CoNTeNTS
FOREWORD 03 A MESSAGE FROM OUR CO-DIRECTORS 04 HIV-NAT CLINICAL TRIALS NETWORK 05 INTERNATIONAL ADVISORY BOARD 2012 06 COLLABORATORS 07
OVERVIEW OF HIV-NAT STUDIES 10 PHARMACOKINETIC STUDIES 14 CLINICAL RESEARCH PROGRAMS IN CO-VIRAL & VIRAL INFECTIONS 15 CLINICAL RESEARCH PROGRAMS IN CO-TUBERCULOSIS INFECTIONS 19 LONG TERM COHORT ANALYSIS 20 STRATEGY STUDIES 23 NEW DRUG DEVELOPMENT 26 SEXUAL HEALTH 28 OTHERS 29 PEDIATRIC AND YOUTH RESEARCH PROGRAMS 31
HIV-NAT TEAMS 36
PUBLICATIONS & WRITINGS 40 PRESENTATIONS AT CONFERENCES AND MEETINGS 45
HIV-NAT RESEARCH LABORATORY 50 THE VACCINE & CELLULAR IMMUNOLOLGY LABORATORY 54
EDUCATION & DEVELOPMENT PROGRAM 56
15TH THE BANGKOK INTERNATIONAL SYMPOSIUM ON HIV MEDICINE 60
PARTNERSHIPS 62
COMMUNITY OUTREACH PROGRAMS 77 ACKNOWLEDGEMENTS 83 SPONSORS 84 2 H I V - N A T ANNUAL REPORT 2 0 1 2 Foreword
It gives me great pride to present the 16th annual report rom the HIV Netherlands Australia Thailand Research Collaboration. Its pages highlight the dedication and proessionalism HIV-NAT Phan Wannamethee possesses in fghting HIV/AIDS through dierent Secretary General Tai Red Cross Society avenues o research, knowledge dissemination, activities and campaigns.
HIV-NA started the year with the 15th Bangkok International Symposium on HIV Medicine in January, which was attended by more than 700 physicians rom all over the world. Additionally, various trainings on HIV/AIDS were organized throughout the year to disseminate knowledge and inormation on clinical research and HIV inection management to health care proessionals rom Tailand and 9 countries in the region. Troughout 2012 HIV-NA has stayed committed to improving HIV care in Tailand and Southeast Asia through cutting edge research and quality training or health care providers. Results rom research conducted at HIV-NA have been recognized in national and international treatment guidelines. HIV-NA also engaged in public awareness activities. Tese included events that promote non-stigmatization and non-discrimination o people living with HIV that strive to improve quality o lie or people living with HIV. HIV-NA and the Tai Red Cross AIDS Research Centre joined hands with the Ministry o Public Health, UNAIDS, the Bangkok Metropolitan Administration and various NGOs in advancing Tailand towards the ‘Getting to Zero’ goal. A series o seminars that targeted ‘Getting to Zero’ messages, where zero reers to zero deaths, zero new inections and zero discrimination, were organized. Tis created a orum or private businesses, the media, entertainment companies, people living with HIV, HIV/AIDS experts and policy makers to voice shared opinions. Common ground was created and brainstorming was used to harness ideas that will drive Tailand’s move toward zero.
Te ‘Wish Your Love’ undraising campaign or HIV-positive children and amilies was also launched in 2012. Tis was made possible by many actors and celebrities, and a generous public who endorsed the campaign.
HIV-NA has grown and achieved much in 2012. However, the organization and its special ocus as a research acility or HIV/AIDS will continue to stay true to its vision o becoming a leading center o training or HIV/AIDS and a champion or “Getting to Zero”. Essentially, the success o 2012 acts as a catalyst or HIV-NA. I believe that 2013 will see HIV-NA gaining greater ground in Southeast Asia and the world or lie saving research that will enable increased access to treatment or people living with HIV.
