scientist G & Director, Total budget Rs 1, 05, 33,612 Rajendra Memorial Research Institute Duration 60 Months of Medical Sciences (RMRIMS), Duration 36 Months Subject area Child Health Agam-kuan, Subject area Leishmaniasis Patna-800007

119 Hepatitis C Virus-Human Immunodeficiency Virus co-infection: Immune mechanisms, viral 122 Implications of the interferon system & immunogenetic basis of resistance to HIV -1 infection interactions and pathogenesis and disease progression

Principal Investigator Funded by Principal Investigator Funded by Dr. S K Sarin ICMR under ICMR-Helmholtz Association Prof. Narinder K. Mehra ICMR under ICMR-Helmholtz Association Institute of Liver Biliary Sciences, New Delhi (HGF), MoU (HGF), MoU Dr. Shahid Jameel Associate Professor & Head, International Centre for Genetic Engineering All India Institute of Medical Sciences & Biotechnology, New Delhi (AIIMS), Ansari Nagar, * New Delhi-110029 Dr. Rajni Rani Date of approval June 23, 2008 Date of approval March 2, 2009 Dr. Gurvinder Kaur National Institute of Immunology, Total budget Rs 2, 24, 47,756 Total budget Rs 59, 73,897 New Delhi & Scientist, All India Institute of Medical Sciences Dr. S Mahalingam Duration 36 Months Duration 36 Months (AIIMS), Ansari Nagar, Indian Institute of Technology- Madras, Subject area HIV/AIDS/ STD New Delhi-110029 Subject area HIV/AIDS/ STD Chennai

120 Novel strategies to combat cholera 123 Study of Hepatitis B Virus (HBV) resistance patterns in patients with chronic infection during therapy with nucleoside and nucleotide analogues

Principal Investigator Funded by Principal Investigator Funded by Dr. Ranjan Kumar Nandy ICMR under ICMR-Helmholtz Association Dr. Abhijit Chowdhury ICMR under ICMR-INSERM MoU (HGF), MoU Scientist C, Associate Professor, National Institute of Cholera and Institute of Post Graduate Medical Enteric Diseases (NICED), Education and Research (IPGMER), P-33, CIT Road, Scheme XM, 244 B, Acharya Jagadish Chandra Date of approval June 23, 2008 Date of approval March 2, 2009 Beliaghata, Bose Road, Kolkata-700010 Total budget Rs 35, 76,600 Kolkata-700020 Total budget Rs 37, 23,391

Duration 36 Months Duration 24 Months Subject area Diarrhoeal Diseases Subject area Other Infectious Diseases

* Extension of project with additional funds of Rs.38, 30,435 endorsed in HMSC meeting held on June 18, 2012

Indian Council of Medical Research 69 70

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

124 Bardet-Bield syndrome: Molecular epidemiology and identification of novel genes in the Indian cohort

Principal Investigator Funded by Dr. S Sripriya ICMR under ICMR-INSERM MoU Lecturer, Sankara Nethralaya Medical and Vision Research Foundation, 18, College Road, Nugambakkam, Date of approval March 2, 2009 * Chennai-600006 Total budget Rs 28, 74,400 Duration 36 Months Subject area Genomics

125 Designing a biobank for biological samples collected from a megastudy on acute coronary events in Indians

Principal Investigator Funded by Dr. Meenakshi Sharma ICMR under ICMR-INSERM MoU Scientist D, Indian Council Medical Research (ICMR), Ansari Nagar, New Delhi-110029 Date of approval June 8, 2009* * Total budget Rs 44, 58, 000 Duration 24 Months Subject area Cardiovascular Diseases

126 NK cell response diversity and cytokine/transcription factor profiles in SLE & RA South Indian patients

Principal Investigator Funded by Dr. Vir Singh Negi ICMR under ICMR-INSERM MoU Professor, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Dhanvantri Nagar, Date of approval June 8, 2009* ** Puducherry-605006 Total budget Rs 42, 34, 000 Duration 24 Months Subject area Immunology

* Change of PI from Dr G Kumaramanickavel to Dr S Sripriya endorsed in HMSC meeting held on September 8, 2009. Extension of project with additional funds of Rs 8, 55,724 approved in HMSC meeting held on June 8, 2011 ** Extension of project w.e.f. October 1, 2011 to May 31, 2012 with additional budget of Rs 20 lakh endorsed in HMSC meeting held on June 8, 2011 *** No cost extension for one year approved in HMSC meeting held on December 8, 2011 71

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

124 Bardet-Bield syndrome: Molecular epidemiology and identification of novel genes in the Indian 127 Mycobacterium tuberculosis and human dendritic cells: Deciphering molecular interactions of cohort novel cell wall antigens

Principal Investigator Funded by Principal Investigator Funded by Dr. S Sripriya ICMR under ICMR-INSERM MoU Dr. K N Balaji ICMR under ICMR-INSERM MoU Lecturer, Assistant Professor, Sankara Nethralaya Medical and Vision Indian Institute of Science, Research Foundation, Gulmohar Marg, Mathikere 18, College Road, Nugambakkam, Banaglore-560012 Date of approval March 2, 2009 * Date of approval June 8, 2009 Chennai-600006 Total budget Rs 28, 74,400 Total budget Rs 37, 81, 200 Duration 36 Months Duration 24 Months Subject area Genomics Subject area Tuberculosis

125 Designing a biobank for biological samples collected from a megastudy on acute coronary events 128 Evaluation of cellular and immune response in mice and patients with acute promyelocytic in Indians leukemia treated with arsenic trioxide

Principal Investigator Funded by Principal Investigator Funded by Dr. Meenakshi Sharma ICMR under ICMR-INSERM MoU Dr. Vikram Mathew ICMR under ICMR-INSERM MoU Scientist D, Professor, Indian Council Medical Research (ICMR), Christian Medical College & Hospital, Ansari Nagar, Ida Scudder Road, New Delhi-110029 Vellore- 632004 Date of approval June 8, 2009* * Date of approval June 8, 2010 Total budget Rs 44, 58, 000 Total budget Rs 52, 67,800 Duration 24 Months Duration 24 Months Subject area Cardiovascular Diseases Subject area Oncology

126 NK cell response diversity and cytokine/transcription factor profiles in SLE & RA South Indian 129 Cerebellum and cortical plasticity: The case of dystonia patients

Principal Investigator Funded by Principal Investigator Funded by Dr. Vir Singh Negi ICMR under ICMR-INSERM MoU Dr. Asha Kishore ICMR under ICMR-INSERM MoU Professor, Professor, Jawaharlal Institute of Postgraduate Sree Chitra Tirunal Institute for Medical Education & Research (JIPMER), Medical Sciences & Technology Dhanvantri Nagar, (SCTIMST), Trivandrum, Date of approval June 8, 2009* ** Date of approval June 8, 2010 Puducherry-605006 Thiruvananthapuram-695011 Total budget Rs 42, 34, 000 Total budget Rs 9, 23,440 Duration 24 Months Duration 24 Months Subject area Immunology Subject area Neurosciences

* Change of PI from Dr G Kumaramanickavel to Dr S Sripriya endorsed in HMSC meeting held on September 8, 2009. Extension of project with additional funds of Rs 8, 55,724 approved in HMSC meeting held on June 8, 2011 ** Extension of project w.e.f. October 1, 2011 to May 31, 2012 with additional budget of Rs 20 lakh endorsed in HMSC meeting held on June 8, 2011 *** No cost extension for one year approved in HMSC meeting held on December 8, 2011 Indian Council of Medical Research 71 Indian Council of Medical Research 72

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

130 Phenotypic and genotypic correlation of Autoimmune Lymphoproliferative Syndrome (ALPS)

Principal Investigator Funded by Dr. K Ghosh ICMR under ICMR-INSERM MoU Scientist G & Director, National Institute of Immunohaematology (NIIH), 13th Floor, New Multi-storied Building, KEM Date of approval June 8, 2010* Hospital Campus, Mumbai-400012 Total budget Rs 45, 59,600 Duration 24 Months Subject area Genomics

131 Influence of CYP2C9, VKORC1 and CYP4F2 genetic polymorphisium on plasma warfarin levels and development of an algorithm for initiating warfarin therapy in south Indian population

Principal Investigator Funded by Dr. D G Shewade ICMR under ICMR-INSERM MoU Professor, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry-605006 ** Date of approval June 8, 2010 Total budget Rs 45, 45,640 Duration 24 Months Subject area Genomics

132 Pharmaco-genetics of cytarabine and daunorubicin resistance in the leukemic stem cell compartment in acute myeloid leukemia

Principal Investigator Funded by Dr. Poonkuzhali Balasubramanian ICMR under ICMR-INSERM MoU Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval June 8, 2010 *** Total budget Rs 20, 07,000 Duration 24 Months Subject area Oncology

* Not approved by Joint Working Group of ICMR-INSERM ** Extension of the project for six months endorsed in HMSC meeting held on March 8, 2013 *** Approved with conditions

73

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

130 Phenotypic and genotypic correlation of Autoimmune Lymphoproliferative Syndrome (ALPS) 133 Molecular genetic profile of congenital stationary night blindness in India using Arrayed Primer Extension Technology (APEX) and direct sequencing to associate with disease phenotype

Principal Investigator Funded by Principal Investigator Funded by Dr. K Ghosh ICMR under ICMR-INSERM MoU Dr. Parveen Sen ICMR under ICMR-INSERM MoU Scientist G & Director, Senior Consultant, National Institute of Sankara Nethralaya Medical and Vision Immunohaematology (NIIH), 13th Floor, Research Foundation, New Multi-storied Building, KEM 41/18 College Road, Nugambakkam, Date of approval June 8, 2010* Date of approval June 8, 2010 * Hospital Campus, Chennai-600006 Mumbai-400012 Total budget Rs 45, 59,600 Total budget Rs 32, 13, 500 Duration 24 Months Duration 24 Months Subject area Genomics Subject area Genomics

131 Influence of CYP2C9, VKORC1 and CYP4F2 genetic polymorphisium on plasma warfarin levels 134 Clinical relevance of MICA and NKG2D genetic and phenotypic diversity in renal transplantation and development of an algorithm for initiating warfarin therapy in south Indian population

Principal Investigator Funded by Principal Investigator Funded by Dr. D G Shewade ICMR under ICMR-INSERM MoU Prof. Narinder K Mehra ICMR under ICMR-INSERM MoU Professor, Professor & Head, Jawaharlal Institute of Postgraduate All India Institute of Medical Sciences Medical Education & Research (JIPMER), (AIIMS), Ansari Nagar, Puducherry-605006 ** New Delhi-110029 Date of approval June 8, 2010 Date of approval June 8, 2010 ** Total budget Rs 45, 45,640 Total budget Rs 54, 66, 729 Duration 24 Months Duration 24 Months Subject area Genomics Subject area Genomics

132 Pharmaco-genetics of cytarabine and daunorubicin resistance in the leukemic stem cell 135 Proteolytic antibodies in immune mediated and infectious conditions: Role in health, disease and compartment in acute myeloid leukemia therapeutic implications

Principal Investigator Funded by Principal Investigator Funded by Dr. Poonkuzhali Balasubramanian ICMR under ICMR-INSERM MoU Dr. K Ghosh ICMR under ICMR-INSERM MoU Professor, Scientist G & Director, Christian Medical College & Hospital, National Institute of Immunohaematology Ida Scudder Road, (NIIH), 13th Floor, New Multi-storied Vellore-632004 Building, KEM Hospital Campus, Date of approval June 8, 2010 *** Date of approval June 8, 2011 Mumbai-400012 Total budget Rs 20, 07,000 Total budget Rs 2, 00, 00,000 Duration 24 Months Duration 48 Months Subject area Oncology Subject area Haematology

* Not approved by Joint Working Group of ICMR-INSERM * Change of PI from Dr. Madhavan Jagadeesan to Dr. Praveen Sen endorsed in HMSC meeting held on ** Extension of the project for six months endorsed in HMSC meeting held on March 8, 2013 September 8, 2011 Approved with conditions ** One year extension with additional budget of Rs. 9, 16,812 approved with conditions in HMSC meeting *** held on June 18, 2012

Indian Council of Medical Research 73 Indian Council of Medical Research 74

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

136 A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent Type 2 diabetes in India and the UK

Principal Investigator Funded by Dr. A Ramachandran ICMR under ICMR-Medical Research Council (MRC), United Kingdom MoU President, Indian Diabetes Research Foundation, No. 28 Marshall Road, Egmore, Chennai-600008 Date of approval September 8, 2011 Total budget Rs 97, 77,690 Duration 36 Months Subject area Diabetes

137 Maternal vitamin B12, folic acid and homocysteine as determinants of gestational diabetes, fetal growth and inter-generational programming of diabesity

Principal Investigator Funded by Dr. Chittaranjan S Yajnik ICMR under ICMR-Medical Research Council (MRC), United Kingdom MoU Director, KEM Hospital & Research Centre, 6th Floor, Banoo Coyaji Building, Rasta Peth, Date of approval September 8, 2011 Pune-411011 Total budget Rs 99, 79,220 Duration 48 Months Subject area Diabetes

138 Phenotypic characterization of non-smoking COPD

Principal Investigator Funded by Dr. Sundeep Santosh Salvi ICMR under ICMR-Medical Research Council (MRC), United Kingdom MoU Director, Chest Research Foundation, Marigold Complex, Kalyaninagar, Pune-411014 Date of approval September 8, 2011 Total budget Rs 1, 06, 46,106 Duration 42 Months Subject area Pulmonary Diseases

75

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139 Effects of a yoga-based cardiac rehabilitation programme (Yoga-CARE) on cardiovascular health: A clinical trial (India) and mechanistic study (UK)

Principal Investigator Funded by Dr. D Prabhakaran ICMR under ICMR-Medical Research Council (MRC), United Kingdom MoU Executive Director, Center for Chronic Disease Control (CCDC), C1/52, Second Floor, Safdarjung Development Area, Date of approval September 10, 2012 New Delhi-110016 Total budget Rs 1, 00, 06,170 * Duration 24 Months Subject area Cardiovascular Diseases

140 Development of blood outgrowth endothelial cell and nanofiber scaffold synergy in wound healing

Principal Investigator Funded by Dr. Shantikumar V Nair ICMR under ICMR-University of Minnesota (UoM), USA MoU Dean of Research, Amrita Vishwa Vidyapeetham, AIMS Ponekkara Post, Kochi-682041 Date of approval March 8, 2011* * Total budget Rs 4, 56,000 Duration 12 Months Subject area Diabetes

141 Diabetes: Genetic susceptibility in the population

Principal Investigator Funded by Dr. V Mohan ICMR under ICMR-University of Minnesota (UoM), USA MoU Director, Madras Diabetes Research Foundation, No-4, Conran Smith Road, Gopalapuram, Date of approval March 8, 2011* ** Chennai-600086 Total budget Rs 47, 90,000 Duration 24 Months Subject area Diabetes

* Rs 1,00, 06,170 from ICMR, India & Rs 1,77,56,738 from MRC, UK ** Extension for a period of one year with additional funds of Rs.8.1 lakhs approved in HMSC meeting held on September 10, 2012 *** Extension for a period of six months with no additional funds approved in HMSC meeting held on September 10, 2012

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

142 HLA haplotype frequency analysis within India: Pre-requisite for bone marrow donor registry and cord blood bank planning

Principal Investigator Funded by Dr. Dolly Daniel ICMR under ICMR-University of Minnesota (UoM), USA MoU Professor & Head, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval March 8, 2011 Total budget Rs 39, 26,120 Duration 24 Months Subject area Oncology

143 Persistent organic pollutants - environmental risk factors for diabetes mellitus? - A case control study

Principal Investigator Funded by Dr. R Sankaran ICMR under ICMR-University of Minnesota (UoM), USA MoU Director, PSG Institute of Medical Sciences and Research, Off Avanashi Road, Peelamedu, Date of approval March 8, 2011 Coimbatore-641004 Total budget Rs 25, 60,000 Duration 36 Months Subject area Diabetes

144 Development of chimeric genetic vaccine against Human Papillomavirus type 16

Principal Investigator Funded by Dr. Mausumi Bhardwaj ICMR under Indo-German Programme Scientist E, Institute of Cytology and Preventive Oncology (ICPO), 1-7, Sector-39, Near Degree College, Date of approval June 23, 2008 * NOIDA-201301 Total budget Rs 33, 33,600 Duration 36 Months Subject area Oncology

* The extension for one year with additional funds of Rs.10, 04,800 was endorsed in HMSC meeting held on September 10, 2012

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142 HLA haplotype frequency analysis within India: Pre-requisite for bone marrow donor registry and 145 The Influence of O-acetylated cell surface-expressed sialoglycans on angiogenesis of bone cord blood bank planning marrow associated leukemias

Principal Investigator Funded by Principal Investigator Funded by Dr. Dolly Daniel ICMR under ICMR-University of Minnesota Dr. Chitra Mandal ICMR under Indo-German Programme (UoM), USA MoU Professor & Head, Deputy Director, Christian Medical College & Hospital, Indian Institute of Chemical Biology, Ida Scudder Road, 4, Raja S C Mullick Road, Vellore-632004 Kolkata-700032 Date of approval March 8, 2011 Date of approval June 23, 2008 Total budget Rs 39, 26,120 Total budget Rs 29, 09,000 Duration 24 Months Duration 36 Months Subject area Oncology Subject area Oncology

143 Persistent organic pollutants - environmental risk factors for diabetes mellitus? - A case control 146 Emergency data-based syndromic surveillance in India study

Principal Investigator Funded by Principal Investigator Funded by Dr. R Sankaran ICMR under ICMR-University of Minnesota Dr. G V Ramana Rao ICMR under Indo-German Programme (UoM), USA MoU Director, Executive Partner, PSG Institute of Medical Sciences and GVK Emergency Management and Research, Research Institute (EMRI), Devar Off Avanashi Road, Peelamedu, Yamzal, Medchal Road, Date of approval March 8, 2011 Date of approval March 2, 2009 * Coimbatore-641004 Secunderabad-500014 Total budget Rs 25, 60,000 Total budget Rs 4, 00,000 Duration 36 Months Duration 18 Months Subject area Diabetes Subject area Other Infectious Diseases

144 Development of chimeric genetic vaccine against Human Papillomavirus type 16 147 Molecular and phenotypic characterization of virulence and resistance determinants in hospital and community acquired isolates of Staphylococcus aureus from Chennai, South India

Principal Investigator Funded by Principal Investigator Funded by Dr. Mausumi Bhardwaj ICMR under Indo-German Programme Dr. Padma Krishnan ICMR under Indo-German Programme Scientist E, Lecturer, Institute of Cytology and Preventive Dr. ALM Post-Graduate Institute of Oncology (ICPO), 1-7, Sector-39, Basic Medical Sciences, University of Near Degree College, Madras, Taramani, Date of approval June 23, 2008 * Date of approval March 2, 2009* * NOIDA-201301 Chennai-600113 Total budget Rs 33, 33,600 Total budget Rs 25, 88,000 Duration 36 Months Duration 24 Months Subject area Oncology Subject area Bacteriology

* The extension for one year with additional funds of Rs.10, 04,800 was endorsed in HMSC meeting held on * Change of PI from Dr. Anil Jampala to Dr. G V Ramana Rao endorsed in HMSC meeting held on March September 10, 2012 8, 2011 ** Extension for one year with additional funds of Rs 13, 62,724 endorsed in HMSC meeting held on March 12, 2012

Indian Council of Medical Research 77 Indian Council of Medical Research 78

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S.no. Detail of Projects

148 Molecular epidemiology of Group A streptococcus in North India: Identification of region- specific vaccine candidates

Principal Investigator Funded by Dr. Atul Kumar Johri ICMR under Indo-German Programme Assistant Professor, Jawaharlal Nehru University, New Mehrauli Road, New Delhi-110067 Date of approval March 2, 2009 * Total budget Rs 18, 41,840 Duration 24 Months Subject area Cardiovascular Diseases

149 Structure- fuction relationship in a circularly permuted GTPase from Mycobacterium tuberculosis for the development of novel anti- bacterial drug targets

Principal Investigator Funded by Dr. Balaji Prakash ICMR under Indo-German Programme Associate Professor, Indian Institute of Technology (Kanpur), Kalyanpur, Kanpur-208016 Date of approval March 2, 2009 Total budget Rs 23, 51,490 Duration 24 Months Subject area Tuberculosis

150 Genome wide reconstruction and analysis of Bacillus anthracis metabolic network and its transcriptional regulation

Principal Investigator Funded by Dr. Rakesh Bhatnagar ICMR under Indo-German Programme Professor, Jawaharlal Nehru University, New Mehrauli Road, New Delhi-110067 Date of approval June 8, 2009 Total budget Rs 29, 91,600 Duration 24 Months Subject area Genomics

* Approved for JNU, New Delhi only

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151 Investigations on the therapeutic potential applications of PSA mimetics in cell culture and mouse models of brain injury and disease

Principal Investigator Funded by Dr. Gurcharan Kaur ICMR under Indo-German Programme Professor, Guru Nanak Dev University, G. T Road, National Highway, Amritsar-143005 Date of approval December 8, 2010 Total budget Rs 52, 78,000 Duration 24 Months Subject area Neurosciences

152 Molecular pathogenesis of streptococcal edocarditis

Principal Investigator Funded by Dr. Thangam Menon ICMR under Indo-German Programme Professor & Head, Dr. ALM Post-Graduate Institute of Basic Medical Sciences, University of Madras, Taramani, Date of approval December 8, 2010 * Chennai-600113 Total budget Rs 30, 88,087 Duration 24 Months Subject area Bacteriology

153 Study of immunological determinants at the lesional site of patients with Post kala-azar dermal Leishmaniasis

Principal Investigator Funded by Dr. Mitali Chatterjee ICMR under Indo-German Programme Associate Professor, Institute of Post Graduate Medical Education and Research (IPGMER), 244 B, Acharya Jagadish Chandra Date of approval December 8, 2010 ** Bose Road, Kolkata-700020 Total budget Rs 10, 01,000 Duration 24 Months Subject area Leishmaniasis

* Extension of the project for three months endorsed in HMSC meeting held on March 8, 2013 ** Approved with condition

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154 Studies on the antibiotic and heavy metal resistance of some bacterial strains, obtained from natural environments of Germany and India

Principal Investigator Funded by Dr. M K Chattopadhyay ICMR under Indo-German Programme Scientist E II, Center for Cellular and Molecular Biology, Uppal Road, Hyderabad-500007 Date of approval December 8, 2010* Total budget Rs 1, 15,000 Duration 12 Months Subject area Bacteriology

155 Virulence profiling of Listeria monocytogenes isolated from food, veterinary and clinical sources

Principal Investigator Funded by Dr. D R Kalorey ICMR under Indo-German Programme Professor & Head, Nagpur Veterinary College, Seminary Hills, High Land Drive, Nagpur-440006 Date of approval December 8, 2010 ** Total budget Rs 10, 44,000 Duration 24 Months Subject area Bacteriology

156 Nano-carriers for intra-cutaneous targeting in management of skin cancer & skin diseases

Principal Investigator Funded by Dr. M S Nagarsenker ICMR under Indo-German Programme Professor & Head, Bombay College of Pharmacy, Sunder Nagar, Kalina, Santacruz (E), Mumbai-400098 Date of approval March 8, 2011 Total budget Rs 10, 67, 000 Duration 24 Months Subject area Oncology

* Project not initiated since not sanctioned from German side ** Approved with conditions

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157 Validation of PARF peptide from streptococci as a marker for acute rheumatic fever and rheumatic heart disease

Principal Investigator Funded by Dr. Rajesh Kumar ICMR under Indo-German Programme Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval March 8, 2011 * Chandigarh-160012 Total budget Rs 37, 53, 818 Duration 24 Months Subject area Cardiovascular Diseases

158 Environmental predictors of water safety and enteric infections in vulnerable populations

Principal Investigator Funded by Dr. Vinohar Balraj ICMR under Indo-US Joint Statement (Environmental & Occupational Health) Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore- 632004 Date of approval March 2, 2009 Total budget Rs 30, 00,850 Duration 24 Months Subject area Environmental Health

159 Mechanistic analysis of cadmium-induced cardiovascular disease

Principal Investigator Funded by Dr. Suvro Chatterjee ICMR under Indo-US Joint Statement (Environmental & Occupational Health) Faculty Scientist, Madras Institute of Technology (MIT), Anna University, Chennai-600044 Date of approval March 2, 2009 * Total budget Rs 29, 95,300 Duration 36 Months Subject area Environmental Health

* Approved with conditions

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160 Reducing pesticide toxicity in exposed population of Punjab by targeting NRF2 pathway

Principal Investigator Funded by Dr. J S Thakur ICMR under Indo-US Joint Statement (Environmental & Occupational Health) Associate Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval March 2, 2009 * Chandigarh-160012 Total budget Rs 29, 95,000 Duration 18 Months Subject area Environmental Health

161 Economic evaluation of interventions to prevent manual material handling injuries in the informal labour sector

Principal Investigator Funded by Dr. Somnath Gangopadhyay ICMR under Indo-US Joint Statement (Environmental & Occupational Health) Reader, University College of Science and Technology, Senate House, 87 /1 College Street, Date of approval June 8, 2009 Kolkata-700073 Total budget Rs 25, 94, 500 Duration 36 Months Subject area Environmental Health

162 Comparative genomic hybridization and mitochip array analysis of individuals with and without arsenic induced skin lesions

Principal Investigator Funded by Dr. Ashok Giri ICMR under Indo-US Joint Statement (Environmental & Occupational Health) Deputy Director, Indian Institute of Chemical Biology, 4, Raja S C Mullick Road, Kolkata-100032 Date of approval March 8, 2011 Total budget Rs 15, 17, 000 Duration 12 Months Subject area Environmental Health

* Approved with conditions

83

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S.no. Detail of Projects S.no. Detail of Projects

160 Reducing pesticide toxicity in exposed population of Punjab by targeting NRF2 pathway 163 Effect of indoor air pollution on women and children in India

Principal Investigator Funded by Principal Investigator Funded by Dr. J S Thakur ICMR under Indo-US Joint Statement Dr. Rekha Kashyap ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Associate Professor, Scientist E, Post Graduate Institute of Medical National Institute of Occupational Education and Research (PGIMER), Health (NIOH), Meghani Nagar, Sector 12-D, Ahmedabad-380016 Date of approval March 2, 2009 * Date of approval March 8, 2011 Chandigarh-160012 Total budget Rs 29, 95,000 Total budget Rs 77, 58, 400 Duration 18 Months Duration 48 Months Subject area Environmental Health Subject area Environmental Health

161 Economic evaluation of interventions to prevent manual material handling injuries in the informal 164 Exposure on household air pollution in central and northern India: Assessing the benefits from labour sector improved biomass cook-stoves

Principal Investigator Funded by Principal Investigator Funded by Dr. Somnath Gangopadhyay ICMR under Indo-US Joint Statement Dr. Kalpana Balakrishnan ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Reader, Professor & Head, University College of Science and Sri Ramachandra University, Technology, Senate House, No.1 Ramachandra Nagar, Porur, 87 /1 College Street, Chennai-600116 Date of approval June 8, 2009 Date of approval March 8, 2011 Kolkata-700073 Total budget Rs 25, 94, 500 Total budget Rs 1, 07, 31,594 Duration 36 Months Duration 48 Months Subject area Environmental Health Subject area Environmental Health

162 Comparative genomic hybridization and mitochip array analysis of individuals with and without 165 Potential role of biomarkers and gene-environment interactions in subject population exposed to arsenic induced skin lesions indoor air pollution

Principal Investigator Funded by Principal Investigator Funded by Dr. Ashok Giri ICMR under Indo-US Joint Statement Dr. Veena Dhawan ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Deputy Director, Professor, Indian Institute of Chemical Biology, Post Graduate Institute of Medical 4, Raja S C Mullick Road, Education and Research (PGIMER), Kolkata-100032 Sector 12-D, Date of approval March 8, 2011 Date of approval March 8, 2011 Chandigarh-160012 Total budget Rs 15, 17, 000 Total budget Rs 3, 97, 53,016 Duration 12 Months Duration 48 Months Subject area Environmental Health Subject area Environmental Health

* Approved with conditions

Indian Council of Medical Research 83 Indian Council of Medical Research 84

Research Projects Approved by HMSC Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

166 Randomized controlled trial to assess the effectiveness of an improved stove in reducing 169 Indoor air pollution and asthma exacerbation in children: A population based study household indoor air pollution and its impact on low birth weight and morbidity in young infants

Principal Investigator Funded by Principal Investigator Funded by Dr. Archana Patel ICMR under Indo-US Joint Statement Dr. Raj Kumar ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Professor & Head, Head, Lata Medical Research Foundation, Vallabhbhai Patel Chest Institute, Kinkine Kutir, Vasant Nagar Colony University of Delhi, Guru Tegh Near Deeksha Bhoomi Square, Bahadur Rd, Date of approval March 8, 2011 * Date of approval December 8, 2011 Nagpur-440022 New Delhi-110007 Total budget Rs 3, 76, 25, 485 Total budget Rs 2, 20, 69, 190 Duration 42 Months Duration 36 Months Subject area Environmental Health Subject area Environmental Health

167 Impact of indoor air pollution on respiratory health: A population based adult cohort study 170 Identification and validation of early biomarkers for predicting toxicity including precarciniogenic lesions in individuals occupationally exposed to Polycyclic Aromatic Hydrocarbons (PAHs) and through tobacco use

Principal Investigator Funded by Principal Investigator Funded by Dr. Surinder K Jindal ICMR under Indo-US Joint Statement Dr. Devendra Parmer ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Professor, Deputy Director, Post Graduate Institute of Medical Indian Institute of Toxicology Research Education and Research (PGIMER), (A constituent laboratory of Council of Sector 12-D, Scientific and Industrial Research), Date of approval June 8, 2011 Date of approval March 12, 2012 Chandigarh-160012 M G Marg, Total budget Rs 1, 95, 04, 000 Lucknow-226001 Total budget Rs 85, 15, 040 Duration 48 Months Duration 36 Months Subject area Environmental Health Subject area Environmental Health

168 Magnitude and impact of indoor air pollution on morbidity related to chronic obstructive 171 Autophagy as a mechanism of innate immunity against HIV: postnatal development and pulmonary disease and bronchial asthma in Indian women regulation by C-Tat vs. B-Tat

Principal Investigator Funded by Principal Investigator Funded by Dr. Ashutosh N Aggarwal ICMR under Indo-US Joint Statement Dr. Udaykumar Ranga ICMR & DBT under Indo-US Joint Statement (Environmental & Occupational Health) (HIV/AIDS & STD Prevention) Professor, Associate Professor, Post Graduate Institute of Medical Jawaharlal Nehru Centre for Advance Education and Research (PGIMER), Science Research (JNCASR), Sector 12-D, Jakkur (PO), Date of approval June 8, 2011 Date of approval June 8, 2011 * Chandigarh-160012 Bangalore-560064 Total budget Rs 1, 26, 76,000 Total budget Rs 21, 84,000 Duration 48 Months Duration 24 Months Subject area Environmental Health Subject area HIV/AIDS/ STD

Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Approved with condition *

85 Indian Council of Medical Research 86

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S.no. Detail of Projects S.no. Detail of Projects

166 Randomized controlled trial to assess the effectiveness of an improved stove in reducing 169 Indoor air pollution and asthma exacerbation in children: A population based study household indoor air pollution and its impact on low birth weight and morbidity in young infants

Principal Investigator Funded by Principal Investigator Funded by Dr. Archana Patel ICMR under Indo-US Joint Statement Dr. Raj Kumar ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Professor & Head, Head, Lata Medical Research Foundation, Vallabhbhai Patel Chest Institute, Kinkine Kutir, Vasant Nagar Colony University of Delhi, Guru Tegh Near Deeksha Bhoomi Square, Bahadur Rd, Date of approval March 8, 2011 * Date of approval December 8, 2011 Nagpur-440022 New Delhi-110007 Total budget Rs 3, 76, 25, 485 Total budget Rs 2, 20, 69, 190 Duration 42 Months Duration 36 Months Subject area Environmental Health Subject area Environmental Health

167 Impact of indoor air pollution on respiratory health: A population based adult cohort study 170 Identification and validation of early biomarkers for predicting toxicity including precarciniogenic lesions in individuals occupationally exposed to Polycyclic Aromatic Hydrocarbons (PAHs) and through tobacco use

Principal Investigator Funded by Principal Investigator Funded by Dr. Surinder K Jindal ICMR under Indo-US Joint Statement Dr. Devendra Parmer ICMR under Indo-US Joint Statement (Environmental & Occupational Health) (Environmental & Occupational Health) Professor, Deputy Director, Post Graduate Institute of Medical Indian Institute of Toxicology Research Education and Research (PGIMER), (A constituent laboratory of Council of Sector 12-D, Scientific and Industrial Research), Date of approval June 8, 2011 Date of approval March 12, 2012 Chandigarh-160012 M G Marg, Total budget Rs 1, 95, 04, 000 Lucknow-226001 Total budget Rs 85, 15, 040 Duration 48 Months Duration 36 Months Subject area Environmental Health Subject area Environmental Health

168 Magnitude and impact of indoor air pollution on morbidity related to chronic obstructive 171 Autophagy as a mechanism of innate immunity against HIV: postnatal development and pulmonary disease and bronchial asthma in Indian women regulation by C-Tat vs. B-Tat

Principal Investigator Funded by Principal Investigator Funded by Dr. Ashutosh N Aggarwal ICMR under Indo-US Joint Statement Dr. Udaykumar Ranga ICMR & DBT under Indo-US Joint Statement (Environmental & Occupational Health) (HIV/AIDS & STD Prevention) Professor, Associate Professor, Post Graduate Institute of Medical Jawaharlal Nehru Centre for Advance Education and Research (PGIMER), Science Research (JNCASR), Sector 12-D, Jakkur (PO), Date of approval June 8, 2011 Date of approval June 8, 2011 * Chandigarh-160012 Bangalore-560064 Total budget Rs 1, 26, 76,000 Total budget Rs 21, 84,000 Duration 48 Months Duration 24 Months Subject area Environmental Health Subject area HIV/AIDS/ STD

Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Approved with condition *

Indian Council of Medical Research 85 86

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172 Consequences of HIV-1 and JC virus co-infection in human neural precursor cells: Implications in neuroAIDS patients

Principal Investigator Funded by Dr. Pankaj Seth ICMR & DBT under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Additional Professor, National Brain Research Center, NH-8, Nainwat road, Manesar, Gurgaon-122050 Date of approval June 8, 2011 * Total budget Rs 37, 29,680 Duration 24 Months Subject area HIV/AIDS/ STD

173 Determinants of HIV-1 male to female sexual transmission: Effects of herpesvirus on semen mediated HIV-1 transmission to cervico vaginal tissues ex-vivo

Principal Investigator Funded by Dr. Sarman Singh ICMR & DBT under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval June 8, 2011 ** Total budget Rs 46, 19,059 Duration 24 Months Subject area HIV/AIDS/ STD

174 An accurate point of care diagnostic for HIV detection without follow up

Principal Investigator Funded by Dr. Vaijayyanti Kumar ICMR & DBT under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Scientist F, National Chemical Laboratory, Dr Homi Bhabha Road, Pune-411008 Date of approval September 8, 2011 Total budget Rs 49, 75,000 Duration 24 Months Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention ** Approved with suggestions

Indian Council of Medical Research 87

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172 Consequences of HIV-1 and JC virus co-infection in human neural precursor cells: Implications in 175 Improving cervical cancer prevention among HIV-infected women using novel HPV based neuroAIDS patients biomarker assays