Phan Wannamethee Secretary General, Tai Red Cross Society Chairman, HIV-NA international Advisory Board
H I V - N A T ANNUAL REPORT 2 0 1 2 3 A MeSSAGe FroM oUr Co-dIreCTorS
(let to right) Joep M.A. Lange Praphan Phanuphak David A. Cooper
2012 has been an extraordinary year o growth or research at HIV-NAT. Seventy-two clinical studies were conducted this year alone. HIV-NAT continues to be the country coordinator or US National Institutes o Health-unded trials on when to start antiretrovirals in adults (START) and in children (PREDICT). Through the Kirby Institute o Inection and Immunity, HIV-NAT is coordinating multi-site randomized clinical trials on appropriate dosing o ART (LASA, ENCORE) and regimen or second line. By partnering with amAR/Treat Asia, the frst hepatitis C treatment study will be available to patients in Thailand in 2013. Through close collaboration with the TREAT Asia Network, HIV-NAT is the regional coordinating center or several pediatric studies in 4 countries in South East Asia. In 2012, HIV-NAT published 43 articles in peer-reviewed journals including the Lancet Inectious Disease publication o the PREDICT study results. HIV-NAT is committed to improving knowledge to better the care delivered to adults and children with HIV in Thailand and the region.
We now have 110 sta who work tirelessly to RCARC has begun the frst est and reat study in advance HIV research and provide care to almost Tai men who have sex with men (MSM). HIV-NA/ 2000 adults and children with HIV at our center. RCARC is coordinating a study to promote HIV testing We recognize the medical, fnancial and social and linkage to care in MSM rom Bangkok, Jakarta challenges children and amilies with HIV ace, and and Indonesia. We are committed to working towards HIV-NA launched the ‘Wish Your Love’ undraising achieving UNAIDS’s goal o zero new HIV inection. campaign in August 2012 to help these vulnerable children and youth reach their greatest potential. Finally, we hope that you will fnd this annual report inormative and we welcome national and international We are delighted to welcome Proessor Frits van collaboration. On behal o the HIV-NA team, we Griensven to our organization as the Senior Advisor would like to extend our gratitude to collaborators on HIV Prevention. Dr. Frits is a world renowned and sponsors or their unwavering support and to expert in HIV epidemiology and HIV prevention. our patients or their continued support, commitment He will play an important role in HIV-NA and Te and participation in studies. Tai Red Cross AIDS Research Centre (RCARC)’s goal to reduce new HIV inections in Tailand and in the region. In collaboration with the Ministry o Public Health, HIV-NA/
4 H I V - N A T ANNUAL REPORT 2 0 1 2 HIV-NAT CLINICAL TRIALS NETWORK
CHIANG MAI CHIANG RAI • NAKORNPING HOSPITAL • CHIANG RAI PRACHANUKROH HOSPITAL • SANPATONG HOSPITAL
KHON KAEN • SRINAGARIND HOSPITAL, KHON KAEN UNIVERSITY • KHON KAEN HOSPITAL
BANGKOK • HIV-NAT – TRCARC • CHULALONGKORN HOSPITAL • SIRIRAJ HOSPITAL, MAHIDOL UNIVERSITY • BAMRASNARADURA INSTITUTE • RAMATHIBODHI HOSPITAL • BANGKOK METROPOLITAN ADMINISTRATION MEDICAL COLLEGE & VAJIRA HOSPITAL • TAKSIN HOSPITAL
CHON BURI • CHONBURI REGIONAL HOSPITAL • QUEEN SAVANG VADHANA MEMORIAL HOSPITAL
CHANTABURI • PRAPOKKLAO HOSPITAL
PHNOM PENH • NATIONAL PEDIATRIC HOSPITAL • SOCIAL HEALTH CLINIC
H I V - N A T ANNUAL REPORT 2 0 1 2 5 INTerNATIoNAL AdVISorY BoArd 2012
1 Mr. Phan Wannamethee (Chairman) Secretary General Te Tai Red Cross Society, Bangkok, Tailand
2 Dr. ej Bunnag Assistant Secretary General Te Tai Red Cross Society, Bangkok, Tailand
3 Prof. Emeritus Praphan Phanuphak Director o Te Tai Red Cross AIDS Research Centre, Tai Red Cross Society, Bangkok, Tailand
4 Prof. David A Cooper Director o Te Kirby Institute or inection and immunity in society (ormerly known as the National Centre in HIV Epidemiology and Clinical Research); Te University o New South Wale Sydney, Australia
5 Prof. Sean Emery National Centre in HIV Epidemiology and Clinical Research Te University o New South Wale Sydney, Australia
6 Prof. Joep M A Lange Proessor o Medicine, Center or Poverty-related Communicable Diseases Academic Medical Center, University o Amsterdam Executive Scientifc Director, Amsterdam Institute or Global Health & Development Co-director HIV-NA
7 Prof. Martin Grobusch Proessor o Medicine Dep. o Inectious Diseases, ropical Medicine and HIV/AIDS AMC (Academic Medisch Centrum) o the University o Amsterdam, Amsterdam
8 Assoc. Prof. Sophon Napathorn Dean, Faculty o Medicine, Chulalongkorn University Bangkok, Tailand
9 Prof. Ploenchan Chetchotsakd Faculty o Medicine, Khonkaen University, Khonkaen, Tailand
10 Dr. imothy Holtz Director, HIV/SD Research Program Tailand MOPH-US CDC Collaboration, Ministry o Public Health, Nonthaburi, Tailand
11 Dr. Annette Sohn amAR Vice President o Global Initiatives and Director, REA Asia Bangkok, Tailand
12 Dr. Viseth Ngauy Chie, Chie o the Department o Retrovirology, AFRIMS USAMC-AFRIMS Bangkok, Tailand
13 Prof. Tira Sirisanthana Proessor o Medicine, Faculty o Medicine, Chiang Mai University Former Director, Te Research Institute or Health Sciences (RIHES)
6 H I V - N A T ANNUAL REPORT 2 0 1 2 CoLLABorATorS
INERNAIONAL COLLABORAORS
AUSRALIA HE NEHERLANDS Te Kirby Institute for Infection and Immunity Amsterdam Institute for Global Health and in Society, formerly known as the National Centre Development (AIGHD) and University of in HIV Epidemiology and Clinical Research, Amsterdam University of New South Wales, Sydney Joep M.A. Lange (HIV-NA co-director), Ferdinand Wit, David A. Cooper (HIV-NA co-director), Sean Emery, Peter Reiss, Remko van Leeuwen, Janneke van de Sarah Pett, Cate Carey, Mark Boyd, Rebekah Puls, Wijgert, Jacqueline van ongeren, Martin Grobusch, Carlo Dazo, David Courtney-Rodgers, Natalie Espinosa, Frank van Leth, and Mark van der Valk Jessica aylor, Alli Humphries, Courtney Bendall, Gail Matthews, Greg Dore, Pip Marks, Amanda Erratt, Radboud University, Nijmegen Medical Center Megan Evans, Leanne Kearney, Nisha Seneviratne, (Clinical Pharmacology) Mee Ling Munier, Anthony Kelleher, Hila Haskelberg, David Burger Maria Arriaga, Christoph Boesecke, Matthew Law, Di Carey, Anna Donaldson, Kymme Courtney-Vega, and Maja Berilazic SINGAPORE National Healthcare Group Pte Ltd Monash University, Melbourne Infectious Lawrence Lee Soon-U Diseases Unit, Te Alfred Hospital, Melbourne Sharon Lewin, Jennier Audsley and Megan Crane SWIZERLAND Geneva University Medical School, Geneva Victorian Infectious Diseases Service, University Hospital Royal Melbourne Hospital, Melbourne Bernard Hirschel and Alexandra Calmy Joe Sasadeusz and Stephen Locarnini
Victorian Infectious Diseases Reference HE UNIED SAES OF AMERICA (USA) Laboratory, Victorian Infectious Diseases Service, Lab of Neuro Imaging University of California Royal Melbourne Hospital, Melbourne Los Angeles, School of Medicine, Los Angeles Scott Bowden Paul Tompson