Principal Investigator Funded by Principal Investigator Funded by Dr. Pankaj Seth ICMR & DBT under Indo-US Joint Statement Dr. Sanjay Mehendale ICMR & DBT under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Additional Professor, Scientist G & Director, National Brain Research Center, National Institute of Epidemiology, R- NH-8, Nainwat road, Manesar, 127, 3rd Avenue, Tamil Nadu Housing Gurgaon-122050 * Board, Ayapakkam, Date of approval June 8, 2011 Date of approval September 8, 2011 Chennai-600077 Total budget Rs 37, 29,680 Total budget Rs 63, 25,426 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

173 Determinants of HIV-1 male to female sexual transmission: Effects of herpesvirus on semen 176 Rapid screening of pathogens in patient's sera by novel nano biosensors mediated HIV-1 transmission to cervico vaginal tissues ex-vivo

Principal Investigator Funded by Principal Investigator Funded by Dr. Sarman Singh ICMR & DBT under Indo-US Joint Statement Dr. K P Singh ICMR & DBT under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Head, Professor, All India Institute of Medical Sciences G B Pant University of Agiculture and (AIIMS), Ansari Nagar, Technology, New Delhi-110029 Pant Nagar-263145 Date of approval June 8, 2011 ** Date of approval September 8, 2011 Total budget Rs 46, 19,059 Total budget Rs 49, 95,000 * Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

174 An accurate point of care diagnostic for HIV detection without follow up 177 Evaluation of efficacy of a polyherbal (Basant) and anti-HIV vaginal microbicide in humanized mouse model and its mode of action

Principal Investigator Funded by Principal Investigator Funded by Dr. Vaijayyanti Kumar ICMR & DBT under Indo-US Joint Statement Dr. Smita S Kulkarni ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Scientist F, Scientist D, National Chemical Laboratory, National AIDS Research Institute Dr Homi Bhabha Road, (NARI), 73 G Block, MIDC, Bhosari, Pune-411008 Post Box No. 1875, Date of approval September 8, 2011 Date of approval December 22, 2008 ** Pune-411026 Total budget Rs 49, 75,000 Total budget Rs 52, 53,360 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Funded by DBT ** Approved with suggestions ** Extension approved in HMSC meeting held on December 10, 2012 without additional funds for two months

Indian Council of Medical Research 87 88

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178 Curcumin: A multi mechanism HIV microbicide

Principal Investigator Funded by Dr. Anand K Kondapi ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Professor, University of Hyderabad, Prof. C. R. Road, Gachibowli, Hyderabad-500046 Date of approval December 22, 2008 Total budget Rs 38, 35,720 Duration 24 Months Subject area HIV/AIDS/ STD

179 Assessing willingness to participate and methods for improving adherence and self-reporting among high risk women in India: A simulated microbicide trial

Principal Investigator Funded by Dr. Suniti Solomon ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Director, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 22, 2008 Chennai-600113 Total budget Rs 33, 00,000 Duration 24 Months Subject area HIV/AIDS/ STD

180 Social/sexual networks of high risk married MSM in Mumbai

Principal Investigator Funded by Dr. Raman Gangakhedkar ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Scientist E, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval March 2, 2009 Pune-411026 Total budget Rs 13, 00,863 Duration 24 Months Subject area HIV/AIDS/ STD

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181 Enhancing HIV risk reduction among Indian women with risky husbands (Raising HIV Awareness among Non-Infected Indian (RHANI) Wives: HIV Risk Reduction Intervention for at Risk Wives in India) Principal Investigator Funded by Dr. Balaiah Donta ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Scientist F , National Institute of Research in Reproductive Health (NIRRH), Jehangir Merwanji Street, Parel, Date of approval March 2, 2009 Mumbai-400012 Total budget Rs 67, 73,932 Duration 24 Months Subject area HIV/AIDS/ STD

182 Addressing psychosocial needs and HIV risk in Indian MSM

Principal Investigator Funded by Dr. Beena E Thomas ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Scientist B, National Institute for Research in Tuberculosis (NIRT), Mayor V.R. Ramanathan Road, Chetput, Date of approval March 2, 2009 Chennai-600031 Total budget Rs 23, 95,490 Duration 24 Months Subject area HIV/AIDS/ STD

183 Determine immune based interventions that can enhance NK cell & T cell functions in HIV+ persons with TB

Principal Investigator Funded by Dr. Vijaya Lakshmi Valluri ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Group Leader, LEPRA Society, Blue Peter Research Center, Near TEC Building, Cherlapally, Date of approval June 8, 2011 Hyderabad-501301 Total budget Rs 50, 00, 000 Duration 24 Months Subject area HIV/ Tuberculosis

Indian Council of Medical Research 90

Research Projects Approved by HMSC Research Projects Approved by HMSC

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184 Incidence of HIV among Indian men who have sex with men

Principal Investigator Funded by Dr. Dilip Mathai ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Head, Christian Medical College & Hospital, Ida Scudder Road, Vellore- 632004 Date of approval June 8, 2011 Total budget Rs 80, 04, 363 Duration 24 Months Subject area HIV/AIDS/ STD

185 Mental health, substance use and violence: Effectiveness of a mental health intervention to reduce HIV risk behaviors in female sex workers in Bangalore

Principal Investigator Funded by Dr. Prabha S Chandra ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Professor, National Institute of Mental Health & Neuro Sciences (NIMHANS), Bangalore-560029 Date of approval June 8, 2011 * Total budget Rs 26, 77,920 Duration 24 Months Subject area HIV/AIDS/ STD

186 Molecular mechanisms & therapy for cocaine abuse in HIV Associated Neuro-cognitive Disorder (HAND)

Principal Investigator Funded by Dr. Pankaj Seth ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Additional Professor, National Brain Research Center, NH-8 Nainwal Road, Manesar, Gurgaon-122051 Date of approval June 8, 2011 Total budget Rs 35, 67,600 Duration 24 Months Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention

Indian Council of Medical Research 91

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S.no. Detail of Projects S.no. Detail of Projects

184 Incidence of HIV among Indian men who have sex with men 187 HIV prevention via mobile phones among male sex workers in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Dilip Mathai ICMR under Indo-US Joint Statement Dr. Beena E Thomas ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Head, Scientist B, Christian Medical College & Hospital, National Institute for Research in Ida Scudder Road, Tuberculosis (NIRT), Mayor V.R. Vellore- 632004 Ramanathan Road, Chetput, Date of approval June 8, 2011 Date of approval September 8, 2011* Chennai-600031 S Total budget Rs 80, 04, 363 Total budget Rs 30, 62,468 e Duration 24 Months Duration 24 Months pt e Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD m b 185 Mental health, substance use and violence: Effectiveness of a mental health intervention to reduce 188 HIV, intestinal microbiota and ART er HIV risk behaviors in female sex workers in Bangalore 8, 2 0 Principal Investigator Funded by Principal Investigator Funded by 1 Dr. Prabha S Chandra ICMR under Indo-US Joint Statement Dr. Rita Isaac ICMR under Indo-US Joint Statement 1 (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) * Professor, Professor, National Institute of Mental Health & Christian Medical College & Hospital, Neuro Sciences (NIMHANS), Ida Scudder Road, Bangalore-560029 Vellore-632004 Date of approval June 8, 2011 * Date of approval September 8, 2011 Total budget Rs 26, 77,920 Total budget Rs 56, 56,000 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

186 Molecular mechanisms & therapy for cocaine abuse in HIV Associated Neuro-cognitive Disorder 189 HPV related neoplasia among HIV seropositive Indian men who have sex with men (HAND)

Principal Investigator Funded by Principal Investigator Funded by Dr. Pankaj Seth ICMR under Indo-US Joint Statement Dr. Dilip Mathai ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Additional Professor, Head, National Brain Research Center, Christian Medical College & Hospital, NH-8 Nainwal Road, Manesar, Ida Scudder Road, Gurgaon-122051 Vellore-632004 Date of approval June 8, 2011 Date of approval September 8, 2011 Total budget Rs 35, 67,600 Total budget Rs 78, 25,066 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Approved with suggestions

Indian Council of Medical Research 91 Indian Council of Medical Research 92

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

190 Internet-based HIV prevention for Indian MSM

Principal Investigator Funded by Dr. Asha Banu Soletti ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Associate Professor, Tata Institute of Social Sciences, Post Box-8313, Sion-Trombay Road, Date of approval September 8, 2011 Mumbai-400088 Total budget Rs 25, 00,000 Duration 24 Months Subject area HIV/AIDS/ STD

191 Rapid diagnosis of early TB in HIV+patients

Principal Investigator Funded by Dr. Indu Verma ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Additional Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval September 8, 2011 Chandigarh-160012 Total budget Rs 59, 71,528 Duration 24 Months Subject area HIV/ Tuberculosis

192 SHAKTI: Stigma reduction, Health care provider Awareness and Knowledge enhancement on Transgender Issues in India

Principal Investigator Funded by Dr. Hemangi Jerajani ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Professor & Head, LTMG Hospital & LTM Medical College, Sion, Mumbai-400022 Date of approval September 8, 2011 * Total budget Rs 22, 63,675 Duration 24 Months Subject area HIV/AIDS/ STD

* Approved with suggestions

93

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

190 Internet-based HIV prevention for Indian MSM 193 The role of Vitamin D in the prevention of Mtb disease in HIV-infected individual

Principal Investigator Funded by Principal Investigator Funded by Dr. Asha Banu Soletti ICMR under Indo-US Joint Statement Dr. Sanjeev Sinha ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Associate Professor, Associate Professor, Tata Institute of Social Sciences, ,All India Institute of Medical Sciences Post Box-8313, (AIIMS), Ansari Nagar, Sion-Trombay Road, New Delhi-110029 Date of approval September 8, 2011 Date of approval September 8, 2011 * Mumbai-400088 Total budget Rs 25, 00,000 Total budget Rs 48, 48,656 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/ Tuberculosis

191 Rapid diagnosis of early TB in HIV+patients 194 Mobile phone adherence and prevention support for people living with HIV in India( revised titile : ART Adherence behavior and practices among HIV positive in Kolkata, India )

Principal Investigator Funded by Principal Investigator Funded by Dr. Indu Verma ICMR under Indo-US Joint Statement Dr. Smarajit Jana ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Additional Professor, Chief Technical Advisor, Post Graduate Institute of Medical Durbar Mahila Samanwaya Committee Education and Research (PGIMER), (DMSC), 44 Balaram Dey Street, Sector 12-D, Kolkata-700006 Date of approval September 8, 2011 Date of approval March 12, 2012 Chandigarh-160012 Total budget Rs 59, 71,528 Total budget Rs 46, 07,238 Duration 24 Months Duration 24 Months Subject area HIV/ Tuberculosis Subject area HIV/AIDS/ STD

192 SHAKTI: Stigma reduction, Health care provider Awareness and Knowledge enhancement on 195 Alcohol, sexual risk and adherence in public and private ART centers in India Transgender Issues in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Hemangi Jerajani ICMR under Indo-US Joint Statement Dr. Vinay Kulkarni ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Professor & Head, Coordinator, LTMG Hospital & LTM Medical Amrita Clinic, College, Sion, Athawale Corner Building, Mumbai-400022 Near Sambhaji Bridge, Date of approval September 8, 2011 * Date of approval December 10, 2012* Karve Road, Total budget Rs 22, 63,675 Pune-411004 Total budget Rs 49, 99, 718 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Approved with suggestions * Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention

Indian Council of Medical Research 93 94

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

196 Cervical cancer patient navigation among women living with HIV in Surat, India

Principal Investigator Funded by Dr. J K Kosambiya ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Professor, Govt. Medical College, Majura Gate, Surat-395001 Date of approval December 10, 2012 * Total budget Rs 38, 16, 590 Duration 24 Months Subject area HIV/AIDS/ STD

197 Development of maturation inhibitors as a globally effective class of antiretrovirals

Principal Investigator Funded by Dr. Ritu Gaur ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Associate Professor, South Asian University, Akbar Bhawan, Chanakyapuri, New Delhi-110021 Date of approval December 10, 2012 Total budget Rs 50, 00, 000 Duration 24 Months Subject area HIV/AIDS/ STD

198 Development of novel targeted nano – therapeutics against HIV – 1

Principal Investigator Funded by Prof. Rinti Banerjee ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Professor, Indian Institute of Technology- Bombay, Mumbai, Powai, Mumbai-400076 Date of approval December 10, 2012 ** Total budget Rs 82, 88, 000 Duration 24 Months Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention ** Approved with condition

Indian Council of Medical Research 95

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

196 Cervical cancer patient navigation among women living with HIV in Surat, India 199 HIV drug resistance monitoring in Chennai, India

Principal Investigator Funded by Principal Investigator Funded by Dr. J K Kosambiya ICMR under Indo-US Joint Statement Dr. S Saravanan ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Professor, Assistant Professor, Govt. Medical College, Y R Gaitonde Centre for AIDS Majura Gate, Research and Education (YRG CARE), Surat-395001 Voluntary Health Services, Taramani, Date of approval December 10, 2012 * Date of approval December 10, 2012 * Chennai-600113 Total budget Rs 38, 16, 590 Total budget Rs 49, 98, 454 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

197 Development of maturation inhibitors as a globally effective class of antiretrovirals 200 Identification of immunogenetic factors that regulate the risk of HIV / AIDS: A comparative study of Indian and American populations

Principal Investigator Funded by Principal Investigator Funded by Dr. Ritu Gaur ICMR under Indo-US Joint Statement Prof. Narinder K Mehra ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Associate Professor, Professor & Head, South Asian University, All India Institute of Medical Sciences Akbar Bhawan, Chanakyapuri, (AIIMS), Ansari Nagar, New Delhi-110021 New Delhi-110029 Date of approval December 10, 2012 Date of approval December 10, 2012 Total budget Rs 50, 00, 000 Total budget Rs 49, 83, 225 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

198 Development of novel targeted nano – therapeutics against HIV – 1 201 Implementing DRISHTI: Reducing HIV risk among sex workers with depression

Principal Investigator Funded by Principal Investigator Funded by Prof. Rinti Banerjee ICMR under Indo-US Joint Statement Dr. Smarajit Jana ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Professor, Chief Technical Advisor, Indian Institute of Technology- Bombay, Durbar Mahila Samanwaya Committee Mumbai, Powai, (DMSC), 44 Balaram Dey Street, Mumbai-400076 Kolkata-700006 Date of approval December 10, 2012 ** Date of approval December 10, 2012 ** Total budget Rs 82, 88, 000 Total budget Rs 55, 72,157 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Approved with condition ** Approved with condition ** Conditional approval granted only for formative part of the study for one year

Indian Council of Medical Research 95 96

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

202 MicroRNAs as markers of disease and pathogenesis in HIV / TB co-infection

Principal Investigator Funded by Dr. Shahid Jameel ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Group Leader, International Centre for Genetic Engineering and Biotechnology, Aruna Asaf Ali Marg, Date of approval December 10, 2012 * New Delhi-110067 Total budget Rs 50, 39, 000 Duration 24 Months Subject area HIV/Tuberculosis

203 Multi-level intervention among HIV-positive men who have sex with men (MSM) in India

Principal Investigator Funded by Dr. Venkatesan Chakrapani ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Director, Centre for Sexuality and Health Research and Policy (C-SHaRP), 38 (Old No.167), Date of approval December 10, 2012 ** Rangarajapuram Main Road, Kodambakkam, Total budget Rs 56, 95,440 Chennai-600024 Duration 24 Months Subject area HIV/AIDS/ STD

204 Pathobiology and clinical profile of HIV-associated cancers in India and the West

Principal Investigator Funded by Dr. Aruna Alahari Dhir ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Professor & Head, Tata Memorial Hospital, Tata Memorial Centre, Parel, Mumbai-400012 Date of approval December 10, 2012 ** Total budget Rs 34, 15,000 Duration 24 Months Subject area HIV/AIDS/ STD

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention ** Approved with conditions

Indian Council of Medical Research Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

202 MicroRNAs as markers of disease and pathogenesis in HIV / TB co-infection 205 Rapid detection of human immunodeficiency virus using hand held SERS platform

Principal Investigator Funded by Principal Investigator Funded by Dr. Shahid Jameel ICMR under Indo-US Joint Statement Dr. J P Singh ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Group Leader, Professor, International Centre for Genetic Indian Institute of Technology- New Delhi, Engineering and Biotechnology, Hauz Khas, Aruna Asaf Ali Marg, New Delhi-110016 Date of approval December 10, 2012 * Date of approval December 10, 2012 * New Delhi-110067 Total budget Rs 50, 39, 000 Total budget Rs 48, 91,200 Duration 24 Months Duration 24 Months Subject area HIV/Tuberculosis Subject area HIV/AIDS/ STD

203 Multi-level intervention among HIV-positive men who have sex with men (MSM) in India 206 Role of FOXP3+ regulatory cells in the reactivation of Tuberculosis in HIV – infected persons with LTBI

Principal Investigator Funded by Principal Investigator Funded by Dr. Venkatesan Chakrapani ICMR under Indo-US Joint Statement Dr. Vijaya Lakshmi Valluri ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Director, Group Leader, Centre for Sexuality and Health LEPRA Society, Plot No17, Research and Policy (C-SHaRP), Krishnapuri Colony, West Marredpally, 38 (Old No.167), Secunderabad, Date of approval December 10, 2012 ** Date of approval December 10, 2012 * Rangarajapuram Main Road, Hyderabad-500026 Kodambakkam, Total budget Rs 56, 95,440 Total budget Rs 50, 00,000 Chennai-600024 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/Tuberculosis

204 Pathobiology and clinical profile of HIV-associated cancers in India and the West 207 Role of oxido - reductive stress in regulating HIV - TB co-infection

Principal Investigator Funded by Principal Investigator Funded by Dr. Aruna Alahari Dhir ICMR under Indo-US Joint Statement Dr. Amit Singh ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) (HIV/AIDS & STD Prevention) Professor & Head, Group Leader, Tata Memorial Hospital, International Centre for Genetic Tata Memorial Centre, Parel, Engineering and Biotechnology, Mumbai-400012 Aruna Asaf Ali Marg, Date of approval December 10, 2012 ** Date of approval December 10, 2012 New Delhi-110067 Total budget Rs 34, 15,000 Total budget Rs 54, 00,000 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/Tuberculosis

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention ** Approved with conditions

Indian Council of Medical Research 97 Indian Council of Medical Research 98

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

208 Screening to prevent anal and cervical cancers among HIV infected women in India

Principal Investigator Funded by Dr. Poongulali Selvamuthu ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Medical Officer, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 10, 2012 * Chennai-600113 Total budget Rs 29, 37,450 Duration 24 Months Subject area HIV/AIDS/ STD

209 Studies on the prevalence, risk factors and outcomes of cancers in HIV in India

Principal Investigator Funded by Dr. Sanjeev Sinha ICMR under Indo-US Joint Statement (HIV/AIDS & STD Prevention) Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 10, 2012 Total budget Rs 38, 57,044 Duration 24 Months Subject area HIV/AIDS/ STD

210 Respiratory virus infections: Rapid low cost molecular detection

Principal Investigator Funded by Dr. Shobha Broor ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development Professor, Research) All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 25, 2008** Total budget Rs 32, 14,016 Duration 24 Months Subject area Child Health

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention ** Approved with condition

99

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

208 Screening to prevent anal and cervical cancers among HIV infected women in India 211 Pilot study of newborn screening for haemoglobinopathies in South Gujarat, India

Principal Investigator Funded by Principal Investigator Funded by Dr. Poongulali Selvamuthu ICMR under Indo-US Joint Statement Dr. K Ghosh ICMR under Indo-US Joint Statement (Maternal (HIV/AIDS & STD Prevention) and Child Health & Human Development Medical Officer, Scientist G & Director, Research) Y R Gaitonde Centre for AIDS National Institute of Immunohaematology Research and Education (YRG CARE), (NIIH), 13th Floor, New Multi-storied Voluntary Health Services, Taramani, Building, KEM Hospital Campus, Date of approval December 10, 2012 * Date of approval March 25, 2008 * Chennai-600113 Mumbai-400012 Total budget Rs 29, 37,450 Total budget Rs 55, 08,142 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Child Health

209 Studies on the prevalence, risk factors and outcomes of cancers in HIV in India 212 Probiotics for infectious diarrhea in children in South India

Principal Investigator Funded by Principal Investigator Funded by Dr. Sanjeev Sinha ICMR under Indo-US Joint Statement Dr. Gagandeep Kang ICMR under Indo-US Joint Statement (Maternal (HIV/AIDS & STD Prevention) and Child Health & Human Development Associate Professor, Professor, Research) All India Institute of Medical Sciences Christian Medical College & Hospital, (AIIMS), Ansari Nagar, Ida Scudder Road, New Delhi-110029 Vellore-632004 Date of approval December 10, 2012 Date of approval March 25, 2008 Total budget Rs 38, 57,044 Total budget Rs 1, 11, 60,200 Duration 24 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Child Health

210 Respiratory virus infections: Rapid low cost molecular detection 213 Pilot study of automated surveillance to measure burden rotavirus

Principal Investigator Funded by Principal Investigator Funded by Dr. Shobha Broor ICMR under Indo-US Joint Statement (Maternal Dr. M A Mathew ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development and Child Health & Human Development Professor, Associate Professor, Research) Research) All India Institute of Medical Sciences MOSC Medical College & Hospital, (AIIMS), Ansari Nagar, Kolencherry, New Delhi-110029 Ernakulam-682311 Date of approval March 25, 2008** Date of approval March 25, 2008 Total budget Rs 32, 14,016 Total budget Rs 29, 34,800 Duration 24 Months Duration 24 Months Subject area Child Health Subject area Child Health

* Project not initiated since not approved by Indo-US Joint Working Group of HIV/AIDS & STD Prevention * Extension of 8 months with additional funds of Rs 7, 87,832 endorsed in HMSC meeting held on December 8, 2010 subject to certain conditions ** Approved with condition

Indian Council of Medical Research 99 100

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

214 Congenital Cytomegalovirus (CMV) infection and hearing loss in rural Indian population

Principal Investigator Funded by Dr. Lalit Dar ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development Professor, Research) All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 8, 2009 Total budget Rs 70, 34, 520 Duration 36 Months Subject area Child Health

215 Childhood illness and risk perception: Opportunity to improve hand washing

Principal Investigator Funded by Dr. Temsunaro Rongsen Chandola ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development Scientist, Research) Society for Applied Studies, 45, Kalu Sarai, New Delhi-110016 Date of approval September 8, 2009 * Total budget Rs 53, 44, 560 Duration 24 Months Subject area Child Health

216 Predicting bilirubin - induced auditory toxicity in infants with severe jaundice

Principal Investigator Funded by Dr. Satish Saluja ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development Senior Consultant, Research) Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi-110060 Date of approval September 8, 2009 ** Total budget Rs 42, 43, 492 Duration 24 Months Subject area Child Health

* Project not initiated, reported in HMSC meeting held on March 12, 2012 ** Extension with no additional cost upto August 31, 2012 endorsed in HMSC meeting held on June 18, 2012 and further extension upto March 25, 2013 with no additional funds approved in HMSC meeting held on December 10, 2012

101

ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects

217 Diagnosis of active TB in HIV infected and uninfected young children in India

Principal Investigator Funded by Dr. Renu Bhardwaj ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development Professor & Head, Research) B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval December 8, 2009 * Pune-411001 Total budget Rs 81, 14,273 Duration 12 Months Subject area Child Health

218 Enhancing dietary iron and zinc bioavailability in Indian children

Principal Investigator Funded by Dr. K Madhavan Nair ICMR under Indo-US Joint Statement (Maternal and Child Health & Human Development Secientist E, Research) National Institute of Nutrition (NIN), Jamai Osmania, Tarnaka, Hyderabad-500007 Date of approval December 8, 2009 ** Total budget Rs 26, 00,000 Duration 24 Months Subject area Child Health

219 Biomarkers for transplacental effects and their chemoprevention

Principal Investigator Funded by Dr. Kalpagam Polasa Indo-Bulgarian S&T Programme (with support from DST for exchange visits only) Scientist F & Director, National Institute of Nutrition (NIN), Jamai Osmania, Tarnaka, Hyderabad-500007 Date of approval March 2, 2009 Total budget Rs 55, 25,960 Duration 36 Months Subject area Oncology

* Extension upto August 31, 2012 with additional budget approved in HMSC meeting held on June 18, 2012 and further extension upto March 25, 2013 with additional funds approved in HMSC meeting held on December10, 2012 ** Extension upto August 31, 2012 with no additional budget endorsed in HMSC meeting held on June 18, 2012 and further extension upto March 25, 2013 with no additional funds approved in HMSC meeting held on December10, 2012 Indian Council of Medical Research 102

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

220 HIV vaccine immunogen design: Identification of T-cell epitopes associated with control of viral replication in Indian and South African HIV-1 infected individuals

Principal Investigator Funded by Dr. Ranga Udaykumar Indo-South Africa Joint Programme (DST, New Delhi) Associate Professor, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Jakkur (PO), Date of approval March 8, 2011 * Bangalore-560064 Total budget Rs 1, 35, 00,400 Duration 36 Months Subject area HIV/AIDS/ STD

221 Identification of neutralizing antibody epitopes on India and South African HIV-1 subtype C viruses for HIV vaccine design

Principal Investigator Funded by Dr. Jayanta Bhattacharya Indo-South Africa Joint Programme (DST, New Delhi) Scientist D, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval March 8, 2011* * Pune-411026 Total budget Rs 1, 75, 52,721 Duration 36 Months Subject area HIV/AIDS/ STD

222 Effect of step synchronized vibration on gait of PD patients with electrically stimulated STN

Principal Investigator Funded by Dr. Madhuri Behari Indo-US Science & Technology Forum, New Delhi Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2011 Total budget Rs 92, 73,701 Duration 36 Months Subject area Neurosciences

* Approval for remaining 2 study sites endorsed in HMSC meeting held on June 18, 2012 ** Approved for remaining 2 study sites and transfer of biological material by NARI, Pune in HMSC meeting held on September 8, 2011

103

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

220 HIV vaccine immunogen design: Identification of T-cell epitopes associated with control of viral 223 A phase I double-blind, placebo-controlled, randomized trial to evaluate the safety and replication in Indian and South African HIV-1 infected individuals immunogenicity of TBC-M4, a multigenic MVA HIV vaccine vs. ADV AX, a multigenic DNA HIV vaccine followed by TBC-M4, a multigenic MVA HIV vaccine

Principal Investigator Funded by Principal Investigator Funded by Dr. Ranga Udaykumar Indo-South Africa Joint Programme (DST, New Dr. V D Ramanathan International AIDS Vaccine Initiative (IAVI), Delhi) Scientist F, USA Associate Professor, National Institute for Research in Jawaharlal Nehru Centre for Advanced Tuberculosis (NIRT), Mayor V.R. Scientific Research (JNCASR), Ramanathan Road, Chetput, Jakkur (PO), Date of approval March 8, 2011 * Chennai-600031 Date of approval December 22, 2008 Bangalore-560064 Total budget Rs 1, 35, 00,400 Dr S M Mehandale, Total budget Rs 7, 13, 62,000 Scientist G, Duration 36 Months National AIDS Research Institute (NARI), Duration 36 Months Subject area HIV/AIDS/ STD G-73 Bhosari Industial Estate, Bhosari, Subject area HIV/AIDS/ STD Pune-411026

221 Identification of neutralizing antibody epitopes on India and South African HIV-1 subtype C 224 A comparison of two iron doses on zinc absorption from sprinkles as a micronutrient supplement viruses for HIV vaccine design

Principal Investigator Funded by Principal Investigator Funded by Dr. Jayanta Bhattacharya Indo-South Africa Joint Programme (DST, New Dr. N S Mahantshetti International Atomic Energy Agency (IAEA), Delhi) Austria Scientist D, Vice Principal & Head, National AIDS Research Institute (NARI), Jawaharlal Nehru Medical College, 73 G Block, MIDC, Bhosari, JNMC Campus, Nehru Nagar, Post Box No. 1875, Belgaum-590010 †* Date of approval March 8, 2011* * Date of approval June 8, 2010 Pune-411026 Total budget Rs 1, 75, 52,721 Total budget Rs 6, 82, 990 Duration 36 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Nutrition

222 Effect of step synchronized vibration on gait of PD patients with electrically stimulated STN 225 Stress-rest MIBI-SPECT compared to coronary CT Angiography as the initial test in the evaluation of patients at intermediate risk of coronary events- A pilot randomized controlled trial (IAEA SPECT/CT CAD)

Principal Investigator Funded by Principal Investigator Funded by Dr. Madhuri Behari Indo-US Science & Technology Forum, Dr. G Karthikeyan International Atomic Energy Agency (IAEA), New Delhi Austria Professor, Associate Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval December 8, 2011 Date of approval March 8, 2011** Total budget Rs 92, 73,701 Total budget Rs 8, 07, 520 Duration 36 Months Duration 24 Months Subject area Neurosciences Subject area Cardiovascular Diseases

* Approval for remaining 2 study sites endorsed in HMSC meeting held on June 18, 2012 † Approved for transfer of 10% biological samples only in HMSC meeting held on June 8, 2010 ** Approved for remaining 2 study sites and transfer of biological material by NARI, Pune in HMSC * Request for transfer of all (100%) urine samples to foreign lab for analysis was not recommended in HMSC meeting held on September 8, 2011 meeting held on December 8, 2010 ** Approved with AIIMS only

Indian Council of Medical Research 103 Indian Council of Medical Research 104

Research Projects Approved by HMSC Research ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects

226 A comparison of two iron doses on zinc absorption from sprinkles as a micronutrient supplement

Principal Investigator Funded by Dr. N S Mahantshetti International Atomic Energy Agency (IAEA), Austria Vice Principal & Head, Jawaharlal Nehru Medical College, Date of approval June 8, 2011 * JNMC Campus, Nehru Nagar, Belgaum-590010 *Project at serial no. 224 was placed before HMSC during its meeting held on June 8, 2011 with a request for transfer of 10% of biological samples for analysis and QA/QC purposes, which was approved

227 A randomized phase III study of short course (one-week) radiation therapy versus standard course (three week) radiation therapy in elderly and / or frail patients with newly diagnosed Glioblastoma Multiforme (GBM)

Principal Investigator Funded by Dr. Narendra Kumar International Atomic Energy Agency (IAEA), Austria Assistant Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval September 8, 2011 Chandigarh-160012 Total budget Rs 7, 93, 324 Duration 30 Months Subject area Oncology

228 Zinc and iron bio-availability from bio-fortified pearl millet

Principal Investigator Funded by Dr. Bhalachandra S Kodkany International Atomic Energy Agency (IAEA), Austria and Harvest Plus, Washington DC, USA Professor, Jawaharlal Nehru Medical College, JNMC Campus, Nehru Nagar, Belgaum-590010 Date of approval June 8, 2010 ** Total budget Rs 42, 25, 000 Duration 24 Months Subject area Nutrition

** Approved for transfer of only 40 biological samples to US lab with a suggestion for transfer of technology to Indian lab in HMSC meeting held on September 8, 2010

105

Research Projects Approved by HMSC ResearchResearch Projects Projects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

226 A comparison of two iron doses on zinc absorption from sprinkles as a micronutrient supplement 229 A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone- receptor positive, node positive early stage breast cancer

Principal Investigator Funded by Principal Investigator Funded by Dr. N S Mahantshetti International Atomic Energy Agency (IAEA), Dr. Anusheel Munshi International Breast Cancer Study Group Austria (IBCSG), Switzerland Vice Principal & Head, Professor, Jawaharlal Nehru Medical College, Date of approval June 8, 2011 * Tata Memorial Hospital, JNMC Campus, Nehru Nagar, Tata Memorial Centre, Belgaum-590010 Parel, *Project at serial no. 224 was placed before HMSC Date of approval March 2, 2009* Mumbai-400012 during its meeting held on June 8, 2011 with a Total budget Rs 45, 13, 600 request for transfer of 10% of biological samples for analysis and QA/QC purposes, which was Duration 72 Months approved Subject area Oncology

227 A randomized phase III study of short course (one-week) radiation therapy versus standard course 230 Measurement of chronic disease risk factors in a rural Bangladesh cohort: A pilot collaborative (three week) radiation therapy in elderly and / or frail patients with newly diagnosed Glioblastoma study between ICDDR, B and South Asia Network for Chronic Disease, Public Health Foundation Multiforme (GBM) of India

Principal Investigator Funded by Principal Investigator Funded by Dr. Narendra Kumar International Atomic Energy Agency (IAEA), Prof. Shah Ebrahim International Center for Diarroheal Diseases Austria Research, Bangladesh Assistant Professor, Director, Post Graduate Institute of Medical Public Health Foundation of India, Education and Research (PGIMER), 4/2, Sirifort Institutional Area, Sector 12-D, August Kranti Marg, Date of approval September 8, 2011 Date of approval December 8, 2011 * Chandigarh-160012 New Delhi-110016 Total budget Rs 7, 93, 324 Total budget Not Requested Duration 30 Months Duration 12 Months Subject area Oncology Subject area Diarrhoeal Diseases

228 Zinc and iron bio-availability from bio-fortified pearl millet 231 Chronic Myeloid Leukemia (CML) diagnosis and testing program, under the third iCMLf Emerging Regions Support and Partnership (ERSAP) project

Principal Investigator Funded by Principal Investigator Funded by Dr. Bhalachandra S Kodkany International Atomic Energy Agency (IAEA), Dr. Neelam Verma International Chronic Myeloid Leukemia Austria and Harvest Plus, Washington DC, USA Foundation (iCMLf), Australia Professor, Head, Jawaharlal Nehru Medical College, Post Graduate Institute of Medical JNMC Campus, Nehru Nagar, Education and Research (PGIMER), Sector 12-D, Belgaum-590010 ** Date of approval June 18, 2012 Date of approval June 8, 2010 Chandigarh-160012 Total budget Rs 42, 25, 000 Total budget Rs 5, 00, 000 Duration 24 Months Duration 12 Months Subject area Nutrition Subject area Oncology

** Approved for transfer of only 40 biological samples to US lab with a suggestion for transfer of technology * Approved with conditions to Indian lab in HMSC meeting held on September 8, 2010

Indian Council of Medical Research 105 Indian Council of Medical Research 106

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

232 A prospective, randomized, double-blind, parallel group, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in patients with acute ischemic stroke (DIAS-3)

Principal Investigator Funded by Dr. Rohit Bhatia International Clinical Research, Denmark Additional Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2011 * Total budget Rs 2, 30, 000 Duration 24 Months Subject area Neurosciences

233 Identifying sources, pathways and risk drivers in ecosystems of Japanese Encephalitis in an epidemic prone north Indian district

Principal Investigator Funded by Dr. Manish Kakkar International Development Research Centre, Canada Specialist & Epidemiologist, Public Health Foundation of India, ISID Campus, 4 Institutional Area, Vasant Kunj, Date of approval March 12, 2012* New Delhi-110070 Total budget Rs 1, 84, 16,705 Duration 36 Months Subject area Japanese Encephalitis

234 Prevention of Type 2 diabetes in women with gestational diabetes in urban India - A feasibility study

Principal Investigator Funded by Prof. Nikhil Tondon International Diabetes Federation Brussels, Belgium Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval June 8, 2010** Total budget Rs 32, 44, 500 Duration 24 Months Subject area Diabetes

* Approved with conditions ** Approved for AIIMS, New Delhi only

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

232 A prospective, randomized, double-blind, parallel group, placebo-controlled phase III study to 235 The cross cultural adaptation and clinical affect measurement using assessment scales of low back evaluate the efficacy and safety of desmoteplase in patients with acute ischemic stroke (DIAS-3) pain outcome measures into Hindi