Royal Perth Hospital Johns Hopkins Center for Global Health, Martyn French Division of Infectious Disease, Baltimore Chloe Tio CAMBODIA Memory and Aging Center at University of Family Health International Laurent Ferradini California, San Francisco Victor Valcour National Center for HIV/AIDS, Dermatology and University of Missouri Behavioral Neuroscience/ SDs (NCHADS) Neuropsychology, St. Louis, Missouri Mean Chhi Vun and Sarah Human Robert Paul National Pediatric Hospital, Phnom Penh Vonthanak Saphonn University of Hawaii, Manoa, Hawaii Cecilia Shikuma
JAPAN Wayne State University, Detroit Research Institute of uberculosis, Japan Anti- Chokechai Rongkavilit uberculosis Association, okyo, Japan Hideki Yanai and Norio Yamada Vanderbilt Institute for Global Health, Nashville, ennessee Vikrant Sahasrabuddhe INDONESIA Sanglah Hospital and Faculty of Medicine, Anal Neoplasia Clinic, University of California, Udayana University, Denpasar, Bali, Indonesia San Francisco uti Parwati Joel Palesky
Cipto Mangunkusumo Hospital, Jakarta, Indonesia Evy Yunihastuti
H I V - N A T ANNUAL REPORT 2 0 1 2 7 DOMESIC COLLABORAORS
BANGKOK We Understand Group AIDS, B and SIs Control Division Bangkok Chutima Saisaengjan and Nicha Leehacharoenkul Metropolitan Administration, Bangkok, Tailand Piyathida Smutraprapoot Children and Youth program SEARCH Sudrak Lakhonpon, Chutima Ketbumrung Faculty of Medicine, Vajira Hospital, University of and Sangla Najai Bangkok Metropolitan Administration, Tailand Warangkana Munsakul CHANABURI Prapokklao Hospital Chulalongkorn Hospital Chaiwat Ngampiyasakul Chitsanu Panchareon, Gompol Suwanpimolkul, Opass Pucharoen, Pisith angkitvanich, Piyawat Komolmit, Rungsun Rerknimitr, CHIANG MAI Sukalaya Lerdlum, Surasith Chaithongwongwatthana, Research Institute for Health Sciences (RIHES), Vorasuk Shotelersuk, Wattanee aweesith, Chiang Mai University Yingyos Avihingsanon, Leilani Paitoonpong, Virat Sirisanthana and Khuanchai Supparatpinyo Voraphoj Nilaratanakul, Nontalee Tongsong, ornvimol Leethong, Paisan echawaleekul, Suwimon Khusuwan, Kamol Kawkitinarong, Nakornping Hospital Suparat Kanjanavanit Kamolwan Jutivorakool, Kearkiat Praditpornnsilpa, awathai Chawatanarat, Surang riratanachart, Somboon Keelawat, Somchai Niruthisard, Program for HIV Prevention and reatment Lalana Sansopa, and Patoo anpairoj Jerey Parsons, Marc Lallemant, Sylvie Naar-King, Gonzague Jourdain and Nicole Ngo-Giang-Huong Faculty of Psychology, Chulalongkorn University Arunya uicomepee Sanpatong Hospital Virat Klinbuayaem Phramongkutklao Hospital of the Royal Tai Army Pichai Saengcharnchai and Pongrak Boonyanurak CHIANG RAI Chiangrai Prachanukroh Hospital, Queen Sirikit National Institute of Child Health Chiangrai, Tailand awee Chotpitayasunondh and Piyarat Suntarattiwong Pacharee Kantipong, Pisanu Kantipong and Rawiwan Hansudewechakul Rajvithee Hospital Pairaj Kateruttanakul, avatchai Jariyasethpong Mea Chan Hospital, Chiang Rai and Pairaj Kateruttanakul Sudanee Buranabenjasthen and Suvimon Yama
Ramathibodi Hospital Phan Hospital, Chiang Rai Sasisopin Kiertiburanakul, Somnuek Sungkanuparph, Noprada Panyayeun and Ploy Chaisawad Suwat Benjaponpitak and Chonamet echasaensiri Mae Suai Hospital, Chiang Rai Siriraj Hospital Atsanai Kittipanyaworakun and Picheth Kanphakrue Kulkanya Chokephaibulkit, Surapol Suwanagool, Wichai echasathit, Winai Ratanasuwan, Mae Sai Hospital, Chiang Rai Tanomsak Anekthananon Jariyarat Nitipatkosum and Suratsawadee Sitiyos aksin Hospital Phaya Meng Rai Hospital, Chiang Rai Supunnee Jirajariyavej Ampawan Srikruttranun and Preyarat Netsuwan Te Tai Red Cross AIDS Research Centre Somdej Phra Yanna Sangworn Hospital, Mana Khongpatanayothin, Nittaya Phanuphak, Nipat eeratakulpisarn, Somsong eeratakulpisarn, Chiang Rai Jureeporn Jantarapakde, and Pailin Suvanmala awatchai Jaikamwang and Malai Jaisuda
UNICEF Tailand Robert Gass and Nonglak Boonyabuddhi
8 H I V - N A T ANNUAL REPORT 2 0 1 2 Toeng Hospital, Chiang Rai PECHABURI Suthida Liengchawengwong and Jirattikarn Sukying Petchaburi Hospital Witaya Petdachai AIDS ACCESS Foundation, Chiang Rai Namphung Plangruan and Songsopa Wongsa PHISANULOK Research Institute of uberculosis, Buddhachinaraj Hospital Japan Anti-uberculosis Association Narong Lertpienthum Maitri Oongern, Saiyud Moolphate, and Tittaya Kulprayong SURIN Surin Hospital CHONBURI Pakarat Sangkla Chonburi Hospital Chureeratana Bowonwattanuwong SURAHANEE Suratthanee Hospital Queen Savang Vadhana Memorial Hospital Songsak Serirodom Wicharn Luesomboon, anate Jadwattanakul UBON RACHAHANI KHON KAEN Sappasitthiprasong Hospital Srinagarind Hospital, Khon Kaen University, Pramot Srisamang Khon Kaen, Tailand Ploenchan Chetchotisakd, Pagakrong Lumbiganon, Siriluck Anunnatsiri, Pope Kosalaraksa UDONHANI and Piroon Mootsikapun Udonthani Hospital Wanida Chatchomchuan Khon Kaen Hospital, Khon Kaen, Tailand Niramon Leeratanapetch, Pornrith Sutthiman and Wattanachai Susaengrat
NONHABURI Bamrasnaradura Infectious Disease Institute, Nonthaburi, Tailand Jurai Wongsawat, Weerawat Manosuthi and Wisit Prasithsirikul
Central Chest Hospital Charoen Chuchottaworn
Department of Disease Control, Ministry of Public Health, Nonthaburi, Tailand Somsak Akkasilp, Petsi Sirinirund, and Cheewanan Lertpiriyasuwat
Division of HIV/AIDS Prevention, Tailand Ministry of Public Health – US Centers for Disease Control and Prevention Collaboration, Ministry of Public Health, Nonthaburi, Tailand Frits van Griensven, imothy H. Holtz, Supaporn Chaikummao
National Health Security Ofce (NHSO) Sorakij Bhakeecheep and Winai Sawasdivorn
Please note that this list is not exclusive nor exhaustive. Since new research studies are developed and existing studies change, it is possible that some collaborators may not be listed.
H I V - N A T ANNUAL REPORT 2 0 1 2 9 OVERVIEW OF HIV-NAT STUDIES
In 2012, HIV-NAT conducted a total of 72 studies, 44 of which were conducted on adults and 28 on children/adolescents. There are 6 pharmacokinetic studies of which 3 are done in children and 2 in adolescents. There are 13 co-viral and viral studies: 4 hepatitis, 4 human papilloma virus (HPV), 4 influenza, and 1 cytomegalovirus (CMV) studies of which 2 has been completed (HPV and CMV studies). There are three Tuberculosis (TB) studies, 9 cohort studies and 5 strategic studies with 14 additional substudies. For the first time this year, we have added a new section of studies to accommodate the increase in sexual health studies. There are four sexual health studies and one substudy. Two more sexual health studies were awaiting IRB approval at time when this report was sent to press (December 2012). There are 22 pediatric studies and more on the way. Overall, there are 11 ongoing and 11 completed studies. At the time of writing this, there were 6 studies pending IRB approval (3 pediatric studies, 1 hepatitis study, 1 pharma- cokinetic study and 1 TB study). Five studies are awaiting funding approval (3 pediatric studies, 1 HCV study and 1 elite controllers).
is year, HIV-NAT has undergone some major internal changes but exciting changes. e Clinical Research Associates (CRAs) now handles all IRB preparations, submissions and follow-ups. e medical team has two staff to help with it so more work can be completed in a timely manner: medical coordinator and grant manager. Some of the nurses have under- gone training to become nurse practioners to help see adult cohort patients.