Principal Investigator Funded by Principal Investigator Funded by Dr. Rohit Bhatia International Clinical Research, Denmark Dr. U Singh International Project Development Fund, University of Sydney, Australia Additional Professor, Head, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval March 8, 2011 * Date of approval March 12, 2012 * Total budget Rs 2, 30, 000 Total budget Rs 4, 73, 999 Duration 24 Months Duration 6 Months Subject area Neurosciences Subject area Rehabilitation

233 Identifying sources, pathways and risk drivers in ecosystems of Japanese Encephalitis in an 236 Significance of pattern recognition molecules (toll like receptors) in the neuropathogenesis of epidemic prone north Indian district Japanese Encephalitis

Principal Investigator Funded by Principal Investigator Funded by Dr. Manish Kakkar International Development Research Centre, Dr. R K Ratho International Society for Infectious Diseases, Canada USA Specialist & Epidemiologist, Professor & Head, Public Health Foundation of India, Post Graduate Institute of Medical ISID Campus, 4 Institutional Area, Education and Research (PGIMER), Vasant Kunj, Sector 12-D, Date of approval March 12, 2012* Date of approval March 8, 2011 New Delhi-110070 Chandigarh-160012 Total budget Rs 1, 84, 16,705 Total budget Rs 2,70, 000 Duration 36 Months Duration 12 Months Subject area Japanese Encephalitis Subject area Japanese Encephalitis

234 Prevention of Type 2 diabetes in women with gestational diabetes in urban India - A feasibility 237 Study the prevalence and genetic characterization of Entamoeba histolytica reference strains study

Principal Investigator Funded by Principal Investigator Funded by Prof. Nikhil Tondon International Diabetes Federation Brussels, Dr. Sandipan Ganguly Japan Health Science Foundation, Japan Belgium Professor, Scientist C, All India Institute of Medical Sciences National Institute of Cholera and (AIIMS), Ansari Nagar, Enteric Diseases (NICED), New Delhi-110029 P-33, CIT Road, Scheme XM, Date of approval June 8, 2010** Date of approval December 8, 2009 Beliaghata, Total budget Rs 32, 44, 500 Kolkata-700010 Total budget Rs 15, 00, 000 Duration 24 Months Duration 24 Months Subject area Diabetes Subject area Diarrhoeal Diseases

* Approved with conditions * Approved with conditions ** Approved for AIIMS, New Delhi only

Indian Council of Medical Research 107 108

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

238 Study on the control of cholera and other enteric diseases

Principal Investigator Funded by Dr. G Balakrish Nair Japan International Cooperation Agency (JICA), Japan Scientist G & Director, National Institute of Cholera and Enteric Diseases (NICED), P-33, CIT Road, Scheme XM, Date of approval March 2, 2009 Beliaghata, Kolkata-700010 Total budget Rs 16, 00, 00, 000 Duration 60 Months Subject area Diarrhoeal Diseases

239 Developing an international center for research in emerging viral infections at National Institute of Virology (NIV)

Principal Investigator Funded by Dr. A C Mishra Japan International Cooperation Agency (JICA), Japan Scientist G & Director, National Institute of Virology (NIV), 20-A, Dr.Ambedkar Road, Pune-411001 Date of approval March 8, 2010* Total budget Rs 32, 00, 00, 000 Duration 27 Months Subject area Other Infectious Diseases

240 Chemo to Cure (C to C): Study of cancer survivorship

Principal Investigator Funded by Dr. Rachna Seth Jiv Daya Foundation, Dallas, USA Assistant Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010 Total budget Rs 21, 99, 054 Duration 36 Months Subject area Oncology

* Approved with suggestions

Indian Council of Medical Research 109

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

238 Study on the control of cholera and other enteric diseases 241 YRG CARE matrimonial service

Principal Investigator Funded by Principal Investigator Funded by Dr. G Balakrish Nair Japan International Cooperation Agency (JICA), Dr. Suniti Solomon Johns Hopkins University, USA and Student Japan Field Experience Fund Scientist G & Director, Director, National Institute of Cholera and Y R Gaitonde Centre for AIDS Enteric Diseases (NICED), Research and Education (YRG CARE), P-33, CIT Road, Scheme XM, Voluntary Health Services, Taramani, Date of approval March 2, 2009 Date of approval September 8, 2010 * Beliaghata, Chennai-600113 Kolkata-700010 Total budget Rs 16, 00, 00, 000 Total budget Rs 3, 41, 110 Duration 60 Months Duration 24 Months Subject area Diarrhoeal Diseases Subject area HIV/AIDS/ STD

239 Developing an international center for research in emerging viral infections at National Institute 242 Effective and safe interventions for prevention of malaria in pregnancy in India: An assessment of of Virology (NIV) burden of malaria in pregnancy, implement ability of a screening strategy and barriers to scaling up interventions

Principal Investigator Funded by Principal Investigator Funded by Dr. A C Mishra Japan International Cooperation Agency (JICA), Dr. Neena Valecha Liverpool School of Tropical Medicine, United Japan Kingdom Scientist G & Director, Scientist G & Director, National Institute of Virology (NIV), National Institute of Malaria Research 20-A, Dr.Ambedkar Road, (NIMR), Sector 8, Dwarka, Pune-411001 New Delhi-110077 Date of approval March 8, 2010* Date of approval September 8, 2011 Total budget Rs 32, 00, 00, 000 Total budget Rs 3, 90, 29, 000 Duration 27 Months Duration 36 Months Subject area Other Infectious Diseases Subject area Malaria

240 Chemo to Cure (C to C): Study of cancer survivorship 243 Effective and safe treatment for malaria in pregnancy in India: A randomized controlled trial

Principal Investigator Funded by Principal Investigator Funded by Dr. Rachna Seth Jiv Daya Foundation, Dallas, USA Dr. Neena Valecha Liverpool School of Tropical Medicine, United Kingdom Assistant Professor, Scientist G & Director, All India Institute of Medical Sciences Malaria Research Centre (MRC), (AIIMS), Ansari Nagar, 22, Sham Nath Marg, New Delhi-110029 New Delhi-110054 Date of approval December 8, 2010 Date of approval September 8, 2009 Total budget Rs 21, 99, 054 Total budget Rs 4, 08, 10, 416 Duration 36 Months Duration 60 Months Subject area Oncology Subject area Malaria

* Approved with suggestions * Approved with conditions

Indian Council of Medical Research 109

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

244 Ecosystem dynamics and control of urban malaria in Gujarat State, India

Principal Investigator Funded by Dr. R S Yadav M/s Total Gas and Power, New Delhi (French Oil & Gas Company), India Scientist F & Officer in Charge, National institute of Malaria Research (NIMR), Field Station, Civil Hospital, Date of approval December 22, 2008 Nadiad-387001, Gujarat Total budget Rs 10, 01,183 Duration 60 Months Subject area Malaria

245 Improving the diagnosis of tuberculosis among HIV infected and non-infected individuals in India

Principal Investigator Funded by Dr. Dilip Mathai McGill University, Canada Head, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval December 22, 2008 * Total budget Rs 12,08, 400 Duration 12 Months Subject area HIV/ Tuberculosis

246 HEART OUTCOMES PREVENTION EVALUATION (HOPE)-3 Study of lipid modification and blood pressure reduction in people at average risk for Cardio Vascular Disease (CVD).

Principal Investigator Funded by Dr. Prem Pais McMaster University, Canada Dean & Professor, St. Johns Medical College, St. Johns Research Institute, St. Johns National Academy of Health Date of approval June 23, 2008 ** Sciences, Koramangala, Sarjapur Road, Total budget Rs 9, 65, 25,000 Bangalore-560034 Duration 120 Months Subject area Cardiovascular Diseases

* Approved with conditions ** Approved for including 9 additional sites in HMSC meeting held on March 2, 2009

111

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

244 Ecosystem dynamics and control of urban malaria in Gujarat State, India 247 Burden of drug resistant tuberculosis among HIV - infected patients in metropolitan Mumbai, India

Principal Investigator Funded by Principal Investigator Funded by Dr. R S Yadav M/s Total Gas and Power, New Delhi (French Oil Dr. Srinath Satyanarayana Médecins Sans Frontières, Holland & Gas Company), India Scientist F & Officer in Charge, Operational Research Officer, National institute of Malaria Research The Union, South East Asia Office, (NIMR), C-6, Qutub Institutional Area, Field Station, Civil Hospital, New Delhi-110016 Date of approval December 22, 2008 Date of approval June 18, 2012 Nadiad-387001, Gujarat Total budget Rs 10, 01,183 Total budget Rs 2, 10, 51, 000 Duration 60 Months Duration 15 Months Subject area Malaria Subject area HIV/AIDS/ STD ENOS : Efficacy of Nitric Oxide in Stroke - A prospective, international, multicentre, 245 Improving the diagnosis of tuberculosis among HIV infected and non-infected individuals in India 248 randomized, parallel-group, blinded, controlled, collaborative factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of stopping or continuing prior antihypertensive therapy, in patients with acute stroke Principal Investigator Funded by Principal Investigator Funded by Dr. Dilip Mathai McGill University, Canada Dr. Kameshwar Prasad Medical Research Council, United Kingdom Head, Professor, Christian Medical College & Hospital, All India Institute of Medical Sciences Ida Scudder Road, (AIIMS), Ansari Nagar, Vellore-632004 New Delhi-110029 Date of approval December 22, 2008 * Date of approval March 25, 2008 * Total budget Rs 12,08, 400 Total budget Rs 4, 06, 000 Duration 12 Months Duration 60 Months Subject area HIV/ Tuberculosis Subject area Neurosciences

246 HEART OUTCOMES PREVENTION EVALUATION (HOPE)-3 Study of lipid modification 249 Thrombolysis with intravenous rt-PA for acute ischaemic stroke: the third International Stroke and blood pressure reduction in people at average risk for Cardio Vascular Disease (CVD). Trial (IST-3)

Principal Investigator Funded by Principal Investigator Funded by Dr. Prem Pais McMaster University, Canada Dr. Kameshwar Prasad Medical Research Council, United Kingdom Dean & Professor, Professor, St. Johns Medical College, St. Johns All India Institute of Medical Sciences Research Institute, (AIIMS), Ansari Nagar, St. Johns National Academy of Health New Delhi-110029 Date of approval June 23, 2008 ** Date of approval March 25, 2008 ** Sciences, Koramangala, Sarjapur Road, Total budget Rs 9, 65, 25,000 Total budget Rs 24, 00, 71,680 Bangalore-560034 Duration 120 Months Duration 24 Months Subject area Cardiovascular Diseases Subject area Neurosciences

* Approved with conditions * Inclusion of an additional site, to obtain requisite sample size approved in HMSC meeting held on June 8, ** Approved for including 9 additional sites in HMSC meeting held on March 2, 2009 2009 ** Approved with conditions

Indian Council of Medical Research 111 112

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

250 International study of caesarean section surgical techniques: The follow up study

Principal Investigator Funded by Dr. J B Sharma Medical Research Council, United Kingdom Associate Professor, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi Gate, New Delhi-110002 Date of approval September 8, 2011 Total budget Rs 1, 78, 929 Duration 48 Months Subject area Reproductive Health

251 Evaluation of tolerability and immunogenicity of GARDASIL TM in healthy females, between 16 and 26 years of age, in India

Principal Investigator Funded by Dr. Shalini Fusey Merck & Co., Inc., USA Associate Professor, Government Medical College, Opposite Ramakrishna Mission, Nagpur-440012 Date of approval June 8, 2009 Total budget Rs 1, 20, 00, 000 Duration 48 Months Subject area Oncology

252 The Pan Australasian ChemoTherapy InduCed Emesis burden of illness study (PrACTICE)

Principal Investigator Funded by Dr. Vinod Raina Merck & Co., Inc., USA Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval June 18, 2012 * Total budget Rs 2, 47, 500 Duration 7 Months Subject area Oncology

* Approved for 3 sites only with conditions

113

ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects

253 A phase 3, double-blind, placebo-and active-controlled dose- range- finding efficacy and safety study of preladenant in subjects with early Parkinsons disease

Principal Investigator Funded by Dr. Madhuri Behari Merck & Co., Inc., USA Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 10, 2012 * Total budget Rs 18, 73, 830 Duration 36 Months Subject area Neurosciences

254 Open-label trial to determine the long - term safety of safinamide in Parkinson disease patients

Principal Investigator Funded by Dr. Madhuri Behari Merck Serona S.A., Geneva, Switzerland Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010* * Total budget Rs 57, 76,828 Duration 36 Months Subject area Neurosciences

255 Comprehensive case management pilot programme in Odisha, India

Principal Investigator Funded by Dr. Anupkumar Anvikar Medicines for Malaria Venture (MMV), Switzerland Scientist D, National Institute of Malaria Research (NIMR), Sector 8, Dwarka, New Delhi-110077 Date of approval September 10, 2012 *** Total budget Rs 2, 96, 28,080 Duration 36 Months Subject area Malaria

* Project not initiated, reported to Chairman, HMSC on November 3, 2012 ** Approved for AIIMS, New Delhi only ****** Approved with conditions

Indian Council of Medical Research 114

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

256 MRZ 60201/SP/3001: Prospective double-blind, placebo-controlled, randomized, multi-center study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke spasticity of the upper limb

Principal Investigator Funded by Dr. Madhuri Behari Merz Pharmaceuticals GmbH, Germany Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 10, 2012 * Total budget Rs 25, 21, 996 Duration 24 Months Subject area Neurosciences

257 Innovative strategies to promote early child development among low-income rural infants and preschoolers in India through multiple micronutrient fortification and early learning opportunities

Principal Investigator Funded by Dr. B Sesikeran Micronutrient Initiative, Canada Scientist G & Director, National Institute of Nutrition (NIN), Jamai Osmania, Tarnaka, Hyderabad-500007 Date of approval June 8, 2011 Total budget Rs 1, 69, 74,729 Duration 24 Months Subject area Child Health

258 A randomized, double-blind, placebo-controlled, phase 3 study to assess the efficacy and safety of weekly farletuzumab (MORAb-003) in combination with carboplatin and taxane in subjects with platinum-sensitive ovarian cancer in first relapse Principal Investigator Funded by Dr. Lalit Kumar Morphotek, Inc., USA Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2010* Total budget Rs 13, 09, 091 Duration 65 Months Subject area Oncology

* Approved for AIIMS, New Delhi only

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects A randomized, double-blind, double-dummy, parallel-group multicenter study to demonstrate 256 MRZ 60201/SP/3001: Prospective double-blind, placebo-controlled, randomized, multi-center 259 study with an open-label extension period to investigate the efficacy and safety of NT 201 in the improvement in symptoms of constipation and non-inferiority in analgesic efficacy in subject with treatment of post-stroke spasticity of the upper limb non-malignant or malignant pain that requires around-the-clock opioid therapy taking 50/25 – 80/40 mg twice daily as oxycodone / naloxone prolonged release (OXN PR) tablets compared to Principal Investigator Funded by subject taking 50 – 80 mg twice daily oxycodone prolonged release (OxyPR) tablets alone Dr. Madhuri Behari Merz Pharmaceuticals GmbH, Germany Principal Investigator Funded by Professor, Dr.Sushma Bhatnagar Mundipharma Research, GmbH & Co., Germany All India Institute of Medical Sciences Additional Professor, (AIIMS), Ansari Nagar, All India Institute of Medical Sciences New Delhi-110029 (AIIMS), Ansari Nagar, Date of approval December 10, 2012 * Date of approval December 10, 2012* New Delhi-110029 Total budget Rs 25, 21, 996 Total budget Rs. 23, 13, 216 Duration 24 Months Duration 10 Months Subject area Neurosciences Subject area Oncology

257 Innovative strategies to promote early child development among low-income rural infants and 260 Bowman birk Inhibitor concentrate and oral leukoplakia: A randomized phase IIb trial preschoolers in India through multiple micronutrient fortification and early learning opportunities

Principal Investigator Funded by Principal Investigator Funded by Dr. B Sesikeran Micronutrient Initiative, Canada Dr. Moni Abraham Kuriakose National Cancer Institute, National Institutes of Health, USA Scientist G & Director, Professor, National Institute of Nutrition (NIN), Amrita Institute of Medical Sciences Jamai Osmania, Tarnaka, & Research Institute, Hyderabad-500007 Elamakkara, Date of approval June 8, 2011 Date of approval June 8, 2009 Kochi-682026 Total budget Rs 1, 69, 74,729 Total budget Rs 21, 84, 930 Duration 24 Months Duration 12 Months Subject area Child Health Subject area Oncology

258 A randomized, double-blind, placebo-controlled, phase 3 study to assess the efficacy and safety of 261 A multi-centre randomized, double-blind, placebo controlled clinical trial examining the efficacy weekly farletuzumab (MORAb-003) in combination with carboplatin and taxane in subjects with and safety of low-dose aspirin after initial anticoagulation to prevent recurrent Venous Thrombo- platinum-sensitive ovarian cancer in first relapse Embolism (VTE)

Principal Investigator Funded by Principal Investigator Funded by Dr. Lalit Kumar Morphotek, Inc., USA Dr. Prem Pais National Health and Medical Research Council (NHMRC), Australia Associate Professor, Dean & Professor, All India Institute of Medical Sciences St. Johns Medical College, St. Johns (AIIMS), Ansari Nagar, Research Institute, New Delhi-110029 St. Johns National Academy of Health Date of approval March 8, 2010* Date of approval December 22, 2008 Sciences, Total budget Rs 13, 09, 091 Koramangala, Sarjapur Road, Total budget Rs 79, 20,000 Bangalore-560034 Duration 65 Months Duration 60 Months Subject area Oncology Subject area Cardiovascular Diseases

* Approved for AIIMS, New Delhi only * Approved for AIIMS, New Delhi only, later study dropped by funding agency

Indian Council of Medical Research 115 Indian Council of Medical Research 116

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects SAVE (Sleep Apnea cardio Vascular Endpoints) study : An international, multi-centre, open, 262 parallel group, prospective, randomized, controlled trial to determine the effectiveness of treatment with Continuous Positive Airways Pressure (CPAP) in addition to standard care in reducing Cardio-Vascular (CV) morbidity and mortality in patients with co-existing CV diseases and moderate-severe obstructive sleep apnea (OSA) Principal Investigator Funded by Dr. Hemalata Boyini National Health and Medical Research Council Project Manager, (NHMRC), Australia George Institute for International Health-India Office, * 839 C Road No. 44A, Date of approval March 8, 2010 Jubilee Hills, Total budget Rs 28, 79, 626 Hyderabad-500033 Duration 60 Months Subject area Cardiovascular Diseases

The main phase of an academic lead and conducted, international, multi-centre, open label, 263 blinded endpoint, randomised controlled trial to established the balance of benefits and risks of a treatment strategy of early intensive lowering of Blood Pressure (BP) compared to a conservative BP lowering policy in patients with the acute primary Inter-Cerebral Haemorrhage (ICH) and co- existing elevated BP without any definite indication or contraindication to treatment Principal Investigator Funded by Dr. Hemalata Boyini National Health and Medical Research Council Project Manager, (NHMRC), Australia George Institute for International Health-India Office, 839 C Road Date of approval March 8, 2010 ** No. 44A, Jubilee Hills, Hyderabad-500033 Total budget Rs 22, 94,166 Duration 30 Months Subject area Neurosciences

264 Kerala Diabetes Prevention Programme (K-DPP): A cluster randomized controlled trial of its effectiveness and cost-effectiveness

Principal Investigator Funded by Dr. K R Thankappan National Health and Medical Research Council (NHMRC), Australia Professor & Head, Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), (Trivandrum), Date of approval December 10, 2012* ** Thiruvananthapuram-695011 Total budget Rs 1, 83, 25, 686 Duration 60 Months Subject area Diabetes

* Modified proposal approved for nine active sites in HMSC meeting held on September 10, 2012 ** Approved for 7 sites only with conditions *** Approved with conditions

117

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects SAVE (Sleep Apnea cardio Vascular Endpoints) study : An international, multi-centre, open, 262 265 Genotypic characterization of Japanese Encephalitis Virus (JEV) in different endemic areas of parallel group, prospective, randomized, controlled trial to determine the effectiveness of India and Vietnam: its implications on the vector- pathogen interactions treatment with Continuous Positive Airways Pressure (CPAP) in addition to standard care in reducing Cardio-Vascular (CV) morbidity and mortality in patients with co-existing CV diseases and moderate-severe obstructive sleep apnea (OSA) Principal Investigator Funded by Principal Investigator Funded by Dr. B K Tyagi National Institute of Hygiene and Epidemiology, National Health and Medical Research Council Hanoi, Vietnam (through DST, New Delhi) Dr. Hemalata Boyini Scientist F & Officer in Charge, Project Manager, (NHMRC), Australia Centre for Research in Medical George Institute for International Entomology (CRME), Health-India Office, 4 Sarojani Street, Chinna Chokkikulam, Date of approval March 8, 2010 * Date of approval December 22, 2008* 839 C Road No. 44A, Madurai-625002 Jubilee Hills, Total budget Rs 28, 79, 626 Total budget Rs 5, 08, 00, 000 Hyderabad-500033 Duration 60 Months Duration 36 Months Subject area Cardiovascular Diseases Subject area Japanese Encephalitis

The main phase of an academic lead and conducted, international, multi-centre, open label, 263 266 Laboratory - based collaboration network of infectious diseases in Asia blinded endpoint, randomised controlled trial to established the balance of benefits and risks of a treatment strategy of early intensive lowering of Blood Pressure (BP) compared to a conservative BP lowering policy in patients with the acute primary Inter-Cerebral Haemorrhage (ICH) and co- existing elevated BP without any definite indication or contraindication to treatment Principal Investigator Funded by Principal Investigator Funded by Dr. Sekhar Chakraborti National Institute of Infectious Diseases, Japan Dr. Hemalata Boyini National Health and Medical Research Council Scientist G, Project Manager, (NHMRC), Australia National Institute of Cholera and George Institute for International Enteric Diseases (NICED), P-33, CIT Road, Scheme XM, Health-India Office, 839 C Road Date of approval March 8, 2010 ** Date of approval September 8, 2011 No. 44A, Jubilee Hills, Beliaghata, Total budget Rs 42, 00, 000 Hyderabad-500033 Total budget Rs 22, 94,166 Kolkata-700010 Duration 30 Months Duration 36 Months Subject area Neurosciences Subject area Other Infectious Diseases

264 Kerala Diabetes Prevention Programme (K-DPP): A cluster randomized controlled trial of its 267 A Thermostable Measles Vaccine effectiveness and cost-effectiveness

Principal Investigator Funded by Principal Investigator Funded by Dr. K R Thankappan National Health and Medical Research Council Dr. Rajeev Dhere National Institutes of Health, USA (NHMRC), Australia Professor & Head, Director, Sree Chitra Tirunal Institute for Serum Institute of India Ltd., Medical Sciences & Technology 212/2, Hadapsar, (SCTIMST), (Trivandrum), Pune-411028 Date of approval December 10, 2012* ** Date of approval March 25, 2008 Thiruvananthapuram-695011 Total budget Rs 1, 83, 25, 686 Total budget Rs 1, 38, 25, 320 Duration 60 Months Duration 36 Months Subject area Diabetes Subject area Child Health

* Modified proposal approved for nine active sites in HMSC meeting held on September 10, 2012 * Funded by DST for exchange visits only (Rs.15 Lakh appox) with no additional funds required by Indian PI ** Approved for 7 sites only with conditions *** Approved with conditions

Indian Council of Medical Research 117 Indian Council of Medical Research 118

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

268 NeuroAIDS in India

Principal Investigator Funded by Dr. Sanjay Mehendale National Institutes of Health, USA Scientist F, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval March 25, 2008 Pune-411026 Total budget Rs 4, 74, 57, 855 Duration 60 Months Subject area HIV/AIDS/ STD

269 Type 1 Diabetes Genetics Consortium (TIDGC) - An international effort

Principal Investigator Funded by Dr. Alok Kanungo National Institutes of Health, USA Chairman, Cuttack Diabetes Research Foundation, Chandi Road, Cuttack-753001 Date of approval March 25, 2008 Total budget Rs 11, 25, 000 Duration 24 Months Subject area Diabetes

270 Capacity building for tobacco cessation in India and Indonesia

Principal Investigator Funded by Dr. K R Thankappan National Institutes of Health, USA Professor & Head, Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram-695011 Date of approval March 25, 2008 Total budget Rs 2, 58, 84, 000 Duration 60 Months Subject area Life Style Diseases

119

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

268 NeuroAIDS in India 271 ASHA HIV Health Promotion Intervention in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Sanjay Mehendale National Institutes of Health, USA Dr. K K Ganguly National Institutes of Health, USA Scientist F, Scientist E, National AIDS Research Institute (NARI), Indian Council Medical Research (ICMR), 73 G Block, MIDC, Bhosari, Ansari Nagar, Post Box No. 1875, New Delhi-110029 Date of approval March 25, 2008 Date of approval June 23, 2008 * Pune-411026 Total budget Rs 4, 74, 57, 855 Total budget Rs 40, 00, 000 Duration 60 Months Duration 36 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

269 Type 1 Diabetes Genetics Consortium (TIDGC) - An international effort 272 STRIDE: A strategy study of immediate versus deferred initiation of antiretroviral therapy for AIDS Diseases-Free survival in HIV-infected persons treated for tuberculosis with CD4< 250 Cells / cubic mm Principal Investigator Funded by Principal Investigator Funded by Dr. Alok Kanungo National Institutes of Health, USA Dr. Srikanth P Tripathy National Institutes of Health, USA Chairman, Scientist F, Cuttack Diabetes Research Foundation, National AIDS Research Institute Chandi Road, (NARI), 73 G Block, MIDC, Bhosari, Cuttack-753001 Post Box No. 1875, Date of approval March 25, 2008 Date of approval June 23, 2008 ** Pune-411026 Total budget Rs 11, 25, 000 Total budget Rs 1, 10, 00, 000 Duration 24 Months Duration 12 Months Subject area Diabetes Subject area HIV/AIDS/ STD

270 Capacity building for tobacco cessation in India and Indonesia 273 Caliciviral infections and disease in Southern India

Principal Investigator Funded by Principal Investigator Funded by Dr. K R Thankappan National Institutes of Health, USA Dr. Gagandeep Kang National Institutes of Health, USA Professor & Head, Professor, Sree Chitra Tirunal Institute for Medical Christian Medical College & Hospital, Sciences & Technology (SCTIMST), Ida Scudder Road, Thiruvananthapuram-695011 Vellore-632004 Date of approval March 25, 2008 Date of approval June 23, 2008 Total budget Rs 2, 58, 84, 000 Total budget Rs 33, 20, 000 Duration 60 Months Duration 36 Months Subject area Life Style Diseases Subject area Diarrhoeal Diseases

* Approved with conditions ** Formal approval granted by Chairman, HMSC in October, 2008 and revised protocol with modified tiile endorsed in HMSC meeting held on June 8, 2009

Indian Council of Medical Research 119 Indian Council of Medical Research 120

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

274 Immune response to cryptosporidiosis in a birth cohort of children of South India

Principal Investigator Funded by Dr. Gagandeep Kang National Institutes of Health, USA Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval June 23, 2008 Total budget Rs 5, 65, 73, 760 Duration 60 Months Subject area Diarrhoeal Diseases

275 Indo-US collaborative platform for vaccine development against Chlamydia

Principal Investigator Funded by Dr. Aruna Singh nee Mittal National Institutes of Health, USA Scientist F, Institute of Pathology, Safdarjung Hospital Campus, Post Box 4909, Date of approval June 23, 2008 * New Delhi-110029 Total budget Rs 9, 12, 200 Duration 36 Months Subject area Reproductive Health

276 A single arm, open label pilot study of the safety and immunogenicity of the Merck quadrivalent Human Papilloma Virus (HPV) vaccine among HIV - positive women in India: A trial of the AIDS Malignancy: Clinical trials consortium (AMC)

Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Chief Medical Officer, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 22, 2008 Chennai-600113 Total budget Rs 61, 74, 770 Duration 48 Months Subject area Oncology

* Approved with conditions

121

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

274 Immune response to cryptosporidiosis in a birth cohort of children of South India 277 A5207 Maintaining Options for Mothers Study (MOMS) - A phase II randomized comparison of three antiretroviral strategies administered for 7 or 21 days to reduce the emergence of nevirapine resistant HIV-1 following a single intrapartum dose of nevirapine

Principal Investigator Funded by Principal Investigator Funded by Dr. Gagandeep Kang National Institutes of Health, USA Dr. A V Jamkar National Institutes of Health, USA Professor, Dean, Christian Medical College & Hospital, B J Medical College and Sassoon Ida Scudder Road, General Hospital, Vellore-632004 Jai Prakash Narayan Road, Date of approval June 23, 2008 Date of approval December 22, 2008 Pune-411001 Total budget Rs 5, 65, 73, 760 Total budget Rs 3, 71, 76, 364 Duration 60 Months Duration 24 Months Subject area Diarrhoeal Diseases Subject area HIV/AIDS/ STD

275 Indo-US collaborative platform for vaccine development against Chlamydia 278 Development and validation of fundal height measure tape to estimate gestational age-A hospital based descriptive observational study

Principal Investigator Funded by Principal Investigator Funded by Dr. Aruna Singh nee Mittal National Institutes of Health, USA Dr. Bhalachandra S Kodkany National Institutes of Health, USA Scientist F, Professor, Institute of Pathology, Jawaharlal Nehru Medical College, Safdarjung Hospital Campus, JNMC Campus, Nehru Nagar, Post Box 4909, Belgaum-590010 Date of approval June 23, 2008 * Date of approval December 22, 2008 New Delhi-110029 Total budget Rs 9, 12, 200 Total budget Rs 1, 31, 560 Duration 36 Months Duration 8 Months Subject area Reproductive Health Subject area Reproductive Health

276 A single arm, open label pilot study of the safety and immunogenicity of the Merck quadrivalent 279 Maternal and newborn health registry & evaluation of an Emergency Obstetric and Newborn Care Human Papilloma Virus (HPV) vaccine among HIV - positive women in India: A trial of the (EmONC) intervention package to reduce adverse pregnancy outcomes in low resource settings - AIDS Malignancy: Clinical trials consortium (AMC) The EmONC Trial

Principal Investigator Funded by Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Dr. Bhalachandra S Kodkany National Institutes of Health, USA Chief Medical Officer, Professor, Y R Gaitonde Centre for AIDS Jawaharlal Nehru Medical College, Research and Education (YRG CARE), JNMC Campus, Nehru Nagar, Voluntary Health Services, Taramani, Belgaum-590010 Date of approval December 22, 2008 Date of approval December 22, 2008 Chennai-600113 Total budget Rs 61, 74, 770 Total budget Rs 5, 12, 94, 260 Duration 48 Months Duration 60 Months Subject area Oncology Subject area Reproductive Health

* Approved with conditions

Indian Council of Medical Research 121

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

280 Maternal and newborn health registry & evaluation of an Emergency Obstetric and Newborn Care (EmONC) Intervention Package to reduce adverse pregnancy outcomes in low resources settings- The EmONC Trial

Principal Investigator Funded by Dr. Archana Patel National Institutes of Health, USA Professor & Head, Lata Medical Research Foundation, Kinkine Kutir, Vasant Nagar Colony Near Deeksha Bhoomi Square, Date of approval December 22, 2008 * Nagpur-440022 Total budget Rs 4, 70, 27, 660 Duration 60 Months Subject area Reproductive Health P1060: National Institutes of Health, USA -sponsored Phase II, parallel, randomized clinical trials 281 comparing the responses to initiation of NNRTI-based versus Protease Inhibitor (PI) -Based antiretroviral therapy in HIV infected infants who have and have not previously received single dose nevirapine for prevention of mother to child HIV transmission under the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) network to be conducted Principal Investigator Funded by Dr. A V Jamkar National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval December 22, 2008 ** Pune-411001 Total budget Rs 1, 30, 22, 005 Duration 36 Months Subject area HIV/AIDS/ STD

282 Rapid low cost molecular detection of influenza virus infections

Principal Investigator Funded by Dr. Shobha Broor National Institutes of Health, USA Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 22, 2008 Total budget Rs 19, 87, 560 Duration 24 Months Subject area Influenza

* Approved with conditions ** Clarifications found satisfactory, approved and endorsed in HMSC meeting held on June 8, 2011

Indian Council of Medical Research 123

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

280 Maternal and newborn health registry & evaluation of an Emergency Obstetric and Newborn Care 283 Sjogren's International Collaborative Clinical Alliance (SICCA) (EmONC) Intervention Package to reduce adverse pregnancy outcomes in low resources settings- The EmONC Trial

Principal Investigator Funded by Principal Investigator Funded by Dr. Archana Patel National Institutes of Health, USA Dr. M Srinivasan National Institutes of Health, USA Professor & Head, Director, Lata Medical Research Foundation, Aravind Eye Hospital & PG Institute of Kinkine Kutir, Vasant Nagar Colony Ophthalmology, Near Deeksha Bhoomi Square, 1, Annanagar, Date of approval December 22, 2008 * Date of approval December 22, 2008 Nagpur-440022 Madurai-625020 Total budget Rs 4, 70, 27, 660 Total budget Rs 44, 18, 108 Duration 60 Months Duration 36 Months Subject area Reproductive Health Subject area Ophthalmology P1060: National Institutes of Health, USA -sponsored Phase II, parallel, randomized clinical trials comparing the responses to initiation of NNRTI-based versus Protease Inhibitor (PI) -Based 281 284 Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) antiretroviral therapy in HIV infected infants who have and have not previously received single dose nevirapine for prevention of mother to child HIV transmission under the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) network to be conducted Principal Investigator Funded by Principal Investigator Funded by Dr. D Prabhakaran National Institutes of Health, USA Dr. A V Jamkar National Institutes of Health, USA Dean, Executive Director, B J Medical College and Sassoon Center for Chronic Disease Control General Hospital, (CCDC), C1/52, Second Floor, Jai Prakash Narayan Road, ** Safdarjung Development Area, Date of approval December 22, 2008 Date of approval December 22, 2008 * Pune-411001 New Delhi-110016 Total budget Rs 1, 30, 22, 005 Total budget Rs 4, 29, 40,450 Duration 36 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Cardiovascular Diseases

282 Rapid low cost molecular detection of influenza virus infections 285 A strategy study of immediate versus deferred initiation of antiretroviral therapy for HIV-infected persons treated for tuberculosis with CD4<200 cells/ cubic mm

Principal Investigator Funded by Principal Investigator Funded by Dr. Shobha Broor National Institutes of Health, USA Dr. N Kumarasamy National Institutes of Health, USA Professor, Chief Medical Officer, All India Institute of Medical Sciences Y R Gaitonde Centre for AIDS (AIIMS), Ansari Nagar, Research and Education (YRG CARE), New Delhi-110029 Voluntary Health Services, Taramani, Date of approval December 22, 2008 Date of approval March 2, 2009 Chennai-600113 Total budget Rs 19, 87, 560 Total budget Rs 1, 00, 30,765 Duration 24 Months Duration 48 Months Subject area Influenza Subject area HIV/ Tuberculosis

* Approved with conditions * Approved with conditions ** Clarifications found satisfactory, approved and endorsed in HMSC meeting held on June 8, 2011

Indian Council of Medical Research 123

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

286 Dissecting the role of HIV-1 Tat and the chemokine axis in subtype - specificity

Principal Investigator Funded by Dr. Ranga Udaykumar National Institutes of Health, USA Associate Professor, Jawaharlal Nehru Centre for Advance Science Research (JNCASR), Jakkur (PO), Date of approval March 2, 2009 Bangalore-560064 Total budget Rs 20, 00, 000 Duration 60 Months Subject area HIV/AIDS/ STD

287 Impact of intestinal dysfunction on antiretroviral therapy in India

Principal Investigator Funded by Dr. Rita Isaac National Institutes of Health, USA Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval March 2, 2009 Total budget Rs 1, 10, 70, 164 Duration 60 Months Subject area HIV/AIDS/ STD