10 H I V- N AT ANNUAL REPORT 2 0 1 2 Our biostatisticians, CRAs, lab and nurses In addition, this year we are seeing an participate in presenting the latest articles in increase number of studies being conducted English at journal club with the MDs. Our nurses in the adolescent population as many of our also present interesting or problematic cases in pediatric patients are starting to become our Clinical Case Discussion sessions held teenagers and encountering a different set of monthly. ey are undergoing additional training problems. Even within the adolescent population, so they can write up study protocols to conduct there are distinct differences between the their own studies as well as manuscripts. perinatally HIV-infected adolescents versus the behaviorally HIV-infected youths. A new category of studies has been added this year due to an increased number of sexual health ere are so many unanswered questions, studies by our obstetrician. Many of our clinical especially in the field of HIV which is always trial research nurses have shown enthusiastic changing at a rapid pace. HIV-NAT has dedicated interest in this field. As Ms. Chuleeporn Wong- itself to continue to conduct quality research voranet stated, “e sexual and reproductive by addressing those issues relevant and health (SRH) research for women living with HIV/ important to the country, region and worldwide. AIDS is fundamental to their well-being and that It is diffi cult to keep abreast of all the new of their partners and children. Improving women’s developments but our dedicated staff and sexual and reproductive health, HIV treatment collaboration with various organizations and and HIV prevention among couples are important institutions have made this possible. HIV-NAT factors. HIV-NAT has conducted several sexual would like to acknowledge all of its contri- and reproductive health (SRH) research studies butors for their unwavering support. so we can better understand sexual life and reproductive health to provide a new standard of reproductive health service to HIV-infected women and their partners.”
Ms. Parawee ongpaeng added, “Sexual health is a state of physical, mental and social well-being in relation to sexuality. According to WHO’s definition, it requires a positive and respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence. We cannot ignore sexual health because the burden of morbidity has increased due to misperception. is is unacceptably high, especially in a field that is preventable if we have the correct medical knowledge. Sexual health is part of the human development just as men or women are essential for economic and social stability and progress in all societies. Providing health care by the medical team should not only focus on the inequality of knowledge but also from cultural and economic differences. at’s why I am interested in sexual health.”
H I V- N AT ANNUAL REPORT 2 0 1 2 11 NUMBER OF STUDIES IN 2011 vs 2012
35 PK
30 viral coinf TB 25 Cohort
20 Stragety New Drug 15 Sex
10 Oth
Ped 5
0 2011 2012
Please note that this year, each substudy KEY TO ABBREVIATIONS is not counted as a study. Instead, the PK Pharmacokinetics Studies main study is counted. For example, the Viral coinf. Clinical Research Programs in Co-Viral and Viral Infections START study (Strategic study) has 10 TB Clinical Research Programs in HIV/TB Co-Infections substudies but is counted as only 1 study. Cohort Long Term Cohort Analysis Strategy Strategy Studies In addition, this year we have fewer large New Drug New Drug Development studies but more substudies. EAP Expanded Access Programs Sex Sexual Health Studies Oth Others Ped. Pediatric and Youth Research Programs
14 completed
ongoing 12 just started
10
8
6
4
2
0 PK Viral coinf TB Cohort Strategy New Drug Oth Sex Ped
12 H I V- N AT ANNUAL REPORT 2 0 1 2 OVERALL THAI SUPPORT
Government agencies number of studies Commission of Higher Education, Ministry of Education (CHE) 2 Ministry of Public Health (MOPH) 2 National Health Security Office (NHSO) 4 National Research Council of ailand 4 Social Security Offi ce (SSO) 1 ai Research Fund 1 National Research University (NRU) 3 Department of Disease Control (DDC) 2
Pharmaceutical partner Government Pharmaceutical Organization 2
Academic organization Chulalongkorn University 12
Funding agency e Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: ACHIEVED Project (Global fund ailand) 2
Research organizations HIV-NAT 5 ai Red Cross AIDS Research Centre 4
OVERALL INTERNATIONAL SUPPORT
Governmental agency number of studies National Institute of Health (NIH) 8
Pharmaceutical partners Abbott 1 Bristol-Myers Squibb 4 Gilead Sciences 3 Matrix 1 Merck & Co., Inc 1 ROCHE Pharmaceutical 1 Tibotec Pharmaceuticals 6 ViiV 1 Glaxo Smith Kline 1
Academic organizations Foundation for AIDS Research, United States (amfAR)/TREAT Asia 12 e Kirby Institute for Infection and Immunity in Society, Sydney, Australia 6
Research organization Pediatric European Network for Treatment of AIDS (PENTA) 3
Funding agency UNICEF 1
Charity Art AIDS Fund 1
Please note that this list is not exclusive nor exhaustive. Since new research studies are developed and existing studies change, it is possible that some collaborators may not be listed.