288 Enhancing HIV medication adherence in India

Principal Investigator Funded by Dr. Ajay Wanchu National Institutes of Health, USA Additional Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval March 2, 2009 Chandigarh-160012 Total budget Rs 1, 39, 692 Duration 12 Months Subject area HIV/AIDS/ STD

125

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

286 Dissecting the role of HIV-1 Tat and the chemokine axis in subtype - specificity 289 Novel DNA vaccines for Chikungunya virus

Principal Investigator Funded by Principal Investigator Funded by Dr. Ranga Udaykumar National Institutes of Health, USA Dr. P Vijayachari National Institutes of Health, USA Associate Professor, Scientist G & Director, Jawaharlal Nehru Centre for Advance Regional Medical Research Centre Science Research (JNCASR), (RMRC), Jakkur (PO), Post Bag No. 13, Date of approval March 2, 2009 Date of approval March 2, 2009 Bangalore-560064 Port Blair-744101 Total budget Rs 20, 00, 000 Total budget Rs 24, 97,700 Duration 60 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Other Infectious Diseases

287 Impact of intestinal dysfunction on antiretroviral therapy in India 290 Role of cocaine in Neuro-AIDS by HIV-1 B and C Clades

Principal Investigator Funded by Principal Investigator Funded by Dr. Rita Isaac National Institutes of Health, USA Dr. Shailendra K Saxena National Institutes of Health, USA Professor, Senior Scientist, Christian Medical College & Hospital, Centre for Cellular and Molecular Ida Scudder Road, Biology (CCMB), CSIR, Vellore-632004 Uppal Road, Date of approval March 2, 2009 Date of approval March 2, 2009 Hyderabad-500007 Total budget Rs 1, 10, 70, 164 Total budget Rs 1, 02, 56, 200 Duration 60 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

288 Enhancing HIV medication adherence in India 291 Tobacco Evaluation Policy in Low and Middle Income Countries (In India the ITC project is known as the TCP India Project to avoid confusion with the India Tobacco Company)

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajay Wanchu National Institutes of Health, USA Dr. Prakash C Gupta National Institutes of Health, USA Additional Professor, Director, Post Graduate Institute of Medical Healis-Sekhasaria Institute for Public Education and Research (PGIMER), Health, 601/B, Great Eastern Sector 12-D, Chambers, Plot No. 28, Sector-11, Date of approval March 2, 2009 Date of approval March 2, 2009* Chandigarh-160012 CBD Belapur, Total budget Rs 1, 39, 692 Mumbai-400614 Total budget Rs 1, 97, 35, 960 Duration 12 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Life Style Diseases

* Approved with suggestion

Indian Council of Medical Research 125 Indian Council of Medical Research 126

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

292 Structure-based development of nonnucleoside anti-HIV-1 RT Drugs

Principal Investigator Funded by Dr. Anamik Shah National Institutes of Health, USA Professor, Saurashtra University, Saurashtra University Campus, Rajkot-360005 Date of approval March 2, 2009* Total budget Rs 5, 26, 686 Duration 24 Months Subject area HIV/AIDS/ STD

293 Diversity of HIV and HCV among IDUs in India - Administrative supplement to "Incidence of HIV in a cohort of IV drug users" (RO1 DA12568)

Principal Investigator Funded by Dr. Sunil Suhas Solomon National Institutes of Health, USA Senior Medical Officer, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval June 8, 2009 * Chennai-600113 Total budget Rs 36, 73, 120 Duration 12 Months Subject area HIV/AIDS/ STD

294 Fighting malaria with microfinance: Evidence from India

Principal Investigator Funded by Dr. Lakshmi Krishnan National Institutes of Health, USA Program Head, Centre for Micro Finance, 8th Floor, West Wing, Fountain Plaza Khaleel Shirazi Estate, Date of approval June 8, 2009** 31/2A, Pantheon Road Egmore, Chennai-600008 Total budget Rs 1, 15, 60, 260 Duration 24 Months Subject area Malaria

* Approved with conditions ** Approved wth suggestions

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

292 Structure-based development of nonnucleoside anti-HIV-1 RT Drugs 295 Global health activities in developing countries to combat non communicable chronic cardiovascular and pulmonary diseases - Centre of Excellence

Principal Investigator Funded by Principal Investigator Funded by Dr. Anamik Shah National Institutes of Health, USA Dr. Denis Xavier National Institutes of Health, USA Professor, Associate Professor, Saurashtra University, St. Johns Medical College, St. Johns Saurashtra University Campus, Research Institute, Rajkot-360005 St. Johns National Academy of Health Date of approval March 2, 2009* Date of approval June 8, 2009 Sciences, Total budget Rs 5, 26, 686 Koramangala, Sarjapur Road, Total budget Rs 9, 38, 03,530 Bangalore-560034 Duration 24 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Cardiovascular Diseases

293 Diversity of HIV and HCV among IDUs in India - Administrative supplement to "Incidence of 296 High risk men in India- an important bridge population HIV in a cohort of IV drug users" (RO1 DA12568)

Principal Investigator Funded by Principal Investigator Funded by Dr. Sunil Suhas Solomon National Institutes of Health, USA Dr. Hemangi Jerajani National Institutes of Health, USA Senior Medical Officer, Professor & Head, Y R Gaitonde Centre for AIDS LTMG Hospital & LTM Medical Research and Education (YRG CARE), College Sion, Voluntary Health Services, Taramani, Mumbai-400022 Date of approval June 8, 2009 * Date of approval June 8, 2009 Chennai-600113 Total budget Rs 36, 73, 120 Total budget Rs 18, 80, 000 Duration 12 Months Duration 12-18 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

294 Fighting malaria with microfinance: Evidence from India 297 Immune response to cryptosporidial antigens in HIV infected adults in South India

Principal Investigator Funded by Principal Investigator Funded by Dr. Lakshmi Krishnan National Institutes of Health, USA Dr. Sitara Rao National Institutes of Health, USA Program Head, Lecturer, Centre for Micro Finance, Christian Medical College & Hospital, 8th Floor, West Wing, Fountain Plaza Ida Scudder Road, Khaleel Shirazi Estate, Vellore- 632004 Date of approval June 8, 2009** Date of approval June 8, 2009 31/2A, Pantheon Road Egmore, Chennai-600008 Total budget Rs 1, 15, 60, 260 Total budget Rs 15, 98, 080 Duration 24 Months Duration 12 Months Subject area Malaria Subject area HIV/AIDS/ STD

* Approved with conditions ** Approved wth suggestions

Indian Council of Medical Research 127 128

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

298 Prevalence and correlates of HIV/STI among FSW in Nagpur, Maharashtra

Principal Investigator Funded by Mr. A K Srikrishnan National Institutes of Health, USA Research Manager, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval June 8, 2009 Chennai-600113 Total budget Rs 11, 11, 920 Duration 12 Months Subject area HIV/AIDS/ STD

299 Study of social networks and HIV related risk - taking behaviors of truck drivers and cleaners in Hyderabad, India

Principal Investigator Funded by Dr. Lalit Dandona National Institutes of Health, USA Professor, Public Health Foundation of India, 4/2, Sirifort Institutional Area, August Kranti Marg, Date of approval June 8, 2009 New Delhi-110016 Total budget Rs 2, 75, 000 Duration 12 Months Subject area HIV/AIDS/ STD

300 Structural interventions for HIV prevention in risky venues in India

Principal Investigator Funded by Dr. Suniti Solomon National Institutes of Health, USA Director, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval June 8, 2009 Chennai-600113 Total budget Rs 12, 36, 969 Duration 24 Months Subject area HIV/AIDS/ STD

129

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

298 Prevalence and correlates of HIV/STI among FSW in Nagpur, Maharashtra 301 To establish a Centre of Excellence (COE) for prevention and control of cardio - metabolic diseases in South Asia for population based applied research and training

Principal Investigator Funded by Principal Investigator Funded by Mr. A K Srikrishnan National Institutes of Health, USA Dr. D Prabhakaran National Institutes of Health, USA Research Manager, Executive Director, Y R Gaitonde Centre for AIDS Center for Chronic Disease Control Research and Education (YRG CARE), (CCDC), C1/52, Second Floor, Voluntary Health Services, Taramani, Safdarjung Development Area, Date of approval June 8, 2009 Date of approval June 8, 2009 Chennai-600113 New Delhi-110016 Total budget Rs 11, 11, 920 Total budget Rs 97, 76, 606 Duration 12 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Cardiovascular Diseases/ Diabetes 299 Study of social networks and HIV related risk - taking behaviors of truck drivers and cleaners in 302 Interdisciplinary Research Training: Non Communicable Disease (NCD) epidemiology and Hyderabad, India prevention in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Lalit Dandona National Institutes of Health, USA Dr. Nikhil Tandon National Institutes of Health, USA Professor, Professor, Public Health Foundation of India, All India Institute of Medical Sciences 4/2, Sirifort Institutional Area, (AIIMS), Ansari Nagar, August Kranti Marg, New Delhi-110029 Date of approval June 8, 2009 Date of approval September 8, 2009 * New Delhi-110016 Total budget Rs 2, 75, 000 Total budget Rs 5, 68, 13, 836 Duration 12 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Epidemiology of NCDs

300 Structural interventions for HIV prevention in risky venues in India 303 International Research and Research Training - Long term training programme

Principal Investigator Funded by Principal Investigator Funded by Dr. Suniti Solomon National Institutes of Health, USA Dr. Sanjay Mehendale National Institutes of Health, USA Director, Scientist G & Director, Y R Gaitonde Centre for AIDS National Institute of Epidemiology, R- Research and Education (YRG CARE), 127, 3rd Avenue, Tamil Nadu Housing Voluntary Health Services, Taramani, Board, Ayapakkam, Date of approval June 8, 2009 Date of approval September 8, 2009 ** Chennai-600113 Chennai-600077 Total budget Rs 12, 36, 969 Total budget Rs 6, 81, 62,500 Duration 24 Months Duration 48 Months Subject area HIV/AIDS/ STD Subject area Bioethics

* Approved with a suggestion ** * Approved with conditions and change of PI from Dr. Kumaraswami to Dr. Sanjay Mehendale, NIE, Chennai approved in HMSC meeting held on December 8, 2011

Indian Council of Medical Research 129 130

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

304 Validation of the role of multi spectral imaging system & focal reflectance spectroscopy and laser induced fluorescent spectroscopy in early diagnosis of oral cancers

Principal Investigator Funded by Dr. Pankaj Chaturvedi National Institutes of Health, USA Associate Professor, Tata Memorial Hospital, Tata Memorial Centre, Parel, Mumbai-400012 Date of approval September 8, 2009 Total budget Rs 41, 02, 600 Duration 24 Months Subject area Oncology

305 Adolescent women and microbicide trials: Assessing the challenges and oppurtunities in their participation

Principal Investigator Funded by Dr. Jayagowri Sastry National Institutes of Health, USA Principal Investigator, Maharashtra Association of Anthropological Sciences (MASS), 64/5, Anand Park, Date of approval December 8, 2009* Pune-411007 Total budget Rs 1, 34, 66, 260 Duration 36 Months Subject area HIV/AIDS/ STD

306 Assessment of HIV incidence and its determinants in a population-based longitudinal cohort study in India

Principal Investigator Funded by Dr. Lalit Dandona National Institutes of Health, USA Professor, Public Health Foundation of India, 4/2, Sirifort Institutional Area, August Kranti Marg, Date of approval December 8, 2009* New Delhi-110016 Total budget Rs 3, 28, 50, 000 Duration 48 Months Subject area HIV/AIDS/ STD

* Approved with conditions

131

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

304 Validation of the role of multi spectral imaging system & focal reflectance spectroscopy and laser 307 Dose - finding and pharmacogenetic study of Efavirenz in HIV-Infected and HIV-TB co-infected induced fluorescent spectroscopy in early diagnosis of oral cancers infants and children> 3 months to <36 months of age

Principal Investigator Funded by Principal Investigator Funded by Dr. Pankaj Chaturvedi National Institutes of Health, USA Dr. Arun Jamkar National Institutes of Health, USA Associate Professor, Dean, Tata Memorial Hospital, B J Medical College and Sassoon Tata Memorial Centre, Parel, General Hospital, Mumbai-400012 Jai Prakash Narayan Road, Date of approval September 8, 2009 Date of approval December 8, 2009* Pune-411001 Total budget Rs 41, 02, 600 Total budget Rs 46, 82, 074 Duration 24 Months Duration 9 Months Subject area Oncology Subject area HIV/ Tuberculosis

305 Adolescent women and microbicide trials: Assessing the challenges and oppurtunities in their 308 Feasibility study of HIV database and cancer registry matching participation

Principal Investigator Funded by Principal Investigator Funded by Dr. Jayagowri Sastry National Institutes of Health, USA Dr. Sheela Godbole National Institutes of Health, USA Principal Investigator, Scientist D, Maharashtra Association of National AIDS Research Institute Anthropological Sciences (MASS), (NARI), 73 G Block, MIDC, Bhosari, 64/5, Anand Park, Post Box No. 1875, Date of approval December 8, 2009* Date of approval December 8, 2009 Pune-411007 Pune-411026 Total budget Rs 1, 34, 66, 260 Total budget Rs 12, 85, 920 Duration 36 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

306 Assessment of HIV incidence and its determinants in a population-based longitudinal cohort study 309 Genetic analysis of psoriasis and psoriatic arthritis in Indians in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Lalit Dandona National Institutes of Health, USA Dr. Vinod Sharma National Institutes of Health, USA Professor, Professor & Head, Public Health Foundation of India, All India Institute of Medical Sciences 4/2, Sirifort Institutional Area, (AIIMS), Ansari Nagar, August Kranti Marg, New Delhi-110029 Date of approval December 8, 2009* Date of approval December 8, 2009* New Delhi-110016 Total budget Rs 3, 28, 50, 000 Total budget Rs 68, 85, 000 Duration 48 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Genomics

* Approved with conditions * Approved with conditions

Indian Council of Medical Research 131 Indian Council of Medical Research 132

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

310 Mycotic ulcer treatment trial (MUTT)

Principal Investigator Funded by Dr. Venkatesh Pranja National Institutes of Health, USA Chief Medical Officer, Aravind Eye Hospital & PG Institute of Ophthalmology, 1, Annanagar, Date of approval December 8, 2009 Madurai-625020 Total budget Rs 86, 50, 000 Duration 48 Months Subject area Ophthalmology

311 Pilot intervention to prevent HIV/STIs among female sex workers in central India

Principal Investigator Funded by Dr. Suniti Solomon National Institutes of Health, USA Director, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 8, 2009* Chennai-600113 Total budget Rs 84, 31, 061 Duration 24 Months Subject area HIV/AIDS/ STD

312 Sensitivity and specificity of Mycobacterium tuberculosis screening and diagnostics in HIV- infected individuals

Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval December 8, 2009* Pune-411001 Total budget Rs 30, 67, 921 Duration 15 Days Subject area HIV/ Tuberculosis

* Approved with conditions

133

Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects

313 Smokeless tobacco use and reproductive health among married women in a low - income community

Principal Investigator Funded by Dr. Sarita Nair National Institutes of Health, USA Scientist C, National Institute of Research in Reproductive Health (NIRRH), Jehangir Merwanji Street, Parel, Date of approval December 8, 2009 Mumbai-400012 Total budget Rs 56, 85, 073 Duration 36 Months Subject area Reproductive Health

314 A study of patients in resource-limited areas with cancer who also have HIV: A trail of the AIDS malignancy clinical trials consortium

Principal Investigator Funded by Dr. Sanjeev Sinha National Institutes of Health, USA Associate Professor, ,All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2010 Total budget Rs 4, 70,000 Duration 6 Months Subject area HIV/AIDS/ STD

315 A study of patients in resource limited areas with cancer who also have HIV: A trial of the AIDS malignancy clinical trials consortium

Principal Investigator Funded by Dr. Aruna Alahari Dhir National Institutes of Health, USA Professor & Head, Tata Memorial Hospital, Tata Memorial Centre, Parel, Mumbai-400012 Date of approval March 8, 2010 Total budget Rs 3, 76, 000 Duration 6 Months Subject area HIV/AIDS/ STD

134

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

316 An exploratory study of risk stratification, cognitive evaluation, genetic correlates and locus of control in relatives of Schizophrenia subjects

Principal Investigator Funded by Dr. Triptish Bhatia National Institutes of Health, USA Post Doctoral Scholar, Dr. Ram Manohar Lohia Hospital, Baba Kharag Singh Marg, New Delhi-110001 Date of approval March 8, 2010 Total budget Rs 11, 72, 925 Duration 24 Months Subject area Mental Health

317 Circadian rhythm and cognitive impairment among the participants affected with Schizophrenia and bipolar disorder

Principal Investigator Funded by Dr. Promod Thomas National Institutes of Health, USA Post Doctoral Scholar, Dr. Ram Manohar Lohia Hospital, Baba Kharag Singh Marg, New Delhi-110001 Date of approval March 8, 2010 Total budget Rs 9, 34, 875 Duration 23 Months Subject area Mental Health

318 Implementing PATH India to reduce HIV risk among substance users in India: Assessing HIV risk among community clinic clients

Principal Investigator Funded by Dr. Bankteshwar Mani Tripathi National Institutes of Health, USA Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2010* Total budget Rs 12, 92, 510 Duration 12 Months Subject area HIV/ Tuberculosis

* Approved with a condition

135

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

316 An exploratory study of risk stratification, cognitive evaluation, genetic correlates and locus of 319 Longitudinal Ageing Study in India (LASI) control in relatives of Schizophrenia subjects

Principal Investigator Funded by Principal Investigator Funded by Dr. Triptish Bhatia National Institutes of Health, USA Dr. P Arokiasamy National Institutes of Health, USA Post Doctoral Scholar, Professor, Dr. Ram Manohar Lohia Hospital, International Institute for Population Baba Kharag Singh Marg, Sciences (IIPS), New Delhi-110001 Govandi Station Road, Deonar, Date of approval March 8, 2010 Date of approval March 8, 2010 * Mumbai-400088 Total budget Rs 11, 72, 925 Total budget Rs 58, 05, 000 Duration 24 Months Duration 24 Months Subject area Mental Health Subject area Life Style Diseases

317 Circadian rhythm and cognitive impairment among the participants affected with Schizophrenia 320 Measuring tobacco related mortality within the million death study in India and bipolar disorder

Principal Investigator Funded by Principal Investigator Funded by Dr. Promod Thomas National Institutes of Health, USA Dr. Prem Mony National Institutes of Health, USA Post Doctoral Scholar, Principal Investigator, Dr. Ram Manohar Lohia Hospital, St. Johns Medical College, St. Johns Baba Kharag Singh Marg, Research Institute, New Delhi-110001 St. Johns National Academy of Health Date of approval March 8, 2010 Date of approval March 8, 2010 * Sciences, Total budget Rs 9, 34, 875 Koramangala, Sarjapur Road, Total budget Rs 1, 16, 483 Bangalore-560034 Duration 23 Months Duration 120 Months Subject area Mental Health Subject area Life Style Diseases

318 Implementing PATH India to reduce HIV risk among substance users in India: Assessing HIV 321 Privacy and confidentiality: Beliefs, expectations and protections in an Indian context risk among community clinic clients

Principal Investigator Funded by Principal Investigator Funded by Dr. Bankteshwar Mani Tripathi National Institutes of Health, USA Dr. N N Mishra National Institutes of Health, USA Professor, Post Doctoral Scholar, All India Institute of Medical Sciences Dr. Ram Manohar Lohia Hospital, (AIIMS), Ansari Nagar, Baba Kharag Singh Marg, New Delhi-110029 New Delhi-110001 Date of approval March 8, 2010* Date of approval March 8, 2010 Total budget Rs 12, 92, 510 Total budget Rs 11, 49, 075 Duration 12 Months Duration 23 Months Subject area HIV/ Tuberculosis Subject area Mental Health

* Approved with a condition * Approved with conditions

Indian Council of Medical Research 135 Indian Council of Medical Research 136

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

322 Rapid tests for drug resistance to detect extensively drug resistant tuberculosis

Principal Investigator Funded by Dr. Camilla Rodrigues National Institutes of Health, USA Consultant Microbiologist, P D Hinduja National Hospital, Veer Savarkar Marg, Mahim West, Mumbai-400016 Date of approval March 8, 2010 Total budget Rs 2, 47, 82,256 Duration 60 Months Subject area Tuberculosis

323 Regulation of rRNA genes in Entamoeba histolytica: Biochemical and EM analysis

Principal Investigator Funded by Dr. Sudha Bhattacharya National Institutes of Health, USA Professor, Jawaharlal Nehru University, New Mehrauli Road, New Delhi-110067 Date of approval March 8, 2010 Total budget Rs 72, 00, 000 Duration 36 Months Subject area Genomics

324 Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for international sites initiating Highly Active Antiretroviral Therapy (HAART) in infants and children < 5 years of age

Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval March 8, 2010 Pune-411001 Total budget Rs 54, 10, 497 Duration 48 Weeks Subject area HIV/AIDS/ STD

137

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

322 Rapid tests for drug resistance to detect extensively drug resistant tuberculosis 325 SPREAD Secondary Prevention of coRonary Events After Discharge from hospital: A randomized, open trial comparing post discharge interventions to standard care in Acute Coronary Syndrome (ACS) patients

Principal Investigator Funded by Principal Investigator Funded by Dr. Camilla Rodrigues National Institutes of Health, USA Dr. Rajeev Gupta National Institutes of Health, USA Consultant Microbiologist, Head, P D Hinduja National Hospital, Fortis Escorts Hospital, Veer Savarkar Marg, Mahim West, JLN Marg, Malviya Nagar, Mumbai-400016 Jaipur-302107 Date of approval March 8, 2010 Date of approval March 8, 2010 Total budget Rs 2, 47, 82,256 Total budget Rs 1, 80, 04, 032 Duration 60 Months Duration 30 Months Subject area Tuberculosis Subject area Cardiovascular Diseases

323 Regulation of rRNA genes in Entamoeba histolytica: Biochemical and EM analysis 326 The impact of yoga supplementation on cognitive function among Indian outpatients with Schizophrenia

Principal Investigator Funded by Principal Investigator Funded by Dr. Sudha Bhattacharya National Institutes of Health, USA Dr. Triptish Bhatia National Institutes of Health, USA Professor, Post Doctoral Scholar, Jawaharlal Nehru University, ,Dr. Ram Manohar Lohia Hospital, New Mehrauli Road, Baba Kharag Singh Marg, New Delhi-110067 New Delhi-110001 Date of approval March 8, 2010 Date of approval March 8, 2010 Total budget Rs 72, 00, 000 Total budget Rs 1, 20, 88,575 Duration 36 Months Duration 60 Months Subject area Genomics Subject area Mental Health

324 Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for international sites initiating 327 The impact of familiarity on a family intervention program for Schizophrenia Highly Active Antiretroviral Therapy (HAART) in infants and children < 5 years of age

Principal Investigator Funded by Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Dr. Satabdi Chakraborty National Institutes of Health, USA Dean, Post Doctoral Scholar, B J Medical College and Sassoon Dr. Ram Manohar Lohia Hospital, General Hospital, Baba Kharag Singh Marg, Jai Prakash Narayan Road, New Delhi-110001 Date of approval March 8, 2010 March 8, 2010 Pune-411001 Date of approval Total budget Rs 54, 10, 497 Total budget Rs 10, 32, 075 Duration 48 Weeks Duration 23 Months Subject area HIV/AIDS/ STD Subject area Mental Health

Indian Council of Medical Research 137 138

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

328 Tri-national training programme for psychiatric genetics in India

Principal Investigator Funded by Dr. Smita N Deshpande National Institutes of Health, USA Head of Department, Dr. Ram Manohar Lohia Hospital, Baba Kharag Singh Marg, New Delhi-110001 Date of approval March 8, 2010 Total budget Rs 2, 47, 50, 000 Duration 24 Months Subject area Mental Health

329 A phase I/II dose finding study of high dose fluconazole treatment in AIDS-associated cryptococcal meningitis

Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval June 8, 2010 Pune-411001 Total budget Rs 1, 06, 22, 494 Duration 24 Months Subject area HIV/AIDS/ STD

330 CARRS (Center for Cardiometabolic Risk Reduction in South Asia) Surveillance study

Principal Investigator Funded by Dr. D Prabhakaran National Institutes of Health, USA Executive Director, Center for Chronic Disease Control (CCDC), C1/52, Second Floor, Safdarjung Development Area, Date of approval June 8, 2010 * New Delhi-110016 Total budget Rs 3, 78, 85, 397 Duration 48 Months Subject area Cardiovascular Diseases/ Diabetes * Approved for third study site in HMSC meeting held on December 8, 2010

139

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects Developing and testing integrated, multi-factorial CArdiovascular disease Risk Reduction 328 Tri-national training programme for psychiatric genetics in India 331 delivery Strategies in South Asia (CARSS Translation Trail): A multisite, individually randomized controlled translational trial of a comprehensive care delivery package to reduce CVD among 1,120 T2DM patients in South Asia Principal Investigator Funded by Principal Investigator Funded by Dr. Smita N Deshpande National Institutes of Health, USA Dr. D Prabhakaran National Institutes of Health, USA Head of Department, Executive Director, Dr. Ram Manohar Lohia Hospital, Center for Chronic Disease Control Baba Kharag Singh Marg, (CCDC), C1/52, Second Floor, New Delhi-110001 Safdarjung Development Area, Date of approval March 8, 2010 Date of approval June 8, 2010 * New Delhi-110016 Total budget Rs 2, 47, 50, 000 Total budget Rs 4, 17, 38, 120 Duration 24 Months Duration 60 Months Subject area Mental Health Subject area Cardiovascular Diseases

329 A phase I/II dose finding study of high dose fluconazole treatment in AIDS-associated 332 Identifying variants causal for Type 2 diabetes in major human populations cryptococcal meningitis

Principal Investigator Funded by Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Prof. Shah Ebrahim National Institutes of Health, USA Dean, Professor, B J Medical College and Sassoon Center for Chronic Disease Control General Hospital, (CCDC), C1/52, Second Floor, Jai Prakash Narayan Road, Safdarjung Development Area, Date of approval June 8, 2010 Date of approval June 8, 2010 Pune-411001 New Delhi-110016 Total budget Rs 1, 06, 22, 494 Total budget Rs 12, 95, 48, 610 Duration 24 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Diabetes

330 CARRS (Center for Cardiometabolic Risk Reduction in South Asia) Surveillance study 333 Mumbai worksite tobacco control study

Principal Investigator Funded by Principal Investigator Funded by Dr. D Prabhakaran National Institutes of Health, USA Dr. Prakash C Gupta National Institutes of Health, USA Executive Director, Director, Center for Chronic Disease Control Healis-Sekhasaria Institute for Public (CCDC), C1/52, Second Floor, Health, 601/B, Great Eastern Safdarjung Development Area, Chambers, Date of approval June 8, 2010 * Date of approval June 8, 2010 New Delhi-110016 Plot No. 28, Sector 11, Total budget Rs 3, 78, 85, 397 CBD Belapur, Total budget Rs 6, 00, 32, 920 Mumbai-400614 Duration 48 Months Duration 60 Months Subject area Cardiovascular Diseases/ Subject area Life Style Diseases Diabetes * Approved for third study site in HMSC meeting held on December 8, 2010 * Approved for remaining 8 study sites in HMSC meeting held on December 8, 2010 and inclusion of one more study site was endorsed on December 8, 2011

Indian Council of Medical Research 139 140

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

334 Sensitivity and specificity of Mycobacterium tuberculosis screening and diagnostics in HIV infected individuals

Principal Investigator Funded by Dr. Srikanth P Tripathy National Institutes of Health, USA Scientist F, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval June 8, 2010 Pune-411026 Total budget Rs 13, 04, 000 Duration 18 Months Subject area HIV/ Tuberculosis

335 Asia Pacific HIV Observational Database (APHOD)/Treat Asia HIV Observational Database (TAHOD)

Principal Investigator Funded by Dr. Sanjay Pujari National Institutes of Health, USA Director & Chief Consultant, Institute of Infectious Diseases, Kumar Business Court, D Wing Mukundnagar, Pune-411037 Date of approval September 8, 2010 * Total budget Rs 4, 85, 078 Duration 60 Months Subject area HIV/AIDS/ STD

336 Building enteric infectious disease research capacity in India

Principal Investigator Funded by Dr. Gagandeep Kang National Institutes of Health, USA Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval September 8, 2010 Total budget Rs 4, 46, 48, 820 Duration 48 Months Subject area Diarrhoeal Diseases

* Final approval granted in HMSC meeting held on March 8, 2011 with conditions

141

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

334 Sensitivity and specificity of Mycobacterium tuberculosis screening and diagnostics in HIV 337 Dil Mil (Hearts Together) empowering daughters and mothers in law to mitigate gender based infected individuals violence and promote women's health in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Srikanth P Tripathy National Institutes of Health, USA Dr. Krishnamachari Srinivasan National Institutes of Health, USA Scientist F, Vice Dean, National AIDS Research Institute (NARI), St. Johns Medical College, St. Johns 73 G Block, MIDC, Bhosari, Research Institute, Post Box No. 1875, St. Johns National Academy of Health Date of approval June 8, 2010 Date of approval September 8, 2010 * Pune-411026 Sciences, Total budget Rs 13, 04, 000 Koramangala, Sarjapur Road, Total budget Rs 42, 11, 685 Bangalore-560034 Duration 18 Months Duration 24 Months Subject area HIV/ Tuberculosis Subject area Social & Behavioural Research 335 Asia Pacific HIV Observational Database (APHOD)/Treat Asia HIV Observational Database 338 Integrating depression screening in HIV care in Southern India (TAHOD)

Principal Investigator Funded by Principal Investigator Funded by Dr. Sanjay Pujari National Institutes of Health, USA Dr. Rani Mohanraj National Institutes of Health, USA Director & Chief Consultant, Psychologist, Institute of Infectious Diseases, Kumar Christian Medical College & Hospital, Business Court, D Wing Mukundnagar, Ida Scudder Road, Pune-411037 Vellore-632004 Date of approval September 8, 2010 * Date of approval September 8, 2010 Total budget Rs 4, 85, 078 Total budget Rs 64, 14, 930 Duration 60 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

336 Building enteric infectious disease research capacity in India 339 Sensitivity and specificity of Mycobacterium tuberculosis screening and diagnostics in HIV infected individuals

Principal Investigator Funded by Principal Investigator Funded by Dr. Gagandeep Kang National Institutes of Health, USA Dr. Vignesh R National Institutes of Health, USA Professor, Coordinator, Christian Medical College & Hospital, Y R Gaitonde Centre for AIDS Ida Scudder Road, Research and Education (YRG CARE), Vellore-632004 Voluntary Health Services, Taramani, Date of approval September 8, 2010 Date of approval September 8, 2010 ** Chennai-600113 Total budget Rs 4, 46, 48, 820 Total budget Rs 13, 04,000 Duration 48 Months Duration 18 Months Subject area Diarrhoeal Diseases Subject area HIV/ Tuberculosis

* Final approval granted in HMSC meeting held on March 8, 2011 with conditions * Extension of project till July 2013, with no additional cost, approved in HMSC meeting held on June 18, 2012 ** Approved with suggestion

Indian Council of Medical Research 141 Indian Council of Medical Research 142

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

340 Monitoring and evaluation of HIV drug resistance in patients on antiretroviral therapy (TREAT Asia studies to evaluate resistance (TASER-M) Protocol)

Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Chief Medical Officer, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval September 8, 2010* Chennai-600113 Total budget Rs 18, 10,000 Duration 60 Months Subject area HIV/AIDS/ STD

341 Collaborative research on saliva-based biomarkers for oral cancer

Principal Investigator Funded by Dr. Ajoy Roy Choudhury National Institutes of Health, USA Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010* * Total budget Rs 5, 77, 83,719 Duration 60 Months Subject area Oncology

342 Drug resistance in different HIV-1 subtypes

Principal Investigator Funded by Dr. S Saravanan National Institutes of Health, USA Assistant Professor, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 8, 2010 ** Chennai-600113 Total budget Rs 79, 27, 872 Duration 60 Months Subject area HIV/AIDS/ STD

* Final approval granted in HMSC meeting held on March 8, 2011 with conditions ** Approved with conditions

143

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

340 Monitoring and evaluation of HIV drug resistance in patients on antiretroviral therapy (TREAT 343 Efficacy of varenicline for smokeless tobacco use in India Asia studies to evaluate resistance (TASER-M) Protocol)

Principal Investigator Funded by Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Dr. Raka Jain National Institutes of Health, USA Chief Medical Officer, Professor, Y R Gaitonde Centre for AIDS All India Institute of Medical Sciences Research and Education (YRG CARE), (AIIMS), Ansari Nagar, Voluntary Health Services, Taramani, New Delhi-110029 Date of approval September 8, 2010* Date of approval December 8, 2010 Chennai-600113 Total budget Rs 18, 10,000 Total budget Rs 59, 55, 896 Duration 60 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Life Style Diseases

341 Collaborative research on saliva-based biomarkers for oral cancer 344 HIV associated lipodystrophy syndrome in children: Role of nutrition, ART & genes

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajoy Roy Choudhury National Institutes of Health, USA Dr. Soumya Swaminathan National Institutes of Health, USA Associate Professor, Scientist G, All India Institute of Medical Sciences National Institute for Research in (AIIMS), Ansari Nagar, Tuberculosis (NIRT), Mayor V.R. Ramanathan Road, New Delhi-110029 ** Date of approval December 8, 2010 * Date of approval December 8, 2010 Chetput, Total budget Rs 5, 77, 83,719 Chennai-600031 Total budget Rs 45, 00, 000 Duration 60 Months Duration 48 Months Subject area Oncology Subject area HIV/AIDS/ STD

342 Drug resistance in different HIV-1 subtypes 345 Inspire Indian stroke prospective registry: A large multicentric prospective study to determine etiologies, clinical practice patterns and outcomes of strokes in India

Principal Investigator Funded by Principal Investigator Funded by Dr. S Saravanan National Institutes of Health, USA Dr. G R K Sharma National Institutes of Health, USA Assistant Professor, Director-in-Charge, Y R Gaitonde Centre for AIDS St. Johns Medical College, St. Johns Research and Education (YRG CARE), Research Institute, Voluntary Health Services, Taramani, St. Johns National Academy of Health Date of approval December 8, 2010 ** Date of approval December 8, 2010 ** Chennai-600113 Sciences, Total budget Rs 79, 27, 872 Koramangala, Sarjapur Road, Total budget Rs 1, 56, 19, 056 Bangalore-560034 Duration 60 Months Duration 36 Months Subject area HIV/AIDS/ STD Subject area Neurosciences

* Final approval granted in HMSC meeting held on March 8, 2011 with conditions * Approved with conditions and change of PI from Dr.C Padamapriyadarsini to Dr. Soumya Swaminathan in HMSC meeting held on March12, 2012 ** Approved with conditions ** Final approval granted in HMSC meeting held on September 8, 2011

Indian Council of Medical Research 143 144

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

346 Center for the Study of Complex Malaria in India (CSCMi)

Principal Investigator Funded by Dr. V K Dua National Institutes of Health, USA Scientist F, National Institute of Malaria Research (NIMR), Sector 8, Dwarka, New Delhi-110077 Date of approval March 8, 2011 Total budget Rs 17, 32, 70, 699 Duration 84 Months Subject area Malaria

347 Development of an international guide to monitor and support child development

Principal Investigator Funded by Dr. Vibha Krishnamurthy National Institutes of Health, USA Medical Director, Ummeed Child Development Center, 1-B, 1/62, Ground Floor, Mantri Pride, NM Joshi Marg, Subhash Nagar, Date of approval March 8, 2011 Lower Parel, Mumbai-400011 Total budget Rs 1, 78, 89, 030 Duration 60 Months Subject area Child Health