H I V- N AT ANNUAL REPORT 2 0 1 2 13 PHARMACOKINETIC STUDIES
There are 6 pharmacokinetic studies, 3 of which are done in children and 2 in adolescents. All of the pediatric pharmacokinetic (PK) studies are ongoing. One adult pharmacokinetic study was completed in 2012. The manuscript for this study was drafted at the time this annual report was published (December 2012).
“HIV-NAT is a pioneer in studying PK of Status: Closed May 8, 2012 antiretrovirals in ai patients. HIV-NAT’s studies Site: Khon Kaen University have shed light on the uniqueness in PK and Funding: Ratchadaphiseksomphot Fund, Faculty pharmacogenomic profile of Asians. HIV-NAT of Medicine, Chulalongkorn University studies have consistently shown that ais have Results: ai children achieved similar TDF high NNRTI and PI drug concentrations compared exposures to Western children and adults. Renal to those reported in Caucasians. is has led to toxicity was uncommon but continued monitoring changes in the ai national guideline to use lower is required to ascertain long-term effects. than manufacturerrecommended dosages for several antiretroviral drugs. Using low dose TDF PK in adolscents antiretrovirals could lead to reduce side effects HIV-NAT 145 and cost; an important consideration for e objective of this study is to describe the PK resource-limited settings such as ailand.“ parameters of TDF when administered with PIs in – Sasiwimol Ubolyam HIV-infected Asian adolescent aged 12-<18 years Status: Opened on Oct. 6, 2011. Ongoing erapeutic Drug Monitoring (TDM) Studies Target/Enrolled: 20/20 HIV-NAT 118 Sites: HIVNAT erapeutic Drug Monitoring of the generic Funding: e American Foundation for AIDS tenofovir/lamivudine/efavirenz tablets in the Research (amfAR), erapeutics Research, ai HIV-infected Patient Education, and AIDS Training in Asia (Treat Asia) is is a prospective, open-label, single arm study that assesses the effi cacy and safety of fixed TDF PK in adolscents dose combination of TDF/3TC/EFV. HIV-NAT 145.1 Target/Enrolled: 100/100 e objective of this study is to describe mid-dose Status: Opened on February 2, 2010. Completed concentration of TDF in children aged 8 - <18 Funding: Matrix Laboratory years using TDF in various dosages Results: e generic FDC of TDF/3TC/EFV was Status: Opened on June 2012. Ongoing well tolerated and effi cacious. Our findings lend Target/Enrolled: 50/20 support to the use of this generic FDC as first-line Sites: 2 sites ailand and Vietnam antiretroviral therapy in resource limited settings. Funding: amfAR, Treat Asia Presentation: Maekanantawat W, Avihingsanon A, ainsanguankul W, Wongsabut J, Gorowara M, HIV-NAT 146 Ramautarsing R, Clarke A, Hsu D, Ruxrungtham K. e study of atazavanir/ritonavir-based HAART Safety and effi cacy of once daily single generic in ai HIV-infected children fixed drug combination tablet of tenofovir, is trial will study the pharmacokinetics lamivudine and efavirenz among HIV infected of atazanavir/ritonavir (ATV/r) in HIV-1 infected ais. [Poster # P312] was presented at the ai children. International Congress on Drug erapy in HIV. Status: Opened on July 14, 2011. Ongoing Glasgow, Glasgow, UK. 11-15 November 2012 Target/Enrolled: 20/20 Collaborators: amfAR, Treat Asia, NHSO for HIV-NAT 131 antiretrovirals and certain laboratory testing, and Pharmacokinetics Study of Tenofovir in GPO for ritonavir tablet 100 mg, Department of HIV-infected ai Children using Tenofovir-based Pediatrics, Ramathibodi Hospital, Mahidol Regimen University is study will assess the pharmacokinetics of Funding: amfAR, Treat Asia, NHSO, and GPO Tenofovir in HIV-infected ai children using Tenofovir-based regimen. Target/Enrolled: 32/32