348 Epidemiology of novel human astroviruses

Principal Investigator Funded by Dr. Gagandeep Kang National Institutes of Health, USA Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval March 8, 2011 Total budget Rs 1, 35, 000 Duration 24 Months Subject area Other Infectious Diseases

Indian Council of Medical Research 145

Research Projects Approved by HMSC Research ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

346 Center for the Study of Complex Malaria in India (CSCMi) 349 Malaria evaluation in South Asia

Principal Investigator Funded by Principal Investigator Funded by Dr. V K Dua National Institutes of Health, USA Dr. Ashwani Kumar National Institutes of Health, USA Scientist F, Scientist E & Officer-in-Charge, National Institute of Malaria Research National Institute of Malaria Research (NIMR), Sector 8, Dwarka, (NIMR), Field Station, Panaji, New Delhi-110077 Goa-403001 Date of approval March 8, 2011 Date of approval March 8, 2011 Total budget Rs 17, 32, 70, 699 Total budget Rs 35, 34, 38, 235 Duration 84 Months Duration 84 Months Subject area Malaria Subject area Malaria

347 Development of an international guide to monitor and support child development 350 PREPARE - primary prevention strategies at the community level to promote treatment adherence to prevent cardiovascular diseases: A multi-centric household level cluster randomized trial

Principal Investigator Funded by Principal Investigator Funded by Dr. Vibha Krishnamurthy National Institutes of Health, USA Dr. Rajnish Joshi National Institutes of Health, USA Medical Director, Associate Professor, Ummeed Child Development Center, St. Johns Medical College, St. Johns 1-B, 1/62, Ground Floor, Mantri Pride, Research Institute, NM Joshi Marg, Subhash Nagar, St. Johns National Academy of Health Date of approval March 8, 2011 Date of approval March 8, 2011 Lower Parel, Sciences, Mumbai-400011 Total budget Rs 1, 78, 89, 030 Koramangala, Sarjapur Road, Total budget Rs 1, 49, 13, 053 Bangalore-560034 Duration 60 Months Duration 36 Months Subject area Child Health Subject area Cardiovascular Diseases Promoting maternal and infant survival everywhere, IMPAACT 1077BG, breastfeeding version 348 Epidemiology of novel human astroviruses 351 of the PROMISE study (Promoting Maternal and Infant Survival Everywhere) and substudy IMPAACT P1084s: Maternal and infant monitoring for evidence of toxicity related to tenofovir exposure: The bone and kidney health substudy of the PROMISE protocol Principal Investigator Funded by Principal Investigator Funded by Dr. Gagandeep Kang National Institutes of Health, USA Dr. A V Jamkar National Institutes of Health, USA Professor, Dean, Christian Medical College & Hospital, B J Medical College and Sassoon Ida Scudder Road, General Hospital, Vellore-632004 Jai Prakash Narayan Road, Date of approval March 8, 2011 Date of approval March 8, 2011 * Pune-411001 Total budget Rs 1, 35, 000 Total budget Rs 2, 97, 67, 373 Duration 24 Months Duration 60 Months Subject area Other Infectious Diseases Subject area Child Health

* Final approval granted by Chairman, HMSC on May 9, 2011 and endorsed in HMSC meeting held on June 8, 2011

Indian Council of Medical Research 145 146

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

352 Study of a novel picornavirus genus associated with acute flaccid paralysis

Principal Investigator Funded by Dr. T N Dhole National Institutes of Health, USA Professor & Head, Sanjay Gandhi Postgraduate Institute of Medical Sciences, PB No. 375, Raebareli Road, Date of approval March 8, 2011 Lucknow-226014 Total budget Rs 20, 60, 000 Duration 24 Months Subject area Other Infectious Diseases

353 Substituting brown rice for white rice: Effects on diabetes risk factors in India

Principal Investigator Funded by Dr. V Mohan National Institutes of Health, USA Director, Madras Diabetes Research Foundation, No-4, Conran Smith Road, Gopalapuram, Date of approval March 8, 2011* Chennai-600086 Total budget Rs 75, 78, 338 Duration 36 Months Subject area Diabetes

354 International health warning study and international tobacco packaging study: Evaluating industry marketing practices

Principal Investigator Funded by Dr. Prakash C Gupta National Institutes of Health, USA Director, Healis-Sekhasaria Institute for Public Health, 601/B, Great Eastern Chambers, Plot No. 28, Sector-11, Date of approval June 8, 2011 CBD Belapur, Mumbai-400614 Total budget Rs 6, 04, 800 Duration 6 Months Subject area Life Style Diseases

* Approved with suggestions

147

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

352 Study of a novel picornavirus genus associated with acute flaccid paralysis 355 Kerala - Einstein study: Healthy lifestyle, vascular disease and cognitive decline

Principal Investigator Funded by Principal Investigator Funded by Dr. T N Dhole National Institutes of Health, USA Dr. P S Mathuranath National Institutes of Health, USA Professor & Head, Associate Professor, Sanjay Gandhi Postgraduate Institute of Sree Chitra Tirunal Institute for Medical Medical Sciences, Sciences & Technology (SCTIMST), PB No. 375, Raebareli Road, (Trivandrum), Date of approval March 8, 2011 Date of approval June 8, 2011 * Lucknow-226014 Thiruvananthapuram-695011 Total budget Rs 20, 60, 000 Total budget Rs 3, 76, 71, 081 Duration 24 Months Duration 60 Months Subject area Other Infectious Diseases Subject area Neurosciences

353 Substituting brown rice for white rice: Effects on diabetes risk factors in India 356 Malaria research training in South India

Principal Investigator Funded by Principal Investigator Funded by Dr. V Mohan National Institutes of Health, USA Dr. Rajeshwara Achur National Institutes of Health, USA Director, Associate Professor & Chairman, Madras Diabetes Research Foundation, Kuvempu University, No-4, Conran Smith Road, Shankaraghatta, Gopalapuram, Shimoga-577451 Date of approval March 8, 2011* Date of approval June 8, 2011 Chennai-600086 Total budget Rs 75, 78, 338 Total budget Rs 1, 12, 10, 000 Duration 36 Months Duration 60 Months Subject area Diabetes Subject area Malaria

354 International health warning study and international tobacco packaging study: Evaluating industry 357 An exploratory analysis of NRGI contribution to Schizophrenia susceptibility among North marketing practices Indians - Re-entry funding for trainees

Principal Investigator Funded by Principal Investigator Funded by Dr. Prakash C Gupta National Institutes of Health, USA Dr. Smita N Deshpande National Institutes of Health, USA Director, Head of Department, Healis-Sekhasaria Institute for Public Dr. Ram Manohar Lohia Hospital, Health, 601/B, Great Eastern Baba Kharag Singh Marg, Chambers, Plot No. 28, Sector-11, New Delhi-110001 Date of approval June 8, 2011 Date of approval September 8, 2011* CBD Belapur, Mumbai-400614 Total budget Rs 6, 04, 800 Total budget Rs 56, 70,345 Duration 6 Months Duration 24 Months Subject area Life Style Diseases Subject area Mental Health

Approved with conditions * Approved with suggestions *

Indian Council of Medical Research 147 Indian Council of Medical Research 148

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

358 Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries (ACT)

Principal Investigator Funded by Dr. Archana Patel National Institutes of Health, USA Professor & Head, Lata Medical Research Foundation, Kinkine Kutir, Vasant Nagar Colony Near Deeksha Bhoomi Square Date of approval September 8, 2011 * Nagpur-440022 Total budget Rs 1, 02, 62, 340 Duration 24 Months Subject area Reproductive Health

359 Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries in Belgaum district, Karnataka

Principal Investigator Funded by Dr. Bhalachandra S Kodkany National Institutes of Health, USA Professor, Jawaharlal Nehru Medical College, JNMC Campus, Nehru Nagar, Belgaum-590010 Date of approval September 8, 2011* Total budget Rs 32, 89, 860 Duration 24 Months Subject area Reproductive Health

360 MTN-005: Expanded safety and adherence study of a non-medicated intravaginal ring

Principal Investigator Funded by Dr. Sanjay Mehendale National Institutes of Health, USA Scientist G & Director, National Institute of Epidemiology, R- 127, 3rd Avenue, Tamil Nadu Housing Board, Ayapakkam, Date of approval September 8, 2011 ** Chennai-600077 Total budget Rs 1, 28, 89, 059 Duration 60 Months Subject area HIV/AIDS/ STD

* Approved with conditions ** The decision of premature closure of the study by Indian PI was noted by HMSC in its meeting held on December 10, 2012

149

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

358 Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing 361 Radiosurgery vs. Lobectomy for temporal lobe epilepsy (ROSE) countries (ACT)

Principal Investigator Funded by Principal Investigator Funded by Dr. Archana Patel National Institutes of Health, USA Dr. Ashok Mahapatra National Institutes of Health, USA Professor & Head, Professor & Head, Lata Medical Research Foundation, All India Institute of Medical Sciences Kinkine Kutir, Vasant Nagar Colony (AIIMS), Ansari Nagar, New Delhi-110029 Near Deeksha Bhoomi Square Date of approval September 8, 2011 * Date of approval September 8, 2011 Nagpur-440022 Total budget Rs 1, 02, 62, 340 Total budget Rs 2, 50, 00, 000 Duration 24 Months Duration 36 Months Subject area Reproductive Health Subject area Neurosciences

359 Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing 362 Reducing early mortality and early morbidity by empiric tuberculosis treatment regimens countries in Belgaum district, Karnataka

Principal Investigator Funded by Principal Investigator Funded by Dr. Bhalachandra S Kodkany National Institutes of Health, USA Dr. Renu Bharadwaj National Institutes of Health, USA Professor, Professor & Head, Jawaharlal Nehru Medical College, B J Medical College and Sassoon JNMC Campus, Nehru Nagar, General Hospital, Belgaum-590010 * Jai Prakash Narayan Road, Date of approval September 8, 2011 Date of approval September 8, 2011 * Pune-411001 Total budget Rs 32, 89, 860 Total budget Rs 40, 03, 587 Duration 24 Months Duration 24 Months Subject area Reproductive Health Subject area Tuberculosis

360 MTN-005: Expanded safety and adherence study of a non-medicated intravaginal ring 363 Reducing early mortality and early morbidity by empiric tuberculosis treatment regimens

Principal Investigator Funded by Principal Investigator Funded by Dr. Sanjay Mehendale National Institutes of Health, USA Dr. N Kumarasamy National Institutes of Health, USA Scientist G & Director, Chief Medical Officer, National Institute of Epidemiology, R- Y R Gaitonde Centre for AIDS 127, 3rd Avenue, Tamil Nadu Housing Research and Education (YRG CARE), Board, Ayapakkam, Voluntary Health Services, Taramani, Date of approval September 8, 2011 ** Date of approval September 8, 2011 * Chennai-600077 Chennai-600113 Total budget Rs 1, 28, 89, 059 Total budget Rs 70, 86, 791 Duration 60 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Tuberculosis

* Approved with conditions * Approved with conditions ** The decision of premature closure of the study by Indian PI was noted by HMSC in its meeting held on December 10, 2012

Indian Council of Medical Research 149

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

364 Vanderbilt - NARI - NIE informatics training program

Principal Investigator Funded by Dr. Jayanta Bhattacharya National Institutes of Health, USA Scientist D, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval September 8, 2011 * Pune-411026 Total budget Rs 1, 09, 17, 540 (per year) Duration 60 Months Subject area Bioinformatics

365 A5282: A randomized, phase II trial to compare an HPV test-and-treat strategy to a cytology based strategy for prevention of CIN 2+ in HIV-infected women

Principal Investigator Funded by Dr. Ajay Chandanwale National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval December 8, 2011 Pune-411001 Total budget Rs 1, 17, 57, 136 Duration 36 Months Subject area HIV/AIDS/ STD

366 ACTG 5274: Reducing early mortality and early morbidity by empiric tuberculosis treatment regimens

Principal Investigator Funded by Dr. Srikanth P Tripathy National Institutes of Health, USA Scientist F, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval December 8, 2011** Pune-411026 Total budget Rs 70, 50, 179 Duration 96 Months Subject area HIV/ Tuberculosis

* Approved with conditions ** Approved with suggestions

151

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

364 Vanderbilt - NARI - NIE informatics training program 367 ACTG 5282: A randomized, phase II trial to compare an HPV test-and-treat strategy to a cytology based strategy for prevention of CIN 2+ in HIV infected women

Principal Investigator Funded by Principal Investigator Funded by Dr. Jayanta Bhattacharya National Institutes of Health, USA Dr. Srikanth P Tripathy National Institutes of Health, USA Scientist D, Scientist F, National AIDS Research Institute (NARI), National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, 73 G Block, MIDC, Bhosari, Post Box No. 1875, Post Box No. 1875, Date of approval September 8, 2011 * Date of approval December 8, 2011 * Pune-411026 Pune-411026 Total budget Rs 1, 09, 17, 540 (per year) Total budget Rs 28, 66,195 Duration 60 Months Duration 36 Months Subject area Bioinformatics Subject area HIV/AIDS/ STD

365 A5282: A randomized, phase II trial to compare an HPV test-and-treat strategy to a cytology 368 ACTG5271: Collection of comparison neurocognitive data in resource limited settings based strategy for prevention of CIN 2+ in HIV-infected women

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajay Chandanwale National Institutes of Health, USA Dr. Srikanth P Tripathy National Institutes of Health, USA Dean, Scientist F, B J Medical College and Sassoon National AIDS Research Institute (NARI), General Hospital, 73 G Block, MIDC, Bhosari, Jai Prakash Narayan Road, Post Box No. 1875, Date of approval December 8, 2011 Date of approval December 8, 2011* Pune-411001 Pune-411026 Total budget Rs 1, 17, 57, 136 Total budget Rs 5, 94, 000 Duration 36 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

366 ACTG 5274: Reducing early mortality and early morbidity by empiric tuberculosis treatment 369 Assessment of causality between exposure to tobacco use in Bollywood movies and tobacco use regimens among Indian adolescents

Principal Investigator Funded by Principal Investigator Funded by Dr. Srikanth P Tripathy National Institutes of Health, USA Dr. Monika Arora National Institutes of Health, USA Scientist F, Director, National AIDS Research Institute (NARI), Health Related Information Dissemination, 73 G Block, MIDC, Bhosari, Amongst Youth (HRIDAY), Post Box No. 1875, Safdarjung Development Area, Date of approval December 8, 2011** Date of approval December 8, 2011 Pune-411026 New Delhi-110016 Total budget Rs 70, 50, 179 Total budget Rs 49, 61, 952 Duration 96 Months Duration 24 Months Subject area HIV/ Tuberculosis Subject area Life Style Diseases

* Approved with conditions * Approved with suggestions ** Approved with suggestions

Indian Council of Medical Research 151

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

370 A 5265: A Phase III, open-label, randomized, assessment - blinded clinical trial to compare the safety and efficacy of topical gentian violent to that of nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 infected participants

Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval December 8, 2011 Pune-411001 Total budget Rs 79, 34, 879 Duration 6 Months Subject area HIV/AIDS/ STD

371 A 5265: A Phase III, open-label, randomized, assessment - blinded clinical trial to compare the safety and efficacy of topical gentian violent to that of nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 infected participants

Principal Investigator Funded by Dr. K Ranganathan National Institutes of Health, USA Research Director, Dental Research Foundation-Chennai, 6th Floor, Mylapore, Chennai-60004 Date of approval December 8, 2011 Total budget Rs 13, 15, 000 Duration 6 Months Subject area HIV/AIDS/ STD

372 ACTG 5265: A Phase III, open-label, randomized, assessment-blinded clinical trial to compare the safety and efficacy of topical gentian violet to that of nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 infected participants Principal Investigator Funded by Dr. Srikanth P Tripathy National Institutes of Health, USA Scientist F, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval December 8, 2011 Pune-411026 Total budget Rs 1, 95, 04, 000 Duration 6 Months Subject area HIV/AIDS/ STD

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

370 A 5265: A Phase III, open-label, randomized, assessment - blinded clinical trial to compare the 373 Community volunteers, solidarity and case management of tuberculosis safety and efficacy of topical gentian violent to that of nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 infected participants

Principal Investigator Funded by Principal Investigator Funded by Dr. Arun Jamkar National Institutes of Health, USA Dr. Soumya Swaminathan National Institutes of Health, USA Dean, Scientist G, B J Medical College and Sassoon National Institute for Research in General Hospital, Tuberculosis (NIRT), Jai Prakash Narayan Road, Mayor V.R. Ramanathan Road, Date of approval December 8, 2011 Date of approval December 8, 2011 Pune-411001 Chetput, Total budget Rs 79, 34, 879 Chennai-600031 Total budget Rs 3, 71, 41, 819 Duration 6 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Tuberculosis

371 A 5265: A Phase III, open-label, randomized, assessment - blinded clinical trial to compare the 374 HIV, HCV and liver disease among injection drug users in Chennai safety and efficacy of topical gentian violent to that of nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1 infected participants

Principal Investigator Funded by Principal Investigator Funded by Dr. K Ranganathan National Institutes of Health, USA Dr. Suniti Solomon National Institutes of Health, USA Research Director, Director, Dental Research Foundation-Chennai, Y R Gaitonde Centre for AIDS 6th Floor, Mylapore, Research and Education (YRG CARE), Chennai-60004 Voluntary Health Services, Taramani, * Date of approval December 8, 2011 Date of approval December 8, 2011 Chennai-600113 Total budget Rs 13, 15, 000 Total budget Rs 6, 21, 80,939 Duration 6 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

372 ACTG 5265: A Phase III, open-label, randomized, assessment-blinded clinical trial to compare 375 IMPAACT 1077FF Formula Feeding version of the PROMISE study: Promoting maternal and the safety and efficacy of topical gentian violet to that of nystatin oral suspension for the infant survival everywhere treatment of oropharyngeal candidiasis in HIV-1 infected participants Principal Investigator Funded by Principal Investigator Funded by Dr. Srikanth P Tripathy National Institutes of Health, USA Dr. Renu Bhardwaj National Institutes of Health, USA Scientist F, Professor & Head, National AIDS Research Institute (NARI), B J Medical College and Sassoon 73 G Block, MIDC, Bhosari, General Hospital, Post Box No. 1875, Jai Prakash Narayan Road, Date of approval December 8, 2011 Date of approval December 8, 2011* * Pune-411026 Pune-411001 Total budget Rs 1, 95, 04, 000 Total budget Rs 2, 88, 54, 456 Duration 6 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Child Health

* Approved with conditions ** Clarifications found satisfactory, approved and endorsed in HMSC meeting held on March 12, 2012

Indian Council of Medical Research 153 Indian Council of Medical Research 154

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

376 Intervention to fight anemia and improve well being in a very low income setting

Principal Investigator Funded by Dr. Sharon Barnhardt National Institutes of Health, USA Assistant Professor, Institute for Financial Management and Research, 24 Kothari Road, Nungambakkam, Date of approval December 8, 2011 Chennai-600034 Total budget Rs 1, 16, 18, 584 Duration 60 Months Subject area Nutrition

377 Innate immune and inflammatory gene polymorphisms in Cryptosporidiosis in South India

Principal Investigator Funded by Dr. Sitara Rao National Institutes of Health, USA Associate Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval December 8, 2011 Total budget Rs 1, 20, 16, 800 Duration 60 Months Subject area Diarrhoeal Diseases

378 Integrated care clinics for IDUS in India: A cluster randomized trial

Principal Investigator Funded by Dr. Suresh Kumar National Institutes of Health, USA Consultant, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval December 8, 2011 Chennai-600113 Total budget Rs 24, 79, 71, 000 Duration 60 Months Subject area HIV/AIDS/ STD

155

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

376 Intervention to fight anemia and improve well being in a very low income setting 379 Multicenter study of options for Second Line Effective Combination Therapy (SELECT), a multicenter trial of the AIDS Clinical Trials Group (ACTG)

Principal Investigator Funded by Principal Investigator Funded by Dr. Sharon Barnhardt National Institutes of Health, USA Dr. N Kumarasamy National Institutes of Health, USA Assistant Professor, Chief Medical Officer, Institute for Financial Management and Y R Gaitonde Centre for AIDS Research, 24 Kothari Road, Research and Education (YRG CARE), Nungambakkam, Voluntary Health Services, Taramani, Date of approval December 8, 2011 Date of approval December 8, 2011 Chennai-600034 Chennai-600113 Total budget Rs 1, 16, 18, 584 Total budget Rs 1, 16, 99, 594 Duration 60 Months Duration 12 Months Subject area Nutrition Subject area HIV/AIDS/ STD

377 Innate immune and inflammatory gene polymorphisms in Cryptosporidiosis in South India 380 Preventing HIV among MSM in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Sitara Rao National Institutes of Health, USA Dr. Suniti Solomon National Institutes of Health, USA Associate Professor, Director, Christian Medical College & Hospital, Y R Gaitonde Centre for AIDS Ida Scudder Road, Research and Education (YRG CARE), Vellore-632004 Voluntary Health Services, Taramani, Date of approval December 8, 2011 Date of approval December 8, 2011 Chennai-600113 Total budget Rs 1, 20, 16, 800 Total budget Rs 7, 92, 63,000 Duration 60 Months Duration 60 Months Subject area Diarrhoeal Diseases Subject area HIV/AIDS/ STD

378 Integrated care clinics for IDUS in India: A cluster randomized trial 381 Surgical Treatment for Ischemic Heart Failure Extended Study (STICHES)

Principal Investigator Funded by Principal Investigator Funded by Dr. Suresh Kumar National Institutes of Health, USA Dr. D Prabhakaran National Institutes of Health, USA Consultant, Executive Director, Y R Gaitonde Centre for AIDS Center for Chronic Disease Control Research and Education (YRG CARE), (CCDC), C1/52, Second Floor, Voluntary Health Services, Taramani, Safdarjung Development Area, Date of approval December 8, 2011 Date of approval December 8, 2011* Chennai-600113 New Delhi-110016 Total budget Rs 24, 79, 71, 000 Total budget Rs 92, 25,000 Duration 60 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Cardiovascular Diseases

* Approved for 7 study sites only

Indian Council of Medical Research 155 156

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

382 US-India Collaborative Partnership in Parkinson Disease (CPPD)

Principal Investigator Funded by Dr. Madhuri Behari National Institutes of Health, USA (funded by DBT, Govt. of India) Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2011* Total budget Rs 22, 75, 46, 000 Duration 24 Months Subject area Neurosciences

383 A5279: Phase III clinical trial of ultra-short-course Rifapentine / Isoniazid for the prevention of active tuberculosis in HIV - infected individuals with latent tuberculosis infection

Principal Investigator Funded by Dr. Ajay Chandanwale National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval March 12, 2012 Pune-411001 Total budget Rs 2, 39, 69, 646 Duration 36 Months Subject area HIV/ Tuberculosis

384 A5279: Phase III clinical trial of ultra-short-course Rifapentine / Isoniazid for the prevention of active tuberculosis in HIV - infected individuals with latent tuberculosis infection

Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Chief Medical Officer, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval March 12, 2012 Chennai-600113 Total budget Rs 62, 15, 692 Duration 50 Months Subject area HIV/ Tuberculosis

* Approved with conditions

157

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

382 US-India Collaborative Partnership in Parkinson Disease (CPPD) 385 A5279: Phase III clinical trial of ultra-short-course Rifapentine / Isoniazid for the prevention of active tuberculosis in HIV - infected individuals with latent tuberculosis infection

Principal Investigator Funded by Principal Investigator Funded by Dr. Madhuri Behari National Institutes of Health, USA (funded by Dr. Srikanth P Tripathy National Institutes of Health, USA DBT, Govt. of India) Professor, Scientist F, All India Institute of Medical Sciences National AIDS Research Institute (AIIMS), Ansari Nagar, (NARI), 73 G Block, MIDC, Bhosari, New Delhi-110029 Post Box No. 1875, Date of approval December 8, 2011* Date of approval March 12, 2012 Pune-411026 Total budget Rs 22, 75, 46, 000 Total budget Rs 99, 35,746 Duration 24 Months Duration 36 Months Subject area Neurosciences Subject area HIV/ Tuberculosis

383 A5279: Phase III clinical trial of ultra-short-course Rifapentine / Isoniazid for the prevention of 386 Evaluation of helping babies breathe in Belgaum, Kenya and Nagpur: Does implementation of active tuberculosis in HIV - infected individuals with latent tuberculosis infection helping babies breathe save lives?

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajay Chandanwale National Institutes of Health, USA Dr. Shivaprasad S Goudar National Institutes of Health, USA Dean, Professor & Head, B J Medical College and Sassoon Jawaharlal Nehru Medical College, General Hospital, JNMC Campus, Nehru Nagar, Jai Prakash Narayan Road, Belgaum-590010 Date of approval March 12, 2012 Date of approval March 12, 2012 Pune-411001 Total budget Rs 2, 39, 69, 646 Total budget Rs 2, 73, 91, 000 Duration 36 Months Duration 24 Months Subject area HIV/ Tuberculosis Subject area Child Health

384 A5279: Phase III clinical trial of ultra-short-course Rifapentine / Isoniazid for the prevention of 387 Evaluation of helping babies breathe in Belgaum, Kenya and Nagpur: Does implementation of active tuberculosis in HIV - infected individuals with latent tuberculosis infection helping babies breathe save lives?

Principal Investigator Funded by Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Dr. Archana Patel National Institutes of Health, USA Chief Medical Officer, Professor & Head, Y R Gaitonde Centre for AIDS Lata Medical Research Foundation, Research and Education (YRG CARE), Kinkine Kutir, Vasant Nagar Colony, Voluntary Health Services, Taramani, Near Deeksha Bhoomi Square, Date of approval March 12, 2012 Date of approval March 12, 2012 Chennai-600113 Nagpur-440022 Total budget Rs 62, 15, 692 Total budget Rs 2, 47, 72, 386 Duration 50 Months Duration 24 Months Subject area HIV/ Tuberculosis Subject area Child Health

* Approved with conditions

Indian Council of Medical Research 157 Indian Council of Medical Research 158

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

388 HIV / AIDS and orphan care / positive outcomes for orphans

Principal Investigator Funded by Dr. Neville Selhore National Institutes of Health, USA Director, Sahara House Centre for Residential Care and Rehabilitation, E-453, Greater Kailash-1, Date of approval March 12, 2012 New Delhi-110048 Total budget Rs 1, 69, 72,120 Duration 48 Months Subject area HIV/AIDS/ STD

389 Metabolic characteristics of lean diabetes in rural and semi-urban India

Principal Investigator Funded by Dr. Nihal Thomas National Institutes of Health, USA Head & Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval March 12, 2012* Total budget Rs 11, 76, 355 Duration 36 Months Subject area Diabetes

390 Strategic Timing of Antiretroviral Treatment (START) - Insight Protocol 001: START

Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Chief Medical Officer, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval March 12, 2012* Chennai-600113 Total budget Rs 78, 43,116 Duration 72 Months Subject area HIV/AIDS/ STD

* Approved with conditions

159

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

388 HIV / AIDS and orphan care / positive outcomes for orphans 391 Stroke risk in Indians: an Indo-US collaborative study

Principal Investigator Funded by Principal Investigator Funded by Dr. Neville Selhore National Institutes of Health, USA Dr. S. K Das National Institutes of Health, USA Director, Professor & Head, Sahara House Centre for Residential Bangur Institute of Neuroscience Care and Rehabilitation, (BIN), 52/1A Shambunath Pandit E-453, Greater Kailash-1, Road, Kolkata-700025 Date of approval March 12, 2012 Date of approval March 12, 2012 New Delhi-110048 Total budget Rs 1, 69, 72,120 Total budget Rs 3, 02, 67, 735 Duration 48 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Neurosciences

389 Metabolic characteristics of lean diabetes in rural and semi-urban India 392 Visceral Leishmaniasis in Bihar State, India

Principal Investigator Funded by Principal Investigator Funded by Dr. Nihal Thomas National Institutes of Health, USA Dr. Shyam Sundar National Institutes of Health, USA Head & Professor, Professor, Christian Medical College & Hospital, Institute of Medical Sciences, Ida Scudder Road, Banaras Hindu University, Vellore-632004 Varanasi-221005 Date of approval March 12, 2012* Date of approval March 12, 2012 * Total budget Rs 11, 76, 355 Total budget Rs 14, 31, 27,150 Duration 36 Months Duration 60 Months Subject area Diabetes Subject area Leishmaniasis

390 Strategic Timing of Antiretroviral Treatment (START) - Insight Protocol 001: START 393 Share: South Asian hub for advocacy, research and education in mental health

Principal Investigator Funded by Principal Investigator Funded by Dr. N Kumarasamy National Institutes of Health, USA Dr. Vikram Patel National Institutes of Health, USA Chief Medical Officer, Professor, Y R Gaitonde Centre for AIDS Sangath Centre, Research and Education (YRG CARE), 841/1 Alto Porvorim, Voluntary Health Services, Taramani, Goa-403521 Date of approval March 12, 2012* Date of approval March 12, 2012 ** Chennai-600113 Total budget Rs 78, 43,116 Total budget Rs 10, 34, 82,165 Duration 72 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Mental Health

* Approved with conditions * Approved with conditions ** Approved for phase I part of study only and there should be a midterm appraisal of the study

Indian Council of Medical Research 159 160

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

394 A5273: Multicenter study of options for Second-Line Effective Combination Therapy (SELECT)

Principal Investigator Funded by Dr. Ajay Chandanwale National Institutes of Health, USA Dean, B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Date of approval June 18, 2012 Pune-411001 Total budget Rs 42, 26, 640 Duration 24 Months Subject area HIV/AIDS/ STD

395 A5273: Multicenter study of options for Second-Line Effective Combination Therapy (SELECT)

Principal Investigator Funded by Dr. Raman Gangakhedkar National Institutes of Health, USA Scientist E, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval June 18, 2012 Pune-411026 Total budget Rs 31, 86,183 Duration 24 Months Subject area HIV/AIDS/ STD

396 Cervical cancer prevention in HIV infected women in Pune: Evaluation of screening tests based on p16INK4a expression and evaluation of cold coagulation as a treatment option for cervical intraepithelial neoplasia for prevention of cervical cancer in HIV infected women

Principal Investigator Funded by Dr. Smita Joshi National Institutes of Health, USA Principal Investigator, Amrita Clinic, Athawale Corner Bulding, Near Sambhaji Bridge, Karve Road, Date of approval June 18, 2012 Pune-411004 Total budget Rs 46, 67, 509 Duration 24 Months Subject area HIV/AIDS/ STD

161

Research Projects Approved by HMSC Research ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

394 A5273: Multicenter study of options for Second-Line Effective Combination Therapy (SELECT) 397 Cross-cultural reliability and validity of intermediate measures (CIM II) of the measurement and treatment research to improve cognition in Schizophrenia (MATRICS)

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajay Chandanwale National Institutes of Health, USA Dr. J K Trivedi National Institutes of Health, USA Dean, Professor, B J Medical College and Sassoon Chhatrapati Shahuji Maharaj Medical General Hospital, University, (Erstwhile King George Jai Prakash Narayan Road, Medical College), Date of approval June 18, 2012 Date of approval June 18, 2012 Pune-411001 Chowk, Total budget Rs 42, 26, 640 Lucknow-226003 Total budget Rs 69,600 per patient Duration 24 Months Duration 12 Months Subject area HIV/AIDS/ STD Subject area Mental Health

395 A5273: Multicenter study of options for Second-Line Effective Combination Therapy (SELECT) 398 Early psychosis in India and Canada: Investigating outcomes and family factors

Principal Investigator Funded by Principal Investigator Funded by Dr. Raman Gangakhedkar National Institutes of Health, USA Dr. R Thara National Institutes of Health, USA Scientist E, Director, National AIDS Research Institute (NARI), Schizophrenia Research Foundation 73 G Block, MIDC, Bhosari, (SCARF), R/7 A North Main Road, Post Box No. 1875, Anna Nagar West Extention, Date of approval June 18, 2012 Date of approval June 18, 2012 Pune-411026 Chennai-600101 Total budget Rs 31, 86,183 Total budget Rs 1, 89, 45,716 Duration 24 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Mental Health

396 Cervical cancer prevention in HIV infected women in Pune: Evaluation of screening tests based 399 Impact of malaria co - infection on HIV- associated neurocognitive disorders on p16INK4a expression and evaluation of cold coagulation as a treatment option for cervical intraepithelial neoplasia for prevention of cervical cancer in HIV infected women

Principal Investigator Funded by Principal Investigator Funded by Dr. Smita Joshi National Institutes of Health, USA Dr. N Kumarasamy National Institutes of Health, USA Principal Investigator, Chief Medical Officer, Amrita Clinic, Y R Gaitonde Centre for AIDS Athawale Corner Bulding, Research and Education (YRG CARE), Near Sambhaji Bridge, Karve Road, Voluntary Health Services, Taramani, Date of approval June 18, 2012 Date of approval June 18, 2012 Pune-411004 Chennai-600113 Total budget Rs 46, 67, 509 Total budget Rs 14, 73, 553 Duration 24 Months Duration 48 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

Indian Council of Medical Research 161 162

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

400 Transcriptional analysis of the guinea pig model of Tuberculosis

Principal Investigator Funded by Dr. Raja Mugasimangalam National Institutes of Health, USA Chief Executive Officer, Genotype Technology, (P) 259 Apurva, 4th Cross 80 Feet Road, Date of approval June 18, 2012 Bangalaore-560094 Total budget Rs 27, 00, 000 Duration 24 Months Subject area Tuberculosis

401 Strategic Timing of Antiretroviral Treatment (START)

Principal Investigator Funded by Dr. Sanjay Pujari National Institutes of Health, USA Director & Chief Consultant, DirectorInstitute of& ChiefInfectious Con sultant,Diseases, Kumar Business Court, D Wing, Mukundnagar, Date of approval June 18, 2012 * Pune-411037 Total budget Rs 10, 21, 680 Duration 72 Months Subject area HIV/AIDS/ STD

402 A cluster-randomized trial to evaluate the effects of a simplified cardiovascular management program in China and India (SIMCARD)

Principal Investigator Funded by Dr. Ajay S Vamadevan National Institutes of Health, USA Senior Research Fellow, Centre, of Excellence - CARRS PHFI, CDirector-1/52, 2nd & Chief floor, Consultant, Safdarjung Development Area, Date of approval September 10, 2012 New Delhi-110016 Total budget Rs 82, 34, 040 Duration 24 Months Subject area Cardiovascular Diseases

* Approved with conditions

163

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

400 Transcriptional analysis of the guinea pig model of Tuberculosis 403 Capacity building of volunteer adolescent peer leaders for promoting effective reduction in early marriage and early pregnancy among rural unmarried adolescents in Maharashtra

Principal Investigator Funded by Principal Investigator Funded by Dr. Raja Mugasimangalam National Institutes of Health, USA Dr. Balaiah Donta National Institutes of Health, USA Chief Executive Officer, Scientist F, Genotype Technology, National Institute for Research in (P) 259 Apurva, Reproductive Health (NIRRH), 4th Cross 80 Feet Road, Jehangir Merwanji Road, Parel, Date of approval June 18, 2012 Date of approval September 10, 2012* Bangalaore-560094 Mumbai-400012 Total budget Rs 27, 00, 000 Total budget Rs 18, 00, 310 Duration 24 Months Duration 12 Months Subject area Tuberculosis Subject area Reproductive Health