14 H I V- N AT ANNUAL REPORT 2 0 1 2 Presentation: Bunupuradah T, Techasaensiri C, Keadpudsa S, ammajaruk N, Srimuan A, Sahakijpicharn T, Prasitsuebsai W, Ananworanich J, Puthanakit T. on behalf of the HIV-NAT 146 study team. Pharmacokinetics of atazanavir/ritonavir among ai HIV-infected children concomitantly taking tenofovir disoproxil fumarate. Oral presentation A-477-0009-00205 will be presented at the 6th Asian Congress of Pediatric Infectious Diseases (ACPID 2012). BMICH, Colombo, Sri Lanka. 28 Nov – 1 Dec 2012
HIV-NAT 167 Pharmacokinetics of Abacavir once daily vs. twice daily in HIV-infected ai Children is study will evaluate pharmacokinetic of abacavir in ai HIV-infected children. Status: Open Feb 23, 2012 Target/Enrolled: 30/30 Collaborator: PHPT Funding: amfAR, Treat Asia
CLINICAL RESEARCH PROGRAMS IN CO-VIRAL AND VIRAL INFECTIONS
There are 13 co-viral and viral studies. There are 4 hepatitis, 4 human papilloma virus (HPV), 4 influenza, and 1 cytomegalovirus (CMV) studies of which 2 has been completed (HPV and CMV studies). From the 4 hepatitis studies, 2 are cohort studies for HBV and 1 is an HCV study. Our hepatitis cohort is one of the largest in the world. Other coinfections studies are currently in the pipeline awaiting for funding and/or IRB approval.
Hepatitis co-infection, both HBV and HCV, HIV-NAT 098 continues to be one of the leading causes of is is a prospective, observational study in death among HIV infected patients worldwide a multi-centre, international cohort surveillance despite having available and adequate treatment study for the detection of hepatitis B virus (HBV) for HBV whereas for HCV, treatment continues to resistance to tenofovir (TDF) in HIV-HBV remain elusive. Furthermore, hepatitis co-infection co-infected patients with HIV accelerates the disease progression. Status: Opened on Oct 9, 2008. Ongoing. Because of this, HIV patients are also screened Target/Enrolled: 52/52. Worldwide there is a for hepatitis and vice versa. Monitoring disease total of 93 cases progression by noninvasive technique such as Collaborators: Sharon Lewin, Joe Sasadeusz, fibroscan has shown high promise and is currently Jennifer Audsley and Gail Matthews being used in several of our hepatitis/fibrosis Sites: Australia: e Alfred Hospital, Melbourne, studies and substudies. On the other hand, with Melbourne Sexual health Centre (MSHC), an increase in cervical and anal cancer among Melbourne and St Vincent’s Hospital, Sydney. HIV-infected patients, more attention is now also ailand: ai Red Cross AIDS Research Centre given to HPV. As a result of this, both HIV-infected and Department of Medicine, King Chulalongkorn men and women are recommended to have anal Memorial Hospital, Bangkok pap smear and pap smears once per year regard- Funding: Gilead Science less whether the previous result was normal. In ailand, the TRC-ARC is the only place that offers this new screening tool anal pap smear.
H I V- N AT ANNUAL REPORT 2 0 1 2 15 Long-term HBV cohort Publication: Surveillance of illness associated HIV-NAT 105 with pandemic (H1N1) 2009 virus infection among Long term outcome of HBV in ai cohort adults using a global clinical site network approach: of HIV/HBV co-infected patients (Substudy e INSIGHT FLU 002 and FLU 003 studies. of HIV-NAT 006) Vaccine 2011. 29S: B56-B62. is is a long term cohort to assess HBV and HIV