401 Strategic Timing of Antiretroviral Treatment (START) 404 Effect of FADS gene variants on fatty acid synthesis and brain development in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Sanjay Pujari National Institutes of Health, USA Dr.Suchetha Kumari National Institutes of Health, USA Director & Chief Consultant, Professor, DirectorInstitute of& ChiefInfectious Con sultant,Diseases, K. S. Hegde Medical Academy, Kumar Business Court, NITTE University, Deralakatte, D Wing, Mukundnagar, Mangalore-575018 Date of approval June 18, 2012 * Date of approval September 10, 2012 Pune-411037 Total budget Rs 10, 21, 680 Total budget Rs 36, 22, 072 Duration 72 Months Duration 24 Months Subject area HIV/AIDS/ STD Subject area Neurosciences

402 A cluster-randomized trial to evaluate the effects of a simplified cardiovascular management 405 Effect of filarial infection on antigen-specific immune responses in latent tuberculosis in South program in China and India (SIMCARD) India

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajay S Vamadevan National Institutes of Health, USA Dr. P Paul Kumaran National Institutes of Health, USA Senior Research Fellow, Scientist D, Centre, of Excellence - CARRS PHFI, ,National Institute for Research in CDirector-1/52, 2nd & Chief floor, Consultant, Tuberculosis (NIRT), Safdarjung Development Area, Mayor V.R. Ramanathan Road, Date of approval September 10, 2012 Date of approval September 10, 2012 New Delhi-110016 Chetput, Total budget Rs 82, 34, 040 Chennai-600031 Total budget Rs 22, 00, 000 Duration 24 Months Duration 36 Months Subject area Cardiovascular Diseases Subject area Filariasis

* Approved with conditions * Approved with conditions

Indian Council of Medical Research 163

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

406 Enhancing HIV treatment adherence in South India: The Chetana study

Principal Investigator Funded by Dr. Sara Chandy National Institutes of Health, USA Assistant Professor, St. Johns Medical College and Institute of Population Health and Clinical Research (IPHCR), St. Johns National Date of approval September 10, 2012* Academy of Health Sciences, Banglare-560034 Total budget Rs 4, 35, 55, 092 Duration 60 Months Subject area HIV/AIDS/ STD

407 First-line Anti metabolities as Steroid Sparing Treatment (FAST) uveitis trial

Principal Investigator Funded by Dr. S R Rathinam National Institutes of Health, USA Head of Uveitis Service, Aravind Eye Hospital & PG Institute of Ophthalmology, 1, Annanagar, Date of approval September 10, 2012 Madurai-625020 Total budget Rs 80, 86, 582 Duration 60 Months Subject area Ophthalmology

408 High density lipoprotein cholesterol and gene polymorphisms among HIV infected South Indians on first line antiretroviral therapy

Principal Investigator Funded by Dr. C Padmapriyadarsini National Institutes of Health, USA Scientist D, National Institute for Research in Tuberculosis (NIRT), Mayor V.R. Ramanathan Road, Date of approval September 10, 2012 Chetput, Chennai-600031 Total budget Rs 7, 50, 000 Duration 12 Months Subject area HIV/AIDS/ STD

* Approved with conditions

165

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

406 Enhancing HIV treatment adherence in South India: The Chetana study 409 The impact of microfinance on health: Evidence from India

Principal Investigator Funded by Principal Investigator Funded by Dr. Sara Chandy National Institutes of Health, USA Dr. Ajay Tannirkulam National Institutes of Health, USA Assistant Professor, Executive Director, St. Johns Medical College and Institute Centre for Micro Finance, of Population Health and Clinical 8th Floor West Wing, Fountain Plaza, Research (IPHCR), St. Johns National Khaleel Shirazi Estate, Date of approval September 10, 2012* Date of approval September 10, 2012 * Academy of Health Sciences, 31/2A, Pantheon Road Egmore, Banglare-560034 Total budget Rs 4, 35, 55, 092 Chennai-600008 Total budget Rs 3, 72, 693 Duration 60 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Health Systems Research

407 First-line Anti metabolities as Steroid Sparing Treatment (FAST) uveitis trial 410 Indian sub project: Comparison of the genetic correlates of HIV / AIDS progression that predict viral induced neurologic dysfunction in HIV - 1 subtype C and subtype B Comprehensive NeuroAIDS Core Centre (CNACC)

Principal Investigator Funded by Principal Investigator Funded by Dr. S R Rathinam National Institutes of Health, USA Dr. Nirmala Rajagopalan National Institutes of Health, USA Head of Uveitis Service, Senior Physician, Aravind Eye Hospital & PG Institute of Freedom Foundation, Ophthalmology, 1st Street HBR layour, 1, Annanagar, Bangalore-560043 Date of approval September 10, 2012 Date of approval September 10, 2012 Madurai-625020 Total budget Rs 80, 86, 582 Total budget Rs 1, 25, 16, 100 Duration 60 Months Duration 60 Months Subject area Ophthalmology Subject area HIV/AIDS/ STD

408 High density lipoprotein cholesterol and gene polymorphisms among HIV infected South Indians 411 Alcohol and ART Adherence: Assessment, Intervention and Modelling (AIM) in India on first line antiretroviral therapy

Principal Investigator Funded by Principal Investigator Funded by Dr. C Padmapriyadarsini National Institutes of Health, USA Dr. Niranjan Saggurti National Institutes of Health, USA Scientist D, Project Director, National Institute for Research in Population Council, Tuberculosis (NIRT), 142 Golf Links, Mayor V.R. Ramanathan Road, New Delhi-110003 Date of approval September 10, 2012 Date of approval December 10, 2012 ** Chetput, Chennai-600031 Total budget Rs 7, 50, 000 Total budget Rs 6, 33, 26, 125 Duration 12 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Approved with conditions * The study was approved with conditions to ensure transfer of technology to Indian lab. The approval was withdrawn in HMSC meeting held on December 10, 2012 since PI did not agree to the conditions ** Approved with conditions Approved with conditions

Indian Council of Medical Research 165 166

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

412 ASHA improving health and nutrition of Indian women with AIDS and their children

Principal Investigator Funded by Dr. Sanjeev Sinha National Institutes of Health, USA Associate Professor, ,All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 10, 2012 * Total budget Rs 3, 64, 48,763 Duration 60 Months Subject area HIV/AIDS/ STD

413 Reducing AIDS stigma among health professionals in India

Principal Investigator Funded by Dr. Krishnamachari Srinivasan National Institutes of Health, USA Dean, St. Johns Medical College, St. Johns Research Institute, St. Johns National Academy of Health Date of approval December 10, 2012 * Sciences, Koramangala, Sarjapur Road, Total budget Rs 5, 10, 34,962 Bangalore-560034 Duration 60 Months Subject area HIV/AIDS/ STD

414 Social network positional selection of peer change agents

Principal Investigator Funded by Dr. Rakhi Dandona National Institutes of Health, USA Additional Professor, Public Health Foundation of India, ISID Campus 4 Institutional Area, Vasant Kunj, Date of approval December 10, 2012 New Delhi-110070 Total budget Rs 44, 25,000 Duration 24 Months Subject area HIV/AIDS/ STD

* Approved with conditions

Indian Council of Medical Research 167

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

412 ASHA improving health and nutrition of Indian women with AIDS and their children 415 The impact of diabetes on TB treatment outcomes

Principal Investigator Funded by Principal Investigator Funded by Dr. Sanjeev Sinha National Institutes of Health, USA Dr. Tilak Dhamgaye National Institutes of Health, USA Associate Professor, Professor & Head, ,All India Institute of Medical Sciences B J Medical College and Sassoon (AIIMS), Ansari Nagar, General Hospital, New Delhi-110029 Jai Prakash Narayan Road, Date of approval December 10, 2012 * Date of approval December 10, 2012 Pune-411001 Total budget Rs 3, 64, 48,763 Total budget Rs 4, 76, 21,775 Duration 60 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Tuberculosis

413 Reducing AIDS stigma among health professionals in India 416 First episode psychosis in South India

Principal Investigator Funded by Principal Investigator Funded by Dr. Krishnamachari Srinivasan National Institutes of Health, USA Dr. R Thara National Institutes of Health, USA and Canadian Institutes of Health Research (CIHR), Canada Dean, Director, St. Johns Medical College, St. Johns Schizophrenia Research Foundation Research Institute, (SCARF), R/7 A North Main Road, St. Johns National Academy of Health Anna Nagar, West Extention, Date of approval December 10, 2012 * Date of approval September 8, 2009 Sciences, Chennai-600101 Koramangala, Sarjapur Road, Total budget Rs 5, 10, 34,962 Total budget Rs 23, 10, 525 Bangalore-560034 Duration 60 Months Duration 60 Months Subject area HIV/AIDS/ STD Subject area Mental Health

414 Social network positional selection of peer change agents 417 Effects of maternal iodine supplementation in an area of mild iodine deficiency on infant development to 2 years

Principal Investigator Funded by Principal Investigator Funded by Dr. Rakhi Dandona National Institutes of Health, USA Dr. Krishnamachari Srinivasan Nestle Foundation, Switzerland Additional Professor, Vice Dean, Public Health Foundation of India, St. Johns Medical College, St. Johns ISID Campus 4 Institutional Area, Research Institute, Vasant Kunj, St. Johns National Academy of Health Date of approval December 10, 2012 Date of approval December 8, 2011 New Delhi-110070 Sciences, Total budget Rs 44, 25,000 Koramangala, Sarjapur Road, Total budget Rs 96, 68, 070 Bangalore-560034 Duration 24 Months Duration 36 Months Subject area HIV/AIDS/ STD Subject area Nutrition

* Approved with conditions

Indian Council of Medical Research 167 Indian Council of Medical Research 168

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

418 Treatment in early Neuritis in leprosy (TENLEP Trials)

Principal Investigator Funded by Dr. Sajid Husain Netherland Leprosy Relief Turing Foundation, The Netherlands Scientist F, National JALMA Institute for Leprosy & OMD, Taj Ganj, Date of approval March 8, 2011 Agra-282001 Total budget Rs 37, 00,000 Duration 36 Months Subject area Leprosy

419 Analysis of genetic factors influencing axial globe length and corneal curvature of the eye

Principal Investigator Funded by Dr. P Leema Reddy Neurogenetics Foundation & National Institutes of Health, USA Medical Advisor, Clinnova Research Lab, 203,204 Concord Apartments, Somajiguda, Date of approval December 8, 2011 Hyderabad-203204 Total budget Rs 17, 30, 000 Duration 42 Months Subject area Ophthalmology

420 Surgical Trial in Traumatic Intracerebral Haemohhrage (STITCH TRAUMA)

Principal Investigator Funded by Dr. P Sarat Chandra Newcastle University, United Kingdom Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2011 * Total budget Rs 23, 97, 318 Duration 36 Months Subject area Neurosciences

* Approved for inclusion of six more study sites in HMSC meeting held on September 10, 2012

169

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

418 Treatment in early Neuritis in leprosy (TENLEP Trials) 421 EU-CORE European CUBICIN outcomes registry and experience for the treatment of serious gram positive infections

Principal Investigator Funded by Principal Investigator Funded by Dr. Sajid Husain Netherland Leprosy Relief Turing Foundation, Dr. Vinod Raina Novartis Healthcare Pvt. Ltd., India The Netherlands Scientist F, Professor & Head, National JALMA Institute for Leprosy All India Institute of Medical Sciences & OMD, (AIIMS), Ansari Nagar, Taj Ganj, New Delhi-110029 Date of approval March 8, 2011 Date of approval December 8, 2011 * Agra-282001 Total budget Rs 37, 00,000 Total budget Rs 3, 00, 000 per centre Duration 36 Months Duration 6 Months Subject area Leprosy Subject area Bacteriology

419 Analysis of genetic factors influencing axial globe length and corneal curvature of the eye 422 International standardization of BCR-ABL RQ-PCR testing in patients with chronic myelogenous leukemia

Principal Investigator Funded by Principal Investigator Funded by Dr. P Leema Reddy Neurogenetics Foundation & National Institutes Dr.Renu Saxena Novartis Healthcare Pvt. Ltd., India of Health, USA Medical Advisor, Professor & Head, Clinnova Research Lab, All India Institute of Medical Sciences 203,204 Concord Apartments, (AIIMS), Ansari Nagar, Somajiguda, New Delhi-110029 Date of approval December 8, 2011 Date of approval September 10, 2012 ** Hyderabad-203204 Total budget Rs 17, 30, 000 Total budget Rs 4, 00, 000 Duration 42 Months Duration 24 Months Subject area Ophthalmology Subject area Oncology

420 Surgical Trial in Traumatic Intracerebral Haemohhrage (STITCH TRAUMA) 423 Multicenter, randomized, double blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety, and tolerability of UCL-LIV in the treatment of hyperammonemia in patients with Acute Liver Failure (ALF)

Principal Investigator Funded by Principal Investigator Funded by Dr. P Sarat Chandra Newcastle University, United Kingdom Dr. Subrat Acharya Ocera Therapeutics, Inc. CA, USA Associate Professor, Professor & Head, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval March 8, 2011 * Date of approval March 8, 2010*** Total budget Rs 23, 97, 318 Total budget Rs 39, 50,000 Duration 36 Months Duration 6 Months Subject area Neurosciences Subject area Gastroenterology

* Approved for inclusion of six more study sites in HMSC meeting held on September 10, 2012 * Approved for 4 centres only out of 11 ** Approved for other four participating Indian centers in HMSC meeting held on December 10, 2012 *** Approved for AIIMS, New Delhi and PGIMER, Chandigarh sites only

Indian Council of Medical Research 169 170

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

424 Prospective, open-label, multi-centre, phase III clinical study to investigate the efficacy and safety of human factor VWF/VIII concentrate (Wilate®) in subjects with inherited Type 3 Von Willebrand Disease (VWD) who undergo major surgical procedures

Principal Investigator Funded by Dr. Renu Saxena Octapharma, AG, Switzerland Professor and Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 10, 2012* Total budget Rs 4, 32, 000 Duration 36 Months Subject area Haematology

425 Studies on emerging and re-emerging infectious diseases, Phase II

Principal Investigator Funded by Dr. G Balakrish Nair Okayama University through Ministry of Education, Culture, Sports, Science and Scientist G & Director, Technology, Japan National Institute of Cholera and Enteric Diseases (NICED), P-33, CIT Road, Scheme XM, Date of approval March 8, 2010 Beliaghata, Kolkata-700010 Total budget Rs 2, 90, 00, 000 Duration 60 Months Subject area Diarrhoeal Diseases

426 Studies on emerging and re-emerging infectious diseases, Phase II- Subproject: “The effect of a probiotic fermented milk drink, on the intestinal microbiota and intestinal environment in both young and elderly healthy individuals in an urban community in Kolkata, India”

Principal Investigator Funded by Dr. T Ramamurthy Okayama University through Ministry of Education, Culture, Sports, Science and Scientist F, Technology, Japan National Institute of Cholera and Enteric Diseases (NICED), P-33, CIT Road, Scheme XM, Date of approval June 18, 2012 ** Beliaghata, Kolkata-700010 Total budget Not Requested Duration 6 Months Subject area Diarrhoeal Diseases

* Approved for AIIMS only ** Approved with conditions and no additional budget for this sub-project

171

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

424 Prospective, open-label, multi-centre, phase III clinical study to investigate the efficacy and safety 427 Data collection pilot study for the development of Parasight P1 device of human factor VWF/VIII concentrate (Wilate®) in subjects with inherited Type 3 Von Willebrand Disease (VWD) who undergo major surgical procedures

Principal Investigator Funded by Principal Investigator Funded by Dr. Renu Saxena Octapharma, AG, Switzerland Dr. Anupkumar Anvikar Parasight Ltd. (IL), Jerusalem Technology Park, Israel Professor and Head, Scientist D, All India Institute of Medical Sciences National Institute of Malaria Research (AIIMS), Ansari Nagar, (NIMR), Sector-8, Dwarka, New Delhi-110029 New Delhi-110077 Date of approval September 10, 2012* Date of approval June 18, 2012 Total budget Rs 4, 32, 000 Total budget Rs 3, 30, 000 Duration 36 Months Duration 6 Months Subject area Haematology Subject area Malaria

425 Studies on emerging and re-emerging infectious diseases, Phase II 428 Efficacy/evaluation of the Parasight P1 device for malaria diagnosis

Principal Investigator Funded by Principal Investigator Funded by Dr. G Balakrish Nair Okayama University through Ministry of Dr. Anupkumar Anvikar Parasight Ltd. (IL), Jerusalem Technology Park, Education, Culture, Sports, Science and Israel Scientist G & Director, Scientist D, Technology, Japan National Institute of Cholera and National Institute of Malaria Research Enteric Diseases (NICED), (NIMR), Sector-8, Dwarka, P-33, CIT Road, Scheme XM, New Delhi-110077 Date of approval March 8, 2010 Date of approval September 10, 2012 Beliaghata, Kolkata-700010 Total budget Rs 2, 90, 00, 000 Total budget Rs 13, 60, 468 Duration 60 Months Duration 12 Months Subject area Diarrhoeal Diseases Subject area Malaria

426 Studies on emerging and re-emerging infectious diseases, Phase II- Subproject: “The effect of a 429 Open-label, dose confirmation study of interstitial (131) 1-chTNT-1/BMAb (COTARA TM ) for probiotic fermented milk drink, on the intestinal microbiota and intestinal environment in both the treatment of Glioblastoma Multiforme (GBM) at first relapse young and elderly healthy individuals in an urban community in Kolkata, India”

Principal Investigator Funded by Principal Investigator Funded by Dr. T Ramamurthy Okayama University through Ministry of Dr. Deepak Gupta Peregrine Pharmaceuticals Inc., USA Education, Culture, Sports, Science and Scientist F, Assistant Professor, Technology, Japan National Institute of Cholera and All India Institute of Medical Sciences Enteric Diseases (NICED), (AIIMS), Ansari Nagar, P-33, CIT Road, Scheme XM, New Delhi-110029 Date of approval June 18, 2012 ** Date of approval March 8, 2010 Beliaghata, Kolkata-700010 Total budget Not Requested Total budget Rs 20, 00, 000 Duration 6 Months Duration 60 Months Subject area Diarrhoeal Diseases Subject area Neurosciences

* Approved for AIIMS only ** Approved with conditions and no additional budget for this sub-project

Indian Council of Medical Research 171 Indian Council of Medical Research 172

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

430 A randomized double-blind placebo-controlled phase 2 trial of bavituximab plus docetaxel in patients with previously treated locally advanced or metastatic non squamous non-small-cell lung cancer

Principal Investigator Funded by Dr. Vinod Raina Peregrine Pharmaceuticals Inc., USA Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2011 Total budget Rs 26, 38, 790 Duration 6 Months Subject area Oncology

431 International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)

Principal Investigator Funded by Dr. Anura Kurpad Pennington Biomedical Research Center, Louisiana, USA Professor & Head, St. Johns Medical College, St. Johns Research Institute, St. Johns National Academy of Health Date of approval December 10, 2012 Sciences, Koramangala, Sarjapur Road, Total budget Rs 89, 16,854 Bangalore-560034 Duration 48 Months Subject area Child Health

432 A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia

Principal Investigator Funded by Dr. Vineet Ahuja Pharmacosmos A/S Holbaek, Denmark Additional Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010* Total budget Rs 16, 00, 000 Duration 17 Months Subject area Gastroenterology

* Approved for AIIMS, New Delhi only

173

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

430 A randomized double-blind placebo-controlled phase 2 trial of bavituximab plus docetaxel in 433 INTERSTROKE-INDIA Importance of conventional and emerging risk factors for stroke in patients with previously treated locally advanced or metastatic non squamous non-small-cell lung different regions of India-A case control study cancer

Principal Investigator Funded by Principal Investigator Funded by Dr. Vinod Raina Peregrine Pharmaceuticals Inc., USA Dr. A K Roy Population Health Research Institute, McMaster University, Canada Professor & Head, Professor, All India Institute of Medical Sciences St. Johns Medical College, St. Johns (AIIMS), Ansari Nagar, Research Institute, New Delhi-110029 St. Johns National Academy of Health Date of approval December 8, 2011 Date of approval June 8, 2010 Sciences, Total budget Rs 26, 38, 790 Koramangala, Sarjapur Road, Total budget Rs 51, 55, 484 Bangalore-560034 Duration 6 Months Duration 36 Months Subject area Oncology Subject area Cardiovascular Diseases

431 International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) 434 The Peri-Operative Ischemia Evaluation (POISE-2) Trial - A large, international, placebo- controlled, factorial trial to assess the impact of clonidine and acetyl-salicylic acid (ASA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event

Principal Investigator Funded by Principal Investigator Funded by Dr. Anura Kurpad Pennington Biomedical Research Center, Dr. Alben Sigamani Population Health Research Institute, McMaster Louisiana, USA University, Canada Professor & Head, Assistant Professor, St. Johns Medical College, St. Johns St. Johns Medical College, St. Johns Research Institute, Research Institute, St. Johns National Academy of Health St. Johns National Academy of Health Date of approval December 10, 2012 Date of approval September 8, 2011* Sciences, Sciences, Koramangala, Sarjapur Road, Total budget Rs 89, 16,854 Koramangala, Sarjapur Road, Total budget Rs 6, 99, 73, 830 Bangalore-560034 Bangalore-560034 Duration 48 Months Duration 36 Months Subject area Child Health Subject area Cardiovascular Diseases

432 A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide 435 Steroids in Cardiac Surgery (SIRS) (Monofer®) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia

Principal Investigator Funded by Principal Investigator Funded by Dr. Vineet Ahuja Pharmacosmos A/S Holbaek, Denmark Prof. Narendra K Arora Population Health Research Institute, McMaster University, Canada and Hamilton Health Additional Professor, Director, Sciences Corporation, Canada All India Institute of Medical Sciences International Clinical Epidemiology (AIIMS), Ansari Nagar, Network (INCLEN), New Delhi-110029 Executive office, Date of approval December 8, 2010* Date of approval June 8, 2009** F-1/5, 2nd Floor, Total budget Rs 16, 00, 000 Okhla Industrial Area, Total budget Rs 10, 34, 000 New Delhi-110020 Duration 17 Months Duration 42 Months Subject area Gastroenterology Subject area Cardiovascular Diseases

* Approved for AIIMS, New Delhi only * Clarifications found satisfactory, approved and endorsed in HMSC meeting held on June 18, 2012 ** Approved for study sites at Fortis, Mohali & Sanjay Gandhi PG Institute of Medical Sciences, Lucknow

Indian Council of Medical Research 173 Indian Council of Medical Research 174

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

436 Single arm open-label multicenter phase II study to evaluate the efficacy and safety of P276-00 in patients with relapsed and /or refractory mantle cell lymphoma

Principal Investigator Funded by Dr. Vinod Raina Piramal Life Sciences Ltd., Mumbai Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2010 * Total budget Rs 2, 68, 000 Duration 24 Months Subject area Oncology

437 Post-licensure efficacy of a single dose of live attenuated SA 14-14-2 vaccine against Japanese Encephalitis in India

Principal Investigator Funded by Dr. Milind Gore Program for Appropriate Technology in Health (PATH), USA Scientist F, National Institute of Virology, Gorakhpur Unit, BRD Medical College Campus, Date of approval December 22, 2008 Gorakhpur-273 013 Total budget Rs 1, 68, 76, 000 Duration 12 Months Subject area Japanese Encephalitis

438 Evaluation of care HPV test in early detection of cervical cancer and precancers in the slums of Hyderabad, India- A demonstration project. (START UP project)

Principal Investigator Funded by Dr. Usha Rani Poli Program for Appropriate Technology in Health (PATH), USA Professor, Mehdi Nawaz Jung (MNJ), Institute of Oncology & RCC Red Hills, Hyderabad-500004 Date of approval March 2, 2009 Total budget Rs 51, 84, 396 Duration 36 Months Subject area Oncology

* Rectified in HMSC meeting held on March 8, 2011 for approval of study center at AIIMS only with Dr. Vinod Raina as PI in place of Dr. Reena Nair from Tata Memorial Hospital, Mumbai

175

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

436 Single arm open-label multicenter phase II study to evaluate the efficacy and safety of P276-00 in 439 Fast-HPV versus other options of screening for cancer of cervix in a rural community - A patients with relapsed and /or refractory mantle cell lymphoma demonstration project

Principal Investigator Funded by Principal Investigator Funded by Dr. Vinod Raina Piramal Life Sciences Ltd., Mumbai Dr. L Satyanarayana Program for Appropriate Technology in Health (PATH), USA Professor & Head, Scientist E, All India Institute of Medical Sciences Institute of Cytology and Preventive (AIIMS), Ansari Nagar, Oncology (ICPO), 1-7, Sector-39, New Delhi-110029 Near Degree College, Date of approval December 8, 2010 * Date of approval March 2, 2009 NOIDA-201301 Total budget Rs 2, 68, 000 Total budget Rs 58, 94, 300 Duration 24 Months Duration 30 Months Subject area Oncology Subject area Oncology

437 Post-licensure efficacy of a single dose of live attenuated SA 14-14-2 vaccine against Japanese 440 A post-licensure observational study of HPV vaccination in Khammam district Andhra Pradesh & Encephalitis in India Vadodara District, Gujarat: Demonstration

Principal Investigator Funded by Principal Investigator Funded by Dr. Milind Gore Program for Appropriate Technology in Health Dr. Martha Jacob Program for Appropriate Technology in Health (PATH), USA (PATH), USA Scientist F, Senior Program Manager, National Institute of Virology, PATH India Projects, Gorakhpur Unit, BRD Medical College A-9, Qutab Institutional Area, Campus, New Delhi-110067 Date of approval December 22, 2008 Date of approval June 8, 2009 * Gorakhpur-273 013 Total budget Rs 1, 68, 76, 000 Total budget Rs 29, 76, 000 Duration 12 Months Duration 30 Months Subject area Japanese Encephalitis Subject area Oncology

438 Evaluation of care HPV test in early detection of cervical cancer and precancers in the slums of 441 Biomarkers in transplantation external qualification phase Hyderabad, India- A demonstration project. (START UP project)

Principal Investigator Funded by Principal Investigator Funded by Dr. Usha Rani Poli Program for Appropriate Technology in Health Dr. Madhu Khullar PROOF Centre of Excellence, Vancouver, (PATH), USA Canada and Genome British Columbia, UK Professor, Professor, Mehdi Nawaz Jung (MNJ), Institute of Post Graduate Institute of Medical Oncology & RCC Red Hills, Education and Research (PGIMER), Hyderabad-500004 Sector 12-D, Date of approval March 2, 2009 Date of approval September 8, 2011 Chandigarh-160012 Total budget Rs 51, 84, 396 Total budget Rs 56, 28, 256 Duration 36 Months Duration 36 Months Subject area Oncology Subject area Genomics

* Rectified in HMSC meeting held on March 8, 2011 for approval of study center at AIIMS only with Dr. * Approved for Andhra Pradesh study site only Vinod Raina as PI in place of Dr. Reena Nair from Tata Memorial Hospital, Mumbai

Indian Council of Medical Research 175 176

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

442 Molecular epidemiology of malaria in India and Qatar with an emphasis on parasite diversity, drug resistance and immune response

Principal Investigator Funded by Dr. Neeru Singh Qatar National Research Fund National Priorities Research Program Scientist G & Director, Regional Medical Research Centre for Tribal, RMRCT Campus, Nagpur Road, Garha, Date of approval March 12, 2012 Jabalpur-482003 Total budget Rs 68, 98, 500 Duration 36 Months Subject area Malaria

443 Role of dietary glutamate on thermogenesis and sleep in rats

Principal Investigator Funded by Dr. H N Mallick Quality Assurance & External Scientific Affairs Department Ajinomoto Co; Tokyo, Japan Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 8, 2011 Total budget Rs 13, 33, 500 Duration 36 Months Subject area Nutrition

444 (Australia-Canada-India Chlamydia Research Alliance) Improved detection, treatment and control of Chlamydia infection

Principal Investigator Funded by Dr. Aruna Singh nee Mittal Queensland Government, (National and International Research Alliance Programme, Scientist F, Australia Institute of Pathology, Safdarjung Hospital Campus, Post Box 4909, Date of approval June 8, 2010 New Delhi-110029 Total budget Rs 40, 95, 600 Duration 36 Months Subject area Reproductive Health

177

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

442 Molecular epidemiology of malaria in India and Qatar with an emphasis on parasite diversity, 445 TMC International Sarcoma Kindred Study (TISKS) as a part of International Sarcoma Kindred drug resistance and immune response Study (ISKS)

Principal Investigator Funded by Principal Investigator Funded by Dr. Neeru Singh Qatar National Research Fund National Priorities Dr. Ajay Puri Rainbows for Kate Foundation, Australia Research Program Scientist G & Director, Surgeon, Regional Medical Research Centre for Tata Memorial Hospital, Tribal, RMRCT Campus, Tata Memorial Centre, Parel, Nagpur Road, Garha, Mumbai-400012 Date of approval March 12, 2012 Date of approval June 18, 2012* Jabalpur-482003 Total budget Rs 68, 98, 500 Total budget Rs 3, 70, 000 Duration 36 Months Duration 36 Months Subject area Malaria Subject area Oncology

443 Role of dietary glutamate on thermogenesis and sleep in rats 446 Serum cholesterol lowering efficacy of cookie enriched with stanol ester during regular meal

Principal Investigator Funded by Principal Investigator Funded by Dr. H N Mallick Quality Assurance & External Scientific Affairs Dr. B Sesikeran Raisio PLC, Finland Department Ajinomoto Co; Tokyo, Japan Professor, Scientist G & Director, All India Institute of Medical Sciences National Institute of Nutrition (NIN), (AIIMS), Ansari Nagar, Jamai Osmania, Tarnaka, New Delhi-110029 Hyderabad-500007 Date of approval December 8, 2011 Date of approval June 8, 2009 Total budget Rs 13, 33, 500 Total budget Rs 9, 60, 000 Duration 36 Months Duration 6 Months Subject area Nutrition Subject area Nutrition

444 (Australia-Canada-India Chlamydia Research Alliance) Improved detection, treatment and control 447 Malaria and HIV co- infection in Southern India of Chlamydia infection

Principal Investigator Funded by Principal Investigator Funded by Dr. Aruna Singh nee Mittal Queensland Government, (National and Dr. N Kumarasamy REACH Initiative of Tibotec / University of International Research Alliance Programme, California, San Diego, USA Scientist F, Chief Medical Officer, Australia Institute of Pathology, Y R Gaitonde Centre for AIDS Safdarjung Hospital Campus, Research and Education (YRG CARE), Post Box 4909, Voluntary Health Services, Taramani, Date of approval June 8, 2010 Date of approval June 8, 2009 * New Delhi-110029 Chennai-600113 Total budget Rs 40, 95, 600 Total budget Rs 15, 98, 200 Duration 36 Months Duration 12 Months Subject area Reproductive Health Subject area HIV/AIDS/ STD

* Approved with conditions

Indian Council of Medical Research 177 Indian Council of Medical Research 178

Research Projects Approved by HMSC Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

448 To study the presence of common enteric parasites found during regular hand washing 451 Burden and economic and cost of dengue in India: A retrospective study at major teaching hospitals and nearby ambulatory institutions

Principal Investigator Funded by Principal Investigator Funded by Dr. Sandipan Ganguly Research Foundation of the City University of Dr. Deoki Nandan Sanofi Pasteur, France New York (RFCUNY), USA Scientist C, Director, National Institute of Cholera and National Institute of Health and Family Enteric Diseases (NICED), Welfare, Baba Gang Nath Marg, P-33, CIT Road, Scheme XM, Munirka, Date of approval June 8, 2009 Date of approval September 8, 2011 * Beliaghata, New Delhi-110067 Kolkata-700010 Total budget Rs 4, 80, 000 Total budget Rs 36, 00, 000 Duration 12 Months Duration 12 Months Subject area Diarrhoeal Diseases Subject area Dengue

449 Exotic fish and the biological control of malaria in a biodiversity hotspot 452 Isolation and genetic characterization of circulating cell - free fetal DNA for non-invasive prenatal diagnosis of haemoglobinopathies and monitoring of pre-eclampsia (NIPPED)

Principal Investigator Funded by Principal Investigator Funded by Dr. S K Ghosh Royal Society, London, United Kingdom Dr. Madhulika Kabra Science and Innovation Ministry, Spain Scientist E, Additional Professor, National Institute of Malaria Research All India Institute of Medical Sciences (NIMR), Field Unit, Epidemic Diseases (AIIMS), Ansari Nagar, Hospital Campus, Old Madras Road, New Delhi-110029 Date of approval March 2, 2009 Date of approval September 8, 2010 * Bangalore-560038 Total budget Rs 5, 56, 000 Total budget Rs 14, 84, 000 Duration 24 Months Duration 36 Months Subject area Malaria Subject area Genomics

450 Examination of the use of traditional medicines for HIV / AIDS in India 453 Research study on the health-related quality of life of HIV/AIDS patients: Development and validation of a new specific PRO instrument

Principal Investigator Funded by Principal Investigator Funded by Dr. Jayagowri Sastry Samueli Institute for Information Biology, USA Dr. Rewa Malhotra Kohli SIDACTION, France Principal Investigator, Managing Committe Member, B J Medical College and Sassoon CARIN Trust General Hospital, National AIDS Research Institute (NARI), Jai Prakash Narayan Road, 73 G Block, MIDC, Bhosari, Date of approval December 22, 2008 * Date of approval March 8, 2010 Pune-411001 Post Box No. 1875, Total budget Rs 24, 49, 125 Pune-411026 Total budget Rs 1, 22, 018 Duration 24 Months Duration 3 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Approved with conditions * Approved with conditions

179 Indian Council of Medical Research 180

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

448 To study the presence of common enteric parasites found during regular hand washing 451 Burden and economic and cost of dengue in India: A retrospective study at major teaching hospitals and nearby ambulatory institutions

Principal Investigator Funded by Principal Investigator Funded by Dr. Sandipan Ganguly Research Foundation of the City University of Dr. Deoki Nandan Sanofi Pasteur, France New York (RFCUNY), USA Scientist C, Director, National Institute of Cholera and National Institute of Health and Family Enteric Diseases (NICED), Welfare, Baba Gang Nath Marg, P-33, CIT Road, Scheme XM, Munirka, Date of approval June 8, 2009 Date of approval September 8, 2011 * Beliaghata, New Delhi-110067 Kolkata-700010 Total budget Rs 4, 80, 000 Total budget Rs 36, 00, 000 Duration 12 Months Duration 12 Months Subject area Diarrhoeal Diseases Subject area Dengue

449 Exotic fish and the biological control of malaria in a biodiversity hotspot 452 Isolation and genetic characterization of circulating cell - free fetal DNA for non-invasive prenatal diagnosis of haemoglobinopathies and monitoring of pre-eclampsia (NIPPED)

Principal Investigator Funded by Principal Investigator Funded by Dr. S K Ghosh Royal Society, London, United Kingdom Dr. Madhulika Kabra Science and Innovation Ministry, Spain Scientist E, Additional Professor, National Institute of Malaria Research All India Institute of Medical Sciences (NIMR), Field Unit, Epidemic Diseases (AIIMS), Ansari Nagar, Hospital Campus, Old Madras Road, New Delhi-110029 Date of approval March 2, 2009 Date of approval September 8, 2010 * Bangalore-560038 Total budget Rs 5, 56, 000 Total budget Rs 14, 84, 000 Duration 24 Months Duration 36 Months Subject area Malaria Subject area Genomics

450 Examination of the use of traditional medicines for HIV / AIDS in India 453 Research study on the health-related quality of life of HIV/AIDS patients: Development and validation of a new specific PRO instrument

Principal Investigator Funded by Principal Investigator Funded by Dr. Jayagowri Sastry Samueli Institute for Information Biology, USA Dr. Rewa Malhotra Kohli SIDACTION, France Principal Investigator, Managing Committe Member, B J Medical College and Sassoon CARIN Trust General Hospital, National AIDS Research Institute (NARI), Jai Prakash Narayan Road, 73 G Block, MIDC, Bhosari, Date of approval December 22, 2008 * Date of approval March 8, 2010 Pune-411001 Post Box No. 1875, Total budget Rs 24, 49, 125 Pune-411026 Total budget Rs 1, 22, 018 Duration 24 Months Duration 3 Months Subject area HIV/AIDS/ STD Subject area HIV/AIDS/ STD

* Approved with conditions * Approved with conditions

Indian Council of Medical Research 179 180

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

454 Delhi eye banking pilot study - Dr. R.P. Centre for Ophthalmic Sciences / AIIMS Dr. Shroff Charity Eye Hospital, and Sightlife

Principal Investigator Funded by Dr. Azad Rajvardhan Sight Life, Seattle, USA Professor & Chief, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012 Total budget Rs 8, 39, 000 Duration 12 Months Subject area Ophthalmology

455 Aspirin for Dukes C and high risk Dukes B colorectal Cancers, An international, multicentre, double blind, randomized placebo controlled phase III trial

Principal Investigator Funded by Dr. Atul Sharma Singapore Clinical Research Institute, Singapore Associate Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 10, 2012 Total budget Rs 2, 47, 50, 000 Duration 60 Months Subject area Oncology

456 Evaluation of ventricular intrinsic preference plus ventricular auto capture features in dual chamber pacemaker patients

Principal Investigator Funded by Dr. Rakesh Yadav St. Jude Medical HongKong Pvt Ltd. Additional Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2011* Total budget Rs 3, 81, 800 Duration 36 Months Subject area Cardiovascular Diseases

* Approved for AIIMS only

181

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

454 Delhi eye banking pilot study - Dr. R.P. Centre for Ophthalmic Sciences / AIIMS Dr. Shroff 457 Efficacy of the preseNce of right ventricular apical pacing induced ventricular dyssyncHrony as a Charity Eye Hospital, and Sightlife guiding pArameter for biveNtricular pacing in patients with bradycardia and normal ejection fraction (ENHANCE)

Principal Investigator Funded by Principal Investigator Funded by Dr. Azad Rajvardhan Sight Life, Seattle, USA Dr. Rakesh Yadav St. Jude Medical India Pvt. Ltd. Professor & Chief, Additional Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval March 12, 2012 Date of approval September 10, 2012* Total budget Rs 8, 39, 000 Total budget Rs 7, 57, 710 Duration 12 Months Duration 36 Months Subject area Ophthalmology Subject area Cardiovascular Diseases

455 Aspirin for Dukes C and high risk Dukes B colorectal Cancers, An international, multicentre, 458 More options available with quadripolar LV lead pRovidE in clinical solution to CRT challenges double blind, randomized placebo controlled phase III trial (More CRT)

Principal Investigator Funded by Principal Investigator Funded by Dr. Atul Sharma Singapore Clinical Research Institute, Singapore Dr. Gautam Sharma St. Jude Medical India Pvt. Ltd. Associate Professor, Additional Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval September 10, 2012 Date of approval September 10, 2012* Total budget Rs 2, 47, 50, 000 Total budget Rs 7, 52, 001 Duration 60 Months Duration 30 Months Subject area Oncology Subject area Cardiovascular Diseases

456 Evaluation of ventricular intrinsic preference plus ventricular auto capture features in dual 459 Valacyclovir augmentation for cognitive and functional remediation in schizophrenia: Replication chamber pacemaker patients and extension

Principal Investigator Funded by Principal Investigator Funded by Dr. Rakesh Yadav St. Jude Medical HongKong Pvt Ltd. Dr. Smita N Deshpande Stanley Medical Research Institute, USA Additional Professor, Head of Department, All India Institute of Medical Sciences Dr. Ram Manohar Lohia Hospital, (AIIMS), Ansari Nagar, Baba Kharag Singh Marg, New Delhi-110029 New Delhi-110001 Date of approval March 8, 2011* Date of approval September 10, 2012 ** Total budget Rs 3, 81, 800 Total budget Rs 7, 28, 73, 320 Duration 36 Months Duration 36 Months Subject area Cardiovascular Diseases Subject area Mental Health

* Approved for AIIMS only * Approved for AIIMS, New Delhi only ** Approved with conditions

Indian Council of Medical Research 181 Indian Council of Medical Research 182

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

460 Expanding the medical abortion provider base in India: Building evidence on the feasibility of provision of abortion by ayurvedic and homeopathic doctors and nurses

Principal Investigator Funded by Dr. Shireen Jejeebhoy Swedish International Development Cooperation Agency (SIDA), Sweden Senior Associate, Population Council South & East Asia- Regional Office, Zone 5 A, Ground Floor, Date of approval March 2, 2009 India Habitat Centre, Lodi Road, New Delhi-110003 Total budget Rs 79, 09, 100 Duration 18 Months Subject area Reproductive Health

461 Management of medical abortion in India provided by midlevel providers or physicians: A two arm randomized controlled trial

Principal Investigator Funded by Dr. Suneeta Mittal Swedish International Development Cooperation Agency (SIDA), Sweden Professor & Unit Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012 Total budget Rs 26, 49, 865 Duration 24 Months Subject area Reproductive Health

462 Expanding the provider base in India: The feasibility of MVA provision by non-MBBS providers

Principal Investigator Funded by Dr. Shireen Jejeebhoy The David and Lucile Packard Foundation, USA Senior Associate, Population Council South & East Asia- Regional Office, Zone 5 A, Ground Floor, Date of approval March 8, 2010 India Habitat Centre, Lodi Road, New Delhi-110003 Total budget Rs 2, 64, 00, 052 Duration 18 Months Subject area Reproductive Health

183

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

460 Expanding the medical abortion provider base in India: Building evidence on the feasibility of 463 Impact of climate variability and urbanization on water storage practices and vector-borne disease provision of abortion by ayurvedic and homeopathic doctors and nurses incidence: Developing an understanding for risk prediction and response using Delhi, India as context

Principal Investigator Funded by Principal Investigator Funded by Dr. Shireen Jejeebhoy Swedish International Development Cooperation Dr. R C Dhiman The Earth Institute, Columbia University, USA Agency (SIDA), Sweden Senior Associate, Scientist F, Population Council South & East Asia- National Institute of Malaria Research Regional Office, (NIMR), Sector 8, Dwarka, Zone 5 A, Ground Floor, New Delhi-110077 Date of approval March 2, 2009 Date of approval March 12, 2012 India Habitat Centre, Lodi Road, New Delhi-110003 Total budget Rs 79, 09, 100 Total budget Rs 1, 30, 688 Duration 18 Months Duration 6 Months Subject area Reproductive Health Subject area Vector Borne Diseases

461 Management of medical abortion in India provided by midlevel providers or physicians: A two 464 Functional analysis of oral cancer-specific tumour suppressor p53 mutants: Differential gene arm randomized controlled trial expression profiling and its relation to p53-DBS binding in epithelial cells expressing various oral cancer-specific p53 mutants

Principal Investigator Funded by Principal Investigator Funded by Dr. Suneeta Mittal Swedish International Development Cooperation Dr. Uttam Pati The International Agency for Research on Cancer Agency (SIDA), Sweden (IARC), France Professor & Unit Head, Professor, All India Institute of Medical Sciences School of Biotechnology, (AIIMS), Ansari Nagar, Jawaharlal Nehru University, New Delhi-110029 New Mehrauli Road, Date of approval March 12, 2012 Date of approval March 25, 2008 New Delhi-110067 Total budget Rs 26, 49, 865 Total budget Rs 1, 53, 64, 000 Duration 24 Months Duration 48 Months Subject area Reproductive Health Subject area Oncology

462 Expanding the provider base in India: The feasibility of MVA provision by non-MBBS providers 465 Study on association of Human Papilloma Virus in carcinoma esophagus in females

Principal Investigator Funded by Principal Investigator Funded by Dr. Shireen Jejeebhoy The David and Lucile Packard Foundation, USA Dr. D P Punia The International Agency for Research on Cancer (IARC), France Senior Associate, Director, Population Council South & East Asia- Acharya Tulsi Regional Cancer Regional Office, Treatment & Research Institute, Zone 5 A, Ground Floor, Bikaner-334001 Date of approval March 8, 2010 Date of approval March 25, 2008 India Habitat Centre, Lodi Road, New Delhi-110003 Total budget Rs 2, 64, 00, 052 Total budget Rs 35, 50,000 Duration 18 Months Duration 36 Months Subject area Reproductive Health Subject area Oncology

Indian Council of Medical Research 183 184

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

466 Pattern of survival and quality of life of oesophagus, stomach, nasapharynx, hepatocellular, lung cancer patients in North East Region of India

Principal Investigator Funded by Dr. J Mahanta The International Agency for Research on Cancer (IARC), France Scientist G & Director, Regional Medical Research Centre (RMRC), NE Region, Post Box No. 105, Date of approval June 23, 2008 Dibrugarh-786001 Total budget Rs 1, 50, 43, 248 Duration 48 Months Subject area Oncology

467 Effectiveness and safety of 2 vs. 3 doses of HPV vaccine in preventing cervical cancer: An Indian multi-centre randomized trial

Principal Investigator Funded by Dr. Neeraj Bhatla The International Agency for Research on Cancer (IARC), France Additional Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval December 22, 2008* Total budget Rs 92, 00, 000 Duration 60 Months Subject area Oncology

468 Expanding research capacity in rural Maharashtra: NARI-AIDS Rural Research Initiative in Maharashtra (N-ARRIM)

Principal Investigator Funded by Dr. Seema Sahay The International AIDS Vaccine Institute, New Delhi Scientist D, National AIDS Research Institute (NARI), 73 G Block, MIDC, Bhosari, Post Box No. 1875, Date of approval December 8, 2011 Pune-411026 Total budget Rs 64, 94, 540 Duration 24 Months Subject area HIV/AIDS/ STD

* Approved with suggestion that result of the study should be reviewed after 3 years of intiation of study

185

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

466 Pattern of survival and quality of life of oesophagus, stomach, nasapharynx, hepatocellular, lung 469 The evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with cancer patients in North East Region of India MDR - TB (STREAM)

Principal Investigator Funded by Principal Investigator Funded by Dr. J Mahanta The International Agency for Research on Cancer Dr. Aleyamma Thomas The International Union Against Tuberculosis & (IARC), France Lung Diseases, USA Scientist G & Director, Scientist F, Regional Medical Research Centre National Institute for Research in (RMRC), NE Region, Tuberculosis (NIRT), Post Box No. 105, Mayor V.R. Ramanathan Road, Date of approval June 23, 2008 Date of approval June 18, 2012 * Dibrugarh-786001 Chetput, Total budget Rs 1, 50, 43, 248 Chennai-600031 Total budget Rs 4, 67, 62,515 Duration 48 Months Duration 48 Months Subject area Oncology Subject area Tuberculosis

467 Effectiveness and safety of 2 vs. 3 doses of HPV vaccine in preventing cervical cancer: An Indian 470 Safety and immunogenicity of a killed oral cholera vaccine among infants aged 10 weeks to 6 multi-centre randomized trial months when given concomitantly with EPI vaccines

Principal Investigator Funded by Principal Investigator Funded by Dr. Neeraj Bhatla The International Agency for Research on Cancer Dr. Alok Kumar Deb The International Vaccine Institute, Korea (IARC), France Additional Professor, Scientist C, All India Institute of Medical Sciences National Institute of Cholera and (AIIMS), Ansari Nagar, Enteric Diseases (NICED), New Delhi-110029 * P-33, CIT Road, Scheme XM, Date of approval December 22, 2008 Date of approval March 25, 2008 Beliaghata, Total budget Rs 92, 00, 000 Kolkata-700010 Total budget Rs 31, 96, 089 Duration 60 Months Duration 15 Months Subject area Oncology Subject area Diarrhoeal Diseases

468 Expanding research capacity in rural Maharashtra: NARI-AIDS Rural Research Initiative in 471 Exploration of the biologic basis for underperformance of oral polio and rotavirus vaccine in India Maharashtra (N-ARRIM)

Principal Investigator Funded by Principal Investigator Funded by Dr. Seema Sahay The International AIDS Vaccine Institute, New Dr. Dipika Sur The International Vaccine Institute, Korea Delhi Scientist D, Scientist F, National AIDS Research Institute (NARI), National Institute of Cholera and 73 G Block, MIDC, Bhosari, Enteric Diseases (NICED), Post Box No. 1875, P-33, CIT Road, Scheme XM, Date of approval December 8, 2011 Date of approval December 8, 2011 Pune-411026 Beliaghata, Total budget Rs 64, 94, 540 Kolkata-700010 Total budget Rs 1, 24, 00, 000 Duration 24 Months Duration 36 Months Subject area HIV/AIDS/ STD Subject area Other Infectious Diseases

* Approved with suggestion that result of the study should be reviewed after 3 years of intiation of study * Approved with conditions

Indian Council of Medical Research 185 186

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

472 Effectiveness of a bivalent, killed whole cell based oral cholera vaccine introduced in Satyabadi, Orissa

Principal Investigator Funded by Dr. Shantanu K Kar The International Vaccine Institute, Korea Scientist G & Director, Regional Medical Research Centre (RMRC), Chandrasekharpur, Bhubaneswar-751023 Date of approval March 12, 2012 Total budget Rs 51, 52, 848 Duration 12 Months Subject area Diarrhoeal Diseases

473 Etiology of community acquired pneumonia in children: A prospective, community and hospital- based study

Principal Investigator Funded by Prof. Sunit Singhi The Pediatric Research Foundation at Astrid Lindgren Children's Hospital, Sweden Head, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval September 8, 2010 * Chandigarh-160012 Total budget Rs 2, 31, 80, 000 Duration 24 Months Subject area Child Health

474 CNS infection in Indian children: Predisposing factors and biochemical markers for diagnosis and prognosis (improving diagnosis and prevention)

Principal Investigator Funded by Prof. Sunit Singhi The Pediatric Research Foundation at Astrid Lindgren Children's Hospital, Sweden Head, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval December 10, 2012 Chandigarh-160012 Total budget Rs 1, 58, 19, 667 Duration 36 Months Subject area Child Health

* Approved with conditions

187

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

472 Effectiveness of a bivalent, killed whole cell based oral cholera vaccine introduced in Satyabadi, 475 A Phase II, placebo-controlled, double-blind, randomized trial to evaluate the anti-bacterial Orissa activity, safety, and tolerability of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB)

Principal Investigator Funded by Principal Investigator Funded by Dr. Shantanu K Kar The International Vaccine Institute, Korea Dr. Aleyamma Thomas Tibotec, BVBA (a subsidiary of Johnson and Johnson Ltd), Belgium Scientist G & Director, Scientist F, Regional Medical Research Centre National Institute for Research in (RMRC), Chandrasekharpur, Tuberculosis (NIRT), Bhubaneswar-751023 Mayor V.R. Ramanathan Road, Date of approval March 12, 2012 Date of approval June 8, 2009 * Chetput, Total budget Rs 51, 52, 848 Chennai-600031 Total budget Rs 14, 06, 000 Duration 12 Months Duration 36 Months Subject area Diarrhoeal Diseases Subject area Tuberculosis

473 Etiology of community acquired pneumonia in children: A prospective, community and hospital- 476 A phase II, open-label trial with TMC207 as part of a multi-drug resistant tuberculosis (MDR-TB) based study treatment regimen in subjects with sputum smear-positive pulmonary infection with MDR-TB

Principal Investigator Funded by Principal Investigator Funded by Prof. Sunit Singhi The Pediatric Research Foundation at Astrid Dr. S K Sharma Tibotec, BVBA (a subsidiary of Johnson and Lindgren Children's Hospital, Sweden Johnson Ltd), Belgium Head, Professor & Head, Post Graduate Institute of Medical All India Institute of Medical Sciences Education and Research (PGIMER), (AIIMS), Ansari Nagar, Sector 12-D, New Delhi-110029 Date of approval September 8, 2010 * Date of approval December 8, 2010 * Chandigarh-160012 Total budget Rs 2, 31, 80, 000 Total budget Rs 99, 99, 250 Duration 24 Months Duration 36 Months Subject area Child Health Subject area Tuberculosis

474 CNS infection in Indian children: Predisposing factors and biochemical markers for diagnosis and 477 The mercury and infant neurological development study in India-pilot phase prognosis (improving diagnosis and prevention)

Principal Investigator Funded by Principal Investigator Funded by Prof. Sunit Singhi The Pediatric Research Foundation at Astrid Dr. Satish Rao UAB Sparkman Centre for Global Health, USA Lindgren Children's Hospital, Sweden Head, Professor, Post Graduate Institute of Medical Manipal Life Sciences, Manipal Education and Research (PGIMER), University, Madhav Nagar, Sector 12-D, Manipal-576104 Date of approval December 10, 2012 Date of approval December 22, 2008 Chandigarh-160012 Total budget Rs 1, 58, 19, 667 Total budget Rs 4, 22, 520 Duration 36 Months Duration 12 Months Subject area Child Health Subject area Neurosciences

* Approved with conditions * Approved with conditions

Indian Council of Medical Research 187 188

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

478 Replacement of insecticides to control visceral leishmaniasis

Principal Investigator Funded by Dr. Pradeep Das UBS, Switzerland / TDR Scientist G & Director, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Agamkuan, Date of approval March 12, 2012 Patna-800007 Total budget Rs 13, 44, 000 Duration 14 Months Subject area Leishmaniasis

479 Genetic basis of stroke in an Indian population

Principal Investigator Funded by Dr. Kameshwar Prasad UK-India Education and Research Initiative (UKIERI), United Kingdom Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 8, 2009 Total budget Rs 36, 55, 264 Duration 36 Months Subject area Neurosciences

480 Untreated heart failure: Activation of the immunological and inflammatory systems and changes after short-term treatment

Principal Investigator Funded by Dr. Balram Bhargava UK-India Education and Research Initiative (UKIERI), United Kingdom Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 2, 2009 Total budget Rs 14, 27, 674 Duration 36 Months Subject area Cardiovascular Diseases

189

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

478 Replacement of insecticides to control visceral leishmaniasis 481 Study of fibrosis in heart failure

Principal Investigator Funded by Principal Investigator Funded by Dr. Pradeep Das UBS, Switzerland / TDR Prof. S K Maulik UK-India Education and Research Initiative (UKIERI), United Kingdom Scientist G & Director, Professor, Rajendra Memorial Research Institute All India Institute of Medical Sciences of Medical Sciences (RMRIMS), (AIIMS), Ansari Nagar, Agamkuan, New Delhi-110029 Date of approval March 12, 2012 Date of approval September 10, 2012 Patna-800007 Total budget Rs 13, 44, 000 Total budget Rs 17, 00, 000 Duration 14 Months Duration 24 Months Subject area Leishmaniasis Subject area Cardiovascular Diseases

479 Genetic basis of stroke in an Indian population 482 Development of neonatal health care service delivery model for rural India

Principal Investigator Funded by Principal Investigator Funded by Dr. Kameshwar Prasad UK-India Education and Research Initiative Dr. Anand Krishnan United Nations International Children's (UKIERI), United Kingdom Emergency Fund (UNICEF), New Delhi, India Professor, Additional Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval September 8, 2009 New Delhi- 110029 Date of approval June 8, 2011 * Total budget Rs 36, 55, 264 Total budget Rs 85, 69, 722 Duration 36 Months Duration 36 Months Subject area Neurosciences Subject area Child Health

480 Untreated heart failure: Activation of the immunological and inflammatory systems and changes 483 Methadone maintenance treatment in India: A feasibility and effectiveness study after short-term treatment

Principal Investigator Funded by Principal Investigator Funded by Dr. Balram Bhargava UK-India Education and Research Initiative Dr. Anju Dhawan United Nations Office on Durgs and Crime, (UKIERI), United Kingdom Regional Office for South Asia (UNODC ROSA) Professor, Associate Professor, All India Institute of Medical Sciences All India Institute of Medical Sciences (AIIMS), Ansari Nagar, (AIIMS), Ansari Nagar, New Delhi-110029 New Delhi-110029 Date of approval March 2, 2009 Date of approval March 8, 2011 ** Total budget Rs 14, 27, 674 Total budget Rs 20, 94, 402 Duration 36 Months Duration 18 Months Subject area Cardiovascular Diseases Subject area Mental Health

* Approved with suggestion ** Approved with condition

Indian Council of Medical Research 189 190

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

484 Hib meningitis sentinel surveillance in Uttar Pradesh

Principal Investigator Funded by Dr. Vishwajeet Kumar United States Agency for International Development (USAID), India Office Project Director, Chhatrapati Shahuji Maharaja Medical University, (Erstwhile King George Medical College), Date of approval March 2, 2009 Chowk, Lucknow-226003 Total budget Rs 94, 85, 804 Duration 13 Months Subject area Bacteriology

485 Hib meningitis sentinel surveillance in North India

Principal Investigator Funded by Dr. Shinjini Bhatnagar United States Agency for International Development (USAID), India Office Pediatric Gastroenterologist, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 2, 2009 Total budget Rs 64, 35, 464 Duration 13 Months Subject area Bacteriology

486 Survey of women and private providers to determine perspectives on using the private sector for family planning: Phase 1: Survey of Women

Principal Investigator Funded by Dr. Ashish Gupta United States Agency for International Development (USAID), USA Technical Officer, Family Health International (FHI), India Country Office, 16, Sunder Nagar, Date of approval June 8, 2009 New Delhi-110003 Total budget Rs 28, 70, 000 Duration 2-3 Months Subject area Reproductive Health

191

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

484 Hib meningitis sentinel surveillance in Uttar Pradesh 487 Investigate the pathways and nutritional modulation of methyl group production in under weight and normal weight pregnant women

Principal Investigator Funded by Principal Investigator Funded by Dr. Vishwajeet Kumar United States Agency for International Dr. Anura Kurpad United States Department of Agriculture, USA Development (USAID), India Office Project Director, Dean, Chhatrapati Shahuji Maharaja Medical St. Johns Medical College, St. Johns University, (Erstwhile King George Research Institute, Medical College), St. Johns National Academy of Health Date of approval March 2, 2009 Date of approval June 8, 2010 * Chowk, Sciences, Lucknow-226003 Total budget Rs 94, 85, 804 Koramangala, Sarjapur Road, Total budget Rs 1, 15, 00, 000 Bangalore-560034 Duration 13 Months Duration 60 Months Subject area Bacteriology Subject area Nutrition

485 Hib meningitis sentinel surveillance in North India 488 The CLIP (Community Level Interventions for Pre-eclampsia) cluster randomized controlled trial

Principal Investigator Funded by Principal Investigator Funded by Dr. Shinjini Bhatnagar United States Agency for International Dr. M B Bellad University of British Columbia, Canada Development (USAID), India Office Pediatric Gastroenterologist, Professor All India Institute of Medical Sciences Jawaharlal Nehru Medical College, (AIIMS), Ansari Nagar, JNMC Campus, Nehru Nagar, New Delhi-110029 Belgaum-590010 Date of approval March 2, 2009 Date of approval September 10, 2012 * Total budget Rs 64, 35, 464 Total budget Rs 7, 11, 00, 267 Duration 13 Months Duration 72 Months Subject area Bacteriology Subject area Reproductive Health

486 Survey of women and private providers to determine perspectives on using the private sector for 489 Coronary heart disease in Goa: Prevalence and risk in general practice family planning: Phase 1: Survey of Women

Principal Investigator Funded by Principal Investigator Funded by Dr. Ashish Gupta United States Agency for International Dr. Gladstone D'Costa University College London, United Kingdom Development (USAID), USA Technical Officer, Vice President, Family Health International (FHI), Voluntary Health Association of Goa, India Country Office, 12, Ranghavi Estate Bogmalo Road, 16, Sunder Nagar, Dabolim, Date of approval June 8, 2009 Date of approval June 23, 2008 New Delhi-110003 Goa-403801 Total budget Rs 28, 70, 000 Total budget Rs 7, 56, 000 Duration 2-3 Months Duration 6 Months Subject area Reproductive Health Subject area Cardiovascular Diseases

* Approved with conditions

Indian Council of Medical Research 191 192

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

490 Predicting hematoma growth and outcome in intracerebral hemorrhage using contrast bolus CT (PREDICT) study

Principal Investigator Funded by Dr. M V Padma University of Calgary, Canada Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 25, 2008* Total budget Rs 1, 56, 000 Duration 12 Months Subject area Neurosciences

491 To explore the role of dendritic cells in immune modulation and prognosis of colon cancer patients

Principal Investigator Funded by Dr. S V Rana University of California, San Diego, USA Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval ** Chandigarh-160012 March 8, 2010 Total budget Rs 25, 00, 000 Duration 36 Months Subject area Oncology

492 Study of bovine leukemia virus infection to breast cancer in Indian women

Principal Investigator Funded by Dr. Nitin Gangane University of California, Berkeley, USA

Professor& Head, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha-442102 Date of approval March 25, 2008 Total budget Not Requested Duration 6 Months Subject area Oncology

* Approved with conditions ** Approved for technical collaboration only

193

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

490 Predicting hematoma growth and outcome in intracerebral hemorrhage using contrast bolus CT 493 India newborn stove project pilot study in Palwal (Haryana) (PREDICT) study

Principal Investigator Funded by Principal Investigator Funded by Dr. M V Padma University of Calgary, Canada Prof. Narendra K Arora University of California, Berkeley, USA Professor, Executive Director, All India Institute of Medical Sciences The INCLEN Trust International & CHNRI, (AIIMS), Ansari Nagar, F-1/5, 2nd Floor, Okhla Industrial Area, New Delhi-110029 * Date of approval September 8, 2011 Date of approval March 25, 2008 New Delhi-110020 Total budget Rs 1, 56, 000 Total budget Rs 26, 06, 544 Duration 12 Months Duration 12 Months Subject area Neurosciences Subject area Environmental Health

491 To explore the role of dendritic cells in immune modulation and prognosis of colon cancer 494 European Society of intensive care medicine study of therapeutic hypothermia (32-35˚C) for ICP patients reduction after traumatic brain injury. Eurotherm3235 trial

Principal Investigator Funded by Principal Investigator Funded by Dr. S V Rana University of California, San Diego, USA Dr. Deepak Gupta University of Edinburgh, United Kingdom Professor, Associate Professor, Post Graduate Institute of Medical All India Institute of Medical Sciences Education and Research (PGIMER), (AIIMS), Ansari Nagar, Sector 12-D, New Delhi-110029 Date of approval ** Date of approval December 10, 2012 Chandigarh-160012 March 8, 2010 Total budget Rs 25, 00, 000 Total budget Rs 35, 67, 256 Duration 36 Months Duration 36 Months Subject area Oncology Subject area Neurosciences

492 Study of bovine leukemia virus infection to breast cancer in Indian women 495 Developing a framework for predicting malaria outbreaks in rural and urban areas of Gujarat and Rajasthan in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Nitin Gangane University of California, Berkeley, USA Dr. R C Dhiman University of Michigan, USA Scientist F, Professor& Head, National Institute of Malaria Research Mahatma Gandhi Institute of Medical (NIMR), Sector-8, Dwarka, Sciences, Sevagram, New Delhi-110077 * Wardha-442102 Date of approval March 25, 2008 Date of approval March 2, 2009 Total budget Not Requested Total budget Rs 99, 11, 100 Duration 6 Months Duration 36 Months Subject area Oncology Subject area Malaria

* Approved with conditions * The extension approved in HMSC meeting held on March 12, 2012 without additional funds ** Approved for technical collaboration only

Indian Council of Medical Research 193 Indian Council of Medical Research 194

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

496 Role of Toll-Like Receptors (TLRs) and cytokines in the immune response due to Scrub Typhus

Principal Investigator Funded by Dr. George Varghese University of Oslo, Norway Associate Professor, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval September 8, 2010 Total budget Rs 14, 65, 000 Duration 24 Months Subject area Immunology

497 Immuno-Pathogenic mechanisms in acute Febrile illness (IPF) proposal 1 - acute malaria

Principal Investigator Funded by Dr. Dilip Mathai University of Oslo, Norway Head, Christian Medical College & Hospital, Ida Scudder Road, Vellore-632004 Date of approval December 8, 2011 Total budget Rs 4, 27, 50, 000 Duration 24 Months Subject area Malaria

498 The International fetal and newborn growth standards for the 21st Century "INTERGROWTH- 21st"

Principal Investigator Funded by Dr. Manorama Purwar University of Oxford, United Kingdom Ex. Professor, Neelgagan Housing Society, B/302, Balraj Marg, Dhantoli, Nagpur-440012 Date of approval March 2, 2009 Total budget Rs 1, 59, 93, 045 Duration 36 Months Subject area Child Health

195

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

496 Role of Toll-Like Receptors (TLRs) and cytokines in the immune response due to Scrub Typhus 499 A study of lifelong vegetarianism and other risk factors and the risk of breast cancer in the Indian population

Principal Investigator Funded by Principal Investigator Funded by Dr. George Varghese University of Oslo, Norway Dr. Vinod Raina University of Oxford, United Kingdom Associate Professor, Professor & Head, Christian Medical College & Hospital, All India Institute of Medical Sciences Ida Scudder Road, (AIIMS), Ansari Nagar, Vellore-632004 New Delhi-110029 Date of approval September 8, 2010 Date of approval June 18, 2012 Total budget Rs 14, 65, 000 Total budget Rs 2, 80, 000 per annum Duration 24 Months Duration 36 Months Subject area Immunology Subject area Oncology

497 Immuno-Pathogenic mechanisms in acute Febrile illness (IPF) proposal 1 - acute malaria 500 The international fetal and newborn growth standards for the 21st century “INTERGROWTH-21” Added component: Post Natal Infant Follow up Study (PIFS) component

Principal Investigator Funded by Principal Investigator Funded by Dr. Dilip Mathai University of Oslo, Norway Dr. Manorama Purwar University of Oxford, United Kingdom Head, Ex. Professor, Christian Medical College & Hospital, Neelgagan Housing Society, Ida Scudder Road, B/302, Balraj Marg, Dhantoli, Vellore-632004 Nagpur-440012 Date of approval December 8, 2011 Date of approval December 10, 2012 Total budget Rs 4, 27, 50, 000 Total budget Rs. 98, 18, 000 Duration 24 Months Duration 24 Months Subject area Malaria Subject area Child Health

498 The International fetal and newborn growth standards for the 21st Century "INTERGROWTH- 501 Mobility and Independent Living in Elders Study (MILES) 21st"

Principal Investigator Funded by Principal Investigator Funded by Dr. Manorama Purwar University of Oxford, United Kingdom Dr. K Govind Narsingrao University of Pittsburgh, USA Ex. Professor, Associate Professor, Neelgagan Housing Society, SHARE India, MediCiti Institute of B/302, Balraj Marg, Dhantoli, Medical Sciences (MIMS), Nagpur-440012 Ghanpur Village, Medchal Mandal, Date of approval March 2, 2009 Date of approval March 8, 2011* R.R.District-501401, Andhra Pradesh Total budget Rs 1, 59, 93, 045 Total budget Rs 1, 10, 12, 248 Duration 36 Months Duration 60 Months Subject area Child Health Subject area Life Style Diseases

* Approved with conditions

Indian Council of Medical Research 195 196

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

502 Intestinal Parasitic and Vaginal Infections in pregnancy outcomes (IPVI) study

Principal Investigator Funded by Dr. Kalpana Betha University of Pittsburgh, USA Associate Professor, SHARE INDIA - Mediciti Institute of Medical Science (MIMS), Ghanpur Village, Medchal Mandal, Date of approval June 18, 2012 R .R. District-501401, Andhra Pradesh Total budget Rs 2, 92, 07, 242 Duration 60 Months Subject area Reproductive Health

503 Mycolic acid antibody real time inhibition in the serodianosis of tuberculosis

Principal Investigator Funded by Dr. D Behera University of Pretoria, South Africa (Funded by DST, Government of India) Director, LRS Institute of TB & Respiratory Diseases, Sri Aurobindo Marg, Near Qutub Minar, Date of approval June 8, 2011 New Delhi-110030 Total budget Rs 46, 03, 000 Duration 36 Months Subject area Tuberculosis

504 To study the inflammatory aspect of HIV - 1 clade C tat in vivo

Principal Investigator Funded by Dr. Sarman Singh University of Rochester, DCFAR, USA Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 12, 2012 Total budget Rs 9, 00, 000 Duration 12 Months Subject area HIV/AIDS/ STD

Indian Council of Medical Research 197

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

502 Intestinal Parasitic and Vaginal Infections in pregnancy outcomes (IPVI) study 505 Exploring health attitudes and perception on diet and physical activity among school children in Delhi, India

Principal Investigator Funded by Principal Investigator Funded by Dr. Kalpana Betha University of Pittsburgh, USA Dr. Monika Arora University of Southern California (USC), USA Associate Professor, Senior Director, SHARE INDIA - Mediciti Institute of Health Related Information Dissemination, Medical Science (MIMS), Amongst Youth (HRIDAY), Ghanpur Village, Medchal Mandal, Safdarjung Development Area, Date of approval June 18, 2012 Date of approval March 8, 2011 R .R. District-501401, Andhra Pradesh New Delhi-110016 Total budget Rs 2, 92, 07, 242 Total budget Rs 2, 95, 400 Duration 60 Months Duration 6 Months Subject area Reproductive Health Subject area Child Health

503 Mycolic acid antibody real time inhibition in the serodianosis of tuberculosis 506 A multicenter, double-blind, randomized study to compare the safety and efficacy of prulifloxacin versus placebo in the treatment of acute gastroenteritis in adult travellers

Principal Investigator Funded by Principal Investigator Funded by Dr. D Behera University of Pretoria, South Africa (Funded by Dr. Ranjan K Nandy University of Texas, USA DST, Government of India) Director, Scientist C, LRS Institute of TB & Respiratory National Institute of Cholera and Diseases, Sri Aurobindo Marg, Enteric Diseases (NICED), Near Qutub Minar, P-33, CIT Road, Scheme XM, Date of approval June 8, 2011 Date of approval March 2, 2009 New Delhi-110030 Beliaghata, Total budget Rs 46, 03, 000 Kolkata-700010 Total budget Rs 13, 60, 000 Duration 36 Months Duration 12 Months Subject area Tuberculosis Subject area Diarrhoeal Diseases

504 To study the inflammatory aspect of HIV - 1 clade C tat in vivo 507 Cross cultural reliability and validity of intermediate measures (CIM II)) of the measurement and treatment research to improve cognition in schizophrenia (MATRICS)

Principal Investigator Funded by Principal Investigator Funded by Dr. Sarman Singh University of Rochester, DCFAR, USA Dr. Smita N Deshpande University of Texas, USA Professor & Head, Head of Department, All India Institute of Medical Sciences Dr. Ram Manohar Lohia Hospital, (AIIMS), Ansari Nagar, Baba Kharag Singh Marg, New Delhi-110029 New Delhi-110001 Date of approval March 12, 2012 Date of approval March 12, 2012 Total budget Rs 9, 00, 000 Total budget Rs 16, 80, 000 Duration 12 Months Duration 6 Months Subject area HIV/AIDS/ STD Subject area Mental Health

Indian Council of Medical Research 197 Indian Council of Medical Research 198

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

508 Cross cultural reliability and validity of intermediate measures (CIM II)) of the measurement and treatment research to improve cognition in Schizophrenia (MATRICS)

Principal Investigator Funded by Dr. Ajit Awasthi University of Texas, USA Professor, Post Graduate Institute of Medical Education and Research (PGIMER), Sector 12-D, Date of approval March 12, 2012 Chandigarh-160012 Total budget Rs 16, 80, 000 Duration 6 Months Subject area Mental Health

509 Cross cultural reliability and validity of intermediate measures (CIM II)) of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)

Principal Investigator Funded by Dr. Shiv Gautam University of Texas, USA Director, Institute of Behaviour Sciences and Alternate Medicine, Gokul, Civil lines Phatak, Date of approval March 12, 2012 Jaipur-302001 Total budget Rs 16, 80,000 Duration 6 Months Subject area Mental Health

510 A genetic component to the INDEYE study of cataract and age-related macular degeneration in India

Principal Investigator Funded by Dr. Praveen Vashist Wellcome Trust, United Kingdom Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 2, 2009 * Total budget Rs 6,04,79,92 Duration 24 Months Subject area Ophthalmology

* Approved for AIIMS, New Delhi only

199

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

508 Cross cultural reliability and validity of intermediate measures (CIM II)) of the measurement and 511 Nutritional challenges, abdominal adiposity and type 2 diabetes in Indians treatment research to improve cognition in Schizophrenia (MATRICS)

Principal Investigator Funded by Principal Investigator Funded by Dr. Ajit Awasthi University of Texas, USA Dr. Vijaya Radha Krishna Kankipati Wellcome Trust, United Kingdom Professor, Scientist D, Post Graduate Institute of Medical National Institute of Nutrition (NIN), Education and Research (PGIMER), Jamai Osmania, Tarnaka, Sector 12-D, Hyderabad-500007 Date of approval March 12, 2012 Date of approval March 2, 2009 Chandigarh-160012 Total budget Rs 16, 80, 000 Total budget Rs 80, 35, 750 Duration 6 Months Duration 30 Months Subject area Mental Health Subject area Diabetes

509 Cross cultural reliability and validity of intermediate measures (CIM II)) of the Measurement and 512 Novel approach to determine geographical and genomic barriers to gene flow in a major malaria Treatment Research to Improve Cognition in Schizophrenia (MATRICS) vector

Principal Investigator Funded by Principal Investigator Funded by Dr. Shiv Gautam University of Texas, USA Dr. Anil Prakash Wellcome Trust, United Kingdom Director, Scientist F, Institute of Behaviour Sciences and Regional Medical Research Centre Alternate Medicine, (RMRC), NE Region, Gokul, Civil lines Phatak, Post Box No. 105, Date of approval March 12, 2012 Date of approval September 8, 2009 Jaipur-302001 Dibrugarh-786001 Total budget Rs 16, 80,000 Total budget Rs 55, 17, 520 Duration 6 Months Duration 36 Months Subject area Mental Health Subject area Malaria

510 A genetic component to the INDEYE study of cataract and age-related macular degeneration in 513 Extending the National Nutritional Monitoring Survey (2009-2011) by collection of dried blood India spots for subsequent DNA extraction and creation of a DNA bio-repository for genetic epidemiological studies Principal Investigator Funded by Principal Investigator Funded by Dr. Praveen Vashist Wellcome Trust, United Kingdom Dr. G N V Brahmam Wellcome Trust, United Kingdom Professor, Scientist F, All India Institute of Medical Sciences National Institute of Nutrition (NIN), (AIIMS), Ansari Nagar, Jamai Osmania, Tarnaka, New Delhi-110029 Hyderabad-500007 Date of approval March 2, 2009 * Date of approval June 8, 2010 * Total budget Rs 6,04,79,92 Total budget Rs 2, 85, 70, 000 Duration 24 Months Duration 24 Months Subject area Ophthalmology Subject area Nutrition

* Approved for AIIMS, New Delhi only * Approved with conditions

Indian Council of Medical Research 199 200

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

514 A multi-centric study of measurement of chronic disease risk factors in India

Principal Investigator Funded by Prof. Shah Ebrahim Wellcome Trust, United Kingdom Director, South Asia Network for Chronic Disease (SANCD), PHFI C/52, Date of approval December 8, 2010 * Safdarjung Development Area, New Delhi-110016 Total budget Rs 2, 06, 02, 490 Duration 12 Months Subject area Life Style Diseases

515 The practice of obstetric care in Mumbai: An ethical analysis

Principal Investigator Funded by Dr. Amar Jesani Wellcome Trust, United Kingdom Faculty Member, Center for Studies in Ethics and Rights (CSER), Anusandhan Trust, Sai Ashray, Aaram Society Road, Date of approval March 8, 2011* Vakola, Santa Cruz Mumbai-400055 Total budget Rs 5,81,97,80 Duration 24 Months Subject area Reproductive Health

516 Developing and evaluation of signature mapping detection system for automated detection of AFB using Zeil-Neelsen stain and bright field microscope

Principal Investigator Funded by Dr. D Behera Wellcome Trust, United Kingdom Director, LRS Institute of TB & Respiratory Diseases, Sri Aurobindo Marg, Near Qutub Minar, Date of approval June 8, 2011 New Delhi-110030 Total budget Rs 1, 10, 43, 800 Duration 24 Months Subject area Tuberculosis

* Approved with conditions ** Approved for five study sites only

201

Research Projects Approved by HMSC Research Projects Approved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

514 A multi-centric study of measurement of chronic disease risk factors in India 517 The course and outcome of Alcohol Use Disorders (AUD): A population based cohort study in Goa

Principal Investigator Funded by Principal Investigator Funded by Prof. Shah Ebrahim Wellcome Trust, United Kingdom Dr. Vikram Patel Wellcome Trust, United Kingdom Director, Professor, South Asia Network for Chronic Sangath Centre, Disease (SANCD), 841/1 Alto Porvorim, PHFI C/52, Goa-403521 Date of approval December 8, 2010 * Date of approval September 8, 2011 Safdarjung Development Area, New Delhi-110016 Total budget Rs 2, 06, 02, 490 Total budget Rs 1, 00, 35, 586 Duration 12 Months Duration 36 Months Subject area Life Style Diseases Subject area Life Style Diseases

515 The practice of obstetric care in Mumbai: An ethical analysis 518 A cluster randomized trial to evaluate an intervention to change hand washing behavior in rural Indian households

Principal Investigator Funded by Principal Investigator Funded by Dr. Amar Jesani Wellcome Trust, United Kingdom Dr. Divya Rajaraman Wellcome Trust, United Kingdom Faculty Member, Assistant Professor, Center for Studies in Ethics and Rights St. Johns Medical College, St. Johns (CSER), Anusandhan Trust, Research Institute, Sai Ashray, Aaram Society Road, Date of approval March 8, 2011* St. Johns National Academy of Health Date of approval December 8, 2011 Vakola, Santa Cruz Sciences, Mumbai-400055 Total budget Rs 5,81,97,80 Koramangala, Sarjapur Road, Total budget Rs 45, 72, 300 Duration 24 Months Bangalore-560034 Duration 18 Months Subject area Reproductive Health Subject area Social & Behavioural Research 516 Developing and evaluation of signature mapping detection system for automated detection of 519 PREMIUM, a PRogramme for Effective Mental health Interventions in Under resourced health AFB using Zeil-Neelsen stain and bright field microscope systeMs

Principal Investigator Funded by Principal Investigator Funded by Dr. D Behera Wellcome Trust, United Kingdom Dr. Vikram Patel Wellcome Trust, United Kingdom Director, Professor, LRS Institute of TB & Respiratory Diseases, Sangath Centre, Sri Aurobindo Marg, 841/1 Alto Porvorim, Near Qutub Minar, Goa-403521 Date of approval June 8, 2011 Date of approval December 8, 2011 New Delhi-110030 Total budget Rs 1, 10, 43, 800 Total budget Rs 6, 84, 12, 554 Duration 24 Months Duration 60 Months Subject area Tuberculosis Subject area Mental Health

* Approved with conditions ** Approved for five study sites only

Indian Council of Medical Research 201 202

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

520 Developmental programming of the Hypothalamic Pituitary Adrenal (HPA) axis and cardiovascular and congnitive outcomes in adolescent Indian children

Principal Investigator Funded by Dr. G V Krishnaveni Wellcome Trust, United Kingdom Epidemiologist & Research Fellow, CSI Holdsworth Memorial Hospital, Sawday Road, Mandi Mohalla, Mysore- 570021 Date of approval September 10, 2012* Total budget Rs 1, 63, 55, 250 Duration 36 Months Subject area Cardiovascular Diseases

521 Studies in the diagnosis and pathophysiology of corneal necrosis in severe microbial keratitis

Principal Investigator Funded by Dr. N Venkatesh Prajna Wellcome Trust, United Kingdom Director of Corneal Service, Aravind Eye Hospital & PG Institute of Ophthalmology, 1, Annanagar, Madurai-625020 Date of approval September 10, 2012 Total budget Rs 27, 03, 846 Duration 24 Months Subject area Ophthalmology

522 Implementation of MODS for TB and MDR-TB control: Towards sustainable rollout

Principal Investigator Funded by Dr. Suniti Solomon World Bank, USA Director, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Taramani, Date of approval March 2, 2009 Chennai-600113 March 2, 2009 Total budget Rs 30, 32, 000 Duration 24 Months Subject area Tuberculosis

* Approved for CSI Holdsworth Memorial Hospital, Mysore only

203

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

520 Developmental programming of the Hypothalamic Pituitary Adrenal (HPA) axis and 523 Treatment of mild to moderate hypertension for the prevention of preeclampsia: A multicentre cardiovascular and congnitive outcomes in adolescent Indian children randomized clinical trial

Principal Investigator Funded by Principal Investigator Funded by Dr. G V Krishnaveni Wellcome Trust, United Kingdom Dr. Alice George World Health Organization Epidemiologist & Research Fellow, Professor, CSI Holdsworth Memorial Hospital, Christian Medical College & Hospital, Sawday Road, Mandi Mohalla, Ida Scudder Road, Vellore-632004 Mysore- 570021 Date of approval September 10, 2012* Date of approval March 25, 2008 Total budget Rs 1, 63, 55, 250 Total budget Rs 11, 25, 000 Duration 36 Months Duration 24 Months Subject area Cardiovascular Diseases Subject area Reproductive Health

521 Studies in the diagnosis and pathophysiology of corneal necrosis in severe microbial keratitis 524 Quality and quantity optimization of calotropin, a larvicide against dengue vectors in-vitro and in- vivo plant stocks

Principal Investigator Funded by Principal Investigator Funded by Dr. N Venkatesh Prajna Wellcome Trust, United Kingdom Dr. Manju Singhi World Health Organization Director of Corneal Service, Scientist C, Aravind Eye Hospital & PG Institute of Desert Medicine Research Centre, Ophthalmology, 1, Annanagar, New Pali Road, Madurai-625020 Jodhpur-342005 Date of approval September 10, 2012 Date of approval March 25, 2008 Total budget Rs 27, 03, 846 Total budget Rs 7, 32, 735 Duration 24 Months Duration 24 Months Subject area Ophthalmology Subject area Dengue

522 Implementation of MODS for TB and MDR-TB control: Towards sustainable rollout 525 Laboratory based evaluation of rapid diagnostic tests for Visceral Leishmaniasis (VL)

Principal Investigator Funded by Principal Investigator Funded by Dr. Suniti Solomon World Bank, USA Dr. Pradeep Das World Health Organization Director, Scientist G & Director, Y R Gaitonde Centre for AIDS Rajendra Memorial Research Institute Research and Education (YRG CARE), of Medical Sciences (RMRIMS), Voluntary Health Services, Taramani, Agam-kuan, Date of approval March 2, 2009 Date of approval June 23, 2008 Chennai-600113 Patna-800007 March 2, 2009 Total budget Rs 30, 32, 000 Total budget Rs 37, 20, 000 Duration 24 Months Duration 24 Months Subject area Tuberculosis Subject area Leishmaniasis

* Approved for CSI Holdsworth Memorial Hospital, Mysore only

Indian Council of Medical Research 203

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

526 Capacity strengthening for testing and evaluation of Public Health Pesticides (PHPs) in India and to develop World Health Organization collaborating centre for their testing and evaluation in this region Principal Investigator Funded by Dr. K Raghavendra World Health Organization Scientist E, National Institute of Malaria Research (NIMR), 22, Sham Nath Marg, New Delhi-110054 Date of approval December 22, 2008 Total budget Rs 8, 00, 000 Duration 36 Months Subject area Malaria

527 Phase III evaluation to compare insecticidal efficacy and community acceptance of long-lasting insecticidal net Dura Net® with conventional insecticide treated nets in India

Principal Investigator Funded by Dr. S K Sharma World Health Organization Scientist E, National Institute of Malaria Research (NIMR), Field Station, Rourkela-769002 Date of approval December 22, 2008 Total budget Rs 16, 31, 925 Duration 36 Months Subject area Malaria

528 Asian centre for training in biosafety assessment for human health and environment using genetically modified vectors

Principal Investigator Funded by Dr. B K Tyagi World Health Organization Scientist F & Officer in Charge, Centre for Research in Medical Entomology (CRME), 4, Sarojani Street, Date of approval March 2, 2009 Chinna Chokkikulam, Madurai-625002 Total budget Rs 75, 00, 000 Duration 36 Months Subject area Vector Borne Disease

205

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

526 Capacity strengthening for testing and evaluation of Public Health Pesticides (PHPs) in India and 529 Investigating provider level factors facilitating and impeding women's access to medical abortion to develop World Health Organization collaborating centre for their testing and evaluation in this in India region Principal Investigator Funded by Principal Investigator Funded by Dr. K Raghavendra World Health Organization Dr. Rajib Acharya World Health Organization Scientist E, Progamme Officer, National Institute of Malaria Research Population Council South & East Asia- (NIMR), 22, Sham Nath Marg, Regional Office, New Delhi-110054 Zone 5 A, Ground Floor, Date of approval December 22, 2008 Date of approval March 2, 2009 India Habitat Centre, Lodi Road, Total budget Rs 8, 00, 000 New Delhi-110003 Total budget Rs 30, 57,327 Duration 36 Months Duration 12 Months Subject area Malaria Subject area Reproductive Health

527 Phase III evaluation to compare insecticidal efficacy and community acceptance of long-lasting 530 Post abortion contraception following medical and surgical abortion in India insecticidal net Dura Net® with conventional insecticide treated nets in India

Principal Investigator Funded by Principal Investigator Funded by Dr. S K Sharma World Health Organization Mrs. Shveta Kalyanwala World Health Organization Scientist E, Senior Programme Officer, National Institute of Malaria Research Population Council South & East Asia- (NIMR), Field Station, Regional Office, Rourkela-769002 Zone 5 A, Ground Floor, Date of approval December 22, 2008 Date of approval March 2, 2009 India Habitat Centre, Lodi Road, Total budget Rs 16, 31, 925 New Delhi-110003 Total budget Rs 35, 21,320 Duration 36 Months Duration 18 Months Subject area Malaria Subject area Reproductive Health

528 Asian centre for training in biosafety assessment for human health and environment using 531 Active management of the third stage of labour without controlled cord traction: A randomized genetically modified vectors non-inferiority controlled trial

Principal Investigator Funded by Principal Investigator Funded by Dr. B K Tyagi World Health Organization Dr. Bhalachandra S Kodkany World Health Organization Scientist F & Officer in Charge, Professor, Centre for Research in Medical Jawaharlal Nehru Medical College, Entomology (CRME), JNMC Campus, Nehru Nagar, 4, Sarojani Street, Belgaum-590010 Date of approval March 2, 2009 Date of approval June 8, 2009 Chinna Chokkikulam, Madurai-625002 Total budget Rs 75, 00, 000 Total budget Rs 34, 79,658 Duration 36 Months Duration 36 Months Subject area Vector Borne Disease Subject area Reproductive Health

Indian Council of Medical Research 205 Indian Council of Medical Research 206

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

532 Pivotal (phase II/III) study to evaluate the immunogenicity and safety of a measles vaccine given by aerosol inhalation: A randomized controlled trail

Principal Investigator Funded by Dr. Siddhivinayak Hirve World Health Organization Director, Shirdi Sai Baba Rural Hospital, Vadu Budruk Village, Shirur Block, Pune-412216 Date of approval September 8, 2009 Total budget Rs 4, 86, 79,876 Duration 24 Months Subject area Other Infectious Diseases

533 Sperm suppression and contraceptive protection provided by NorEThisterone ENantate (NET- EN) combined with Testosterone Undecanoate (TU) in healthy men

Principal Investigator Funded by Dr. Deoki Nandan World Health Organization Director, National Institute of Health and Family Welfare, Baba Gang Nath Marg, Munirka, Date of approval September 8, 2009 New Delhi-110067 Total budget Rs 87, 38,478 Duration 42 Months Subject area Reproductive Health

534 A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL evidence-based medicine course

Principal Investigator Funded by Dr. Suneeta Mittal World Health Organization Professor & Head, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029 Date of approval March 8, 2010 Total budget Rs 10, 58,762 Duration 12 Months Subject area Reproductive Health

207

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

532 Pivotal (phase II/III) study to evaluate the immunogenicity and safety of a measles vaccine given 535 Field evaluation to compare efficacy of spinosad (natular 20% EC) with spinosad 12 % SC as by aerosol inhalation: A randomized controlled trail mosquito larvicide in Gujarat, India

Principal Investigator Funded by Principal Investigator Funded by Dr. Siddhivinayak Hirve World Health Organization Dr. V K Dua World Health Organization Director, Scientist F, Shirdi Sai Baba Rural Hospital, National Institute of Malaria Research Vadu Budruk Village, Shirur Block, (NIMR), Sector 8, Dwarka, Pune-412216 New Delhi-110077 Date of approval September 8, 2009 Date of approval March 8, 2010 Total budget Rs 4, 86, 79,876 Total budget Rs 9, 56,428 Duration 24 Months Duration 12 Months Subject area Other Infectious Diseases Subject area Malaria

533 Sperm suppression and contraceptive protection provided by NorEThisterone ENantate (NET- 536 Phase III evaluation to compare insecticidal efficacy and community acceptance of long-lasting EN) combined with Testosterone Undecanoate (TU) in healthy men insecticidal nets with conventional insecticidal treated nets in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Deoki Nandan World Health Organization Dr. S S Sahu World Health Organization Director, Scientist C, National Institute of Health and Family Vector Control Research Centre Welfare, (VCRC), Medical Complex, Baba Gang Nath Marg, Munirka, Indira Nagar, Date of approval September 8, 2009 Date of approval June 8, 2010 New Delhi-110067 Puducherry-605006 Total budget Rs 87, 38,478 Total budget Rs 28, 85,202 Duration 42 Months Duration 36 Months Subject area Reproductive Health Subject area Malaria

534 A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated RHL 537 Proposal for Regional Training Center (RTC) in health research evidence-based medicine course

Principal Investigator Funded by Principal Investigator Funded by Dr. Suneeta Mittal World Health Organization Dr. Pradeep Das World Health Organization Professor & Head, Scientist G & Director, All India Institute of Medical Sciences Rajendra Memorial Research Institute (AIIMS), Ansari Nagar, of Medical Sciences (RMRIMS), New Delhi-110029 Agam-kuan, Date of approval March 8, 2010 Date of approval June 8, 2010 Patna-800007 Total budget Rs 10, 58,762 Total budget Rs 36, 00,000 Duration 12 Months Duration 36 Months Subject area Reproductive Health Subject area Leishmaniasis

Indian Council of Medical Research 207 Indian Council of Medical Research 208

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

538 Understanding women's perspectives on medical abortion - A research study

Principal Investigator Funded by Dr. B Subha Sri World Health Organization Director, Rural Womens Social Education (RUWSEC), 191-A Nehru Nagar, Villam Post, Date of approval June 8, 2010 Chengalpattu- 603002, Tamil Nadu Total budget Rs 10, 80,000 Duration 18 Months Subject area Reproductive Health

539 Impact of insecticide resistance in malaria vectors on the effectiveness of combination of Indoor Residual Spraying (IRS) and Long Lasting Insecticidal Nets (LLINs) in India

Principal Investigator Funded by Dr. V K Dua World Health Organization/ Bill & Melinda Gates Foundation, USA Scientist F, Director,National Institute of Malaria Research (NIMR), Sector 8, Dwarka, New Delhi-110077 Date of approval September 8, 2010 * Total budget Rs 5, 13, 96,766 Duration 60 Months Subject area Malaria

540 Phase III evaluation to compare insecticidal efficacy, longevity, fabric integrity and community acceptance of long-lasting insecticidal net PermaNet® 3.0 with PermaNet® 2.0 and conventional deltamethrin treated nets in India Principal Investigator Funded by Dr. V K Dua World Health Organization Scientist F, DirectorNational- inInstitute-Charge, of Malaria Research (NIMR), Sector 8, Dwarka, New Delhi-110077 Date of approval September 8, 2010 Total budget Rs 28, 85,762 Duration 36 Months Subject area Malaria

* The approval of HMSC was obtained on December 10, 2012 for few modifications like change of funding source to BMGF, budget, duration, study site etc

209

Research Projects Approved by HMSC ResearchResearch ProjectsProjects Approved Approved by by HMSC HMSC

S.no. Detail of Projects S.no. Detail of Projects

538 Understanding women's perspectives on medical abortion - A research study 541 Cluster - randomized village scale phase III evaluation of deltamethrin SC62.5 g ai/L for indoor residual spraying against Anopheles minimus s.l., the major malaria vector in North-East India

Principal Investigator Funded by Principal Investigator Funded by Dr. B Subha Sri World Health Organization Dr. Anil Prakash World Health Organization Director, Assistant Director, Rural Womens Social Education Regional Medical Research Centre (RUWSEC), (RMRC), NE Region, 191-A Nehru Nagar, Villam Post, Post Box No -105, Date of approval June 8, 2010 Date of approval March 8, 2011 Chengalpattu- 603002, Tamil Nadu Dibrugarh-786001 Total budget Rs 10, 80,000 Total budget Rs 22, 93, 300 Duration 18 Months Duration 12 Months Subject area Reproductive Health Subject area Malaria

539 Impact of insecticide resistance in malaria vectors on the effectiveness of combination of Indoor 542 Point of care diagnosis and treatment with single dose liposomal amphotericin B for visceral Residual Spraying (IRS) and Long Lasting Insecticidal Nets (LLINs) in India leishmaniasis

Principal Investigator Funded by Principal Investigator Funded by Dr. V K Dua World Health Organization/ Bill & Melinda Dr. Shyam Sundar World Health Organization Gates Foundation, USA Scientist F, Professor, Director,National Institute of Malaria Research Institute of Medical Sciences, (NIMR), Sector 8, Dwarka, Banaras Hindu University, New Delhi-110077 Varanasi-221005 Date of approval September 8, 2010 * Date of approval March 8, 2011 Total budget Rs 5, 13, 96,766 Total budget Rs 6, 76, 44, 400 Duration 60 Months Duration 24 Months Subject area Malaria Subject area Leishmaniasis

540 Phase III evaluation to compare insecticidal efficacy, longevity, fabric integrity and community 543 Small-scale field testing and evaluation to compare residual efficacy of pirimiphos-methy CS acceptance of long-lasting insecticidal net PermaNet® 3.0 with PermaNet® 2.0 and conventional (Actellic 30% CS) with pirimipos-methyl 50% EC by indoor residual spraying on different local deltamethrin treated nets in India indoor surfaces in Gujarat, India Principal Investigator Funded by Principal Investigator Funded by Dr. V K Dua World Health Organization Dr. H C Srivastava World Health Organization Scientist F, Scientist E, DirectorNational- inInstitute-Charge, of Malaria Research Natonal Institute of Malaria Research (NIMR), Sector 8, Dwarka, (NIMR), Field station, Civil Hospital, New Delhi-110077 Date of approval March 8, 2011 Date of approval September 8, 2010 Nadiad-110077, Gujarat Total budget Rs 28, 85,762 Total budget Rs 9, 82, 421 Duration 36 Months Duration 12 Months Subject area Malaria Subject area Malaria

* The approval of HMSC was obtained on December 10, 2012 for few modifications like change of funding source to BMGF, budget, duration, study site etc

Indian Council of Medical Research 209 Indian Council of Medical Research 210

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

544 Evaluation of olyset plus a permethrin long lasting insecticidal mosquito net susceptible malaria vector populations in experimental huts in Orissa, East -Central India

Principal Investigator Funded by Dr. K Gunasekaran World Health Organization Scientist E, Vector Control Research Centre (VCRC), Medical Complex, Indira Nagar, Puducherry-605006 Date of approval June 8, 2011* Total budget Rs 21, 11, 625 Duration 12 Months Subject area Malaria

545 Field evaluation of vectobac 4.95% GR, a granular formulation of Bacillus thuringiensis israelensis with a new carrier ingredient against Culex quinquefasciatus Say in polluted water habitats in India

Principal Investigator Funded by Dr. C Sadanandane World Health Organization Technical Officer, Vector Control Research Centre (VCRC), Medical Complex, Indira Nagar, Puducherry-605006 Date of approval June 8, 2011 Total budget Rs 7, 42, 500 Duration 12 Months Subject area Malaria

546 Medical abortion provision in Bihar and Jharkhand States, India

Principal Investigator Funded by Dr. K K Singh World Health Organization Lecturer, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 Date of approval June 8, 2011 Total budget Rs 26, 86, 000 Duration 12 Months Subject area Reproductive Health

* Approved with conditions

Indian Council of Medical Research 211

Research Projects Approved by HMSC ResearchResearch Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

544 Evaluation of olyset plus a permethrin long lasting insecticidal mosquito net susceptible malaria 547 A scalable approach to improve the coverage, quality and impact of MNCH care in the urban vector populations in experimental huts in Orissa, East -Central India slums of Delhi: Developing a package of MNCH care facilitated through an urban community health worker: The ANCHUL project (Ante Natal and Child Health care in Urban Slums)

Principal Investigator Funded by Principal Investigator Funded by Dr. K Gunasekaran World Health Organization Dr. Sanjay Zodpey World Health Organization Scientist E, Director, Vector Control Research Centre (VCRC), Public Health Foundation, PHD House Medical Complex, Indira Nagar, 2nd Floor, 4/2 Sirifort Institutional Puducherry-605006 Area, August Kranti Marg, Date of approval June 8, 2011* Date of approval September 8, 2011 New Delhi-110016 Total budget Rs 21, 11, 625 Total budget Rs 2, 22, 91, 962 Duration 12 Months Duration 36 Months Subject area Malaria Subject area Child Health

545 Field evaluation of vectobac 4.95% GR, a granular formulation of Bacillus thuringiensis 548 Evaluation of LifeNet, a deltamethrin long-lasting insecticidal mosquito net in experimental huts israelensis with a new carrier ingredient against Culex quinquefasciatus Say in polluted water (Phase II) against susceptible malaria vector populations in Orissa, East-Central India habitats in India

Principal Investigator Funded by Principal Investigator Funded by Dr. C Sadanandane World Health Organization Dr. K Gunasekaran World Health Organization Technical Officer, Scientist E, Vector Control Research Centre (VCRC), Vector Control Research Centre (VCRC), Medical Complex, Indira Nagar, Medical Complex, Indira Nagar, Puducherry-605006 Puducherry-605006 Date of approval June 8, 2011 Date of approval September 8, 2011 Total budget Rs 7, 42, 500 Total budget Rs 17, 97, 750 Duration 12 Months Duration 6 Months Subject area Malaria Subject area Malaria

546 Medical abortion provision in Bihar and Jharkhand States, India 549 Phase III evaluation to compare insecticidal efficacy and household acceptability of DawaPlus® 2.0 long-lasting insecticidal mosquito nets with conventional deltamethrin treated nets in India

Principal Investigator Funded by Principal Investigator Funded by Dr. K K Singh World Health Organization Dr. R M Bhatt World Health Organization Lecturer, Office in Charge, Institute of Medical Sciences, National Institute of Malaria Research Banaras Hindu University, (NIMR), Field Unit, RLTRI, Varanasi-221005 Raipur-492015 Date of approval June 8, 2011 Date of approval September 8, 2011 Total budget Rs 26, 86, 000 Total budget Rs 24, 75, 019 Duration 12 Months Duration 36 Months Subject area Reproductive Health Subject area Malaria

* Approved with conditions

Indian Council of Medical Research 211 212

Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects

550 Randomised village-scale evaluation to compare the efficacy of two different dosages of chlorfenapyr SC used in indoor residual spraying for malaria vector control in Chhattisgarh state, India Principal Investigator Funded by Dr. R M Bhatt World Health Organization Scientist E & Officer –in-Charge, National Institute of Malaria Research (NIMR), Field Unit, RLTRI, Raipur-492015 Date of approval September 8, 2011 Total budget Rs 27, 48, 229 Duration 12 Months Subject area Malaria

551 Cross cultural development of a depression identification instrument for SEARO

Principal Investigator Funded by Dr. Pratap Sharan World Health Organization Professor, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi- 110029 Date of approval December 8, 2011 Total budget Rs 14, 78, 000 Duration 12 Months Subject area Mental Health

552 Field evaluation (phase II and phase III) of VectoBac GR, a granular formulation, against Anopheles stephensi in clean water habitats and Culex quinquefasciatus in polluted water habitats in Goa, India

Principal Investigator Funded by Dr. Ashwani Kumar World Health Organization Scientist E & Officer -in-Charge, National Institute of Malaria Research (NIMR), Field Station, Panaji, Goa-403001 Date of approval December 8, 2011 Total budget Rs 9, 18, 697 Duration 9 Months Subject area Malaria

213

Research Projects Approved by HMSC Research Projects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

550 Randomised village-scale evaluation to compare the efficacy of two different dosages of 553 A55036: Screening for preeclampsia: Evaluation of the predictive ability of angiogenic factors for chlorfenapyr SC used in indoor residual spraying for malaria vector control in Chhattisgarh state, preeclampsia India

Principal Investigator Funded by Principal Investigator Funded by Dr. R M Bhatt World Health Organization Dr. Shalini Fusey World Health Organization Scientist E & Officer –in-Charge, Associate Professor, National Institute of Malaria Research Government Medical College, (NIMR), Field Unit, RLTRI, Opposite Ramakrishna Mission, Raipur-492015 Nagpur-440012 Date of approval September 8, 2011 Date of approval March 12, 2012* Total budget Rs 27, 48, 229 Total budget Not Requested Duration 12 Months Duration 30 Months Subject area Malaria Subject area Reproductive Health

551 Cross cultural development of a depression identification instrument for SEARO 554 A randomized village - scale evaluation to compare the efficacy of Pirimiphos-methyl CS (300g AI/L with Pirimiphos-methyl EC (500g AI/L) used in indoor residual spraying for malaria vector control in Gujarat State, India

Principal Investigator Funded by Principal Investigator Funded by Dr. Pratap Sharan World Health Organization Dr. H C Srivastava World Health Organization Professor, Scientist E, All India Institute of Medical Sciences National Institute of Malaria Research (AIIMS), Ansari Nagar, (NIMR), Sector 8, Dwarka, New Delhi- 110029 New Delhi-110077 Date of approval December 8, 2011 Date of approval March 12, 2012 ** Total budget Rs 14, 78, 000 Total budget Rs 26, 40, 462 Duration 12 Months Duration 15 Months Subject area Mental Health Subject area Malaria

552 Field evaluation (phase II and phase III) of VectoBac GR, a granular formulation, against 555 Small scale evaluation of the efficacy and residual activity of alphacypermethrin WG (250 g a.i. / Anopheles stephensi in clean water habitats and Culex quinquefasciatus in polluted water habitats kg) for indoor spraying in comparison with alphacypermethrin WP (50 g a.i. / kg) in India in Goa, India

Principal Investigator Funded by Principal Investigator Funded by Dr. Ashwani Kumar World Health Organization Dr. U Sreehari World Health Organization Scientist E & Officer -in-Charge, Scientist B, National Institute of Malaria Research National Institute of Malaria Research (NIMR), Field Station, Panaji, (NIMR), Sector 8, Dwarka, Goa-403001 New Delhi-110077 Date of approval December 8, 2011 Date of approval March 12, 2012 Total budget Rs 9, 18, 697 Total budget Rs 7, 87, 803 Duration 9 Months Duration 10 Months Subject area Malaria Subject area Malaria

* Approved for transfer of biological samples collected under a study already approved by HMSC in 2006. No funds are required for the current proposal ** Modification in the study was endorsed in HMSC meeting held on December 10, 2012

Indian Council of Medical Research 213

Research Projects Approved by HMSC Research Projects Approved by HMSC Research Projects Approved by HMSC

S.no. Detail of Projects S.no. Detail of Projects

556 WHO - AIIMS study for the development of growth standards from fetal life to childhood: The 559 Small and large scale evaluation of NatularTM T30 and G30 formulations against immature of fetal component Culex species in polluted water habitats in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Suneeta Mittal World Health Organization Dr. C Sadanandane World Health Organization Professor & Unit Head, Technical Officer, All India Institute of Medical Sciences Vector Control Research Centre (AIIMS), Ansari Nagar, (VCRC), Medical Complex, New Delhi-110029 Indira Nagar, Date of approval March 12, 2012 Date of approval December 10, 2012 Puducherry-605006 Total budget Rs 14, 72, 287 Total budget Rs 14, 08, 000 Duration 18 Months Duration 15 Months Subject area Child Health Subject area Filariasis

557 Attitudes towards and outcomes of pregnancy among women living with HIV / AIDS in Karnataka, India

Principal Investigator Funded by Dr. C G Hussain Khan World Health Organization Professor, Karnataka University, Pavate Nagar, Dharwad-580003 Date of approval June 18, 2012 Total budget Rs 27, 82,687 Duration 18 Months Subject area HIV/AIDS/ STD

558 Assessment of durability of LifeNet long lasting insecticidal nets in a phase III study in Madhya Pradesh, India

Principal Investigator Funded by Dr. Neena Valecha World Health Organization Scientist G & Director, National Institute of Malaria Research (NIMR), Sector-8, Dwarka, New Delhi-110077 Date of approval December 10, 2012 * Total budget Rs 31, 87, 729 Duration 33 Months Subject area Malaria

* Approved with conditions

215 Indian Council of Medical Research 216

Research Projects Approved by HMSC ResearchResearch ProjectsProjects ApprovedApproved byby HMSCHMSC

S.no. Detail of Projects S.no. Detail of Projects

556 WHO - AIIMS study for the development of growth standards from fetal life to childhood: The 559 Small and large scale evaluation of NatularTM T30 and G30 formulations against immature of fetal component Culex species in polluted water habitats in India

Principal Investigator Funded by Principal Investigator Funded by Dr. Suneeta Mittal World Health Organization Dr. C Sadanandane World Health Organization Professor & Unit Head, Technical Officer, All India Institute of Medical Sciences Vector Control Research Centre (AIIMS), Ansari Nagar, (VCRC), Medical Complex, New Delhi-110029 Indira Nagar, Date of approval March 12, 2012 Date of approval December 10, 2012 Puducherry-605006 Total budget Rs 14, 72, 287 Total budget Rs 14, 08, 000 Duration 18 Months Duration 15 Months Subject area Child Health Subject area Filariasis

557 Attitudes towards and outcomes of pregnancy among women living with HIV / AIDS in Karnataka, India

Principal Investigator Funded by Dr. C G Hussain Khan World Health Organization Professor, Karnataka University, Pavate Nagar, Dharwad-580003 Date of approval June 18, 2012 Total budget Rs 27, 82,687 Duration 18 Months Subject area HIV/AIDS/ STD

558 Assessment of durability of LifeNet long lasting insecticidal nets in a phase III study in Madhya Pradesh, India

Principal Investigator Funded by Dr. Neena Valecha World Health Organization Scientist G & Director, National Institute of Malaria Research (NIMR), Sector-8, Dwarka, New Delhi-110077 Date of approval December 10, 2012 * Total budget Rs 31, 87, 729 Duration 33 Months Subject area Malaria

* Approved with conditions

Indian Council of Medical Research 215 Indian Council of Medical Research 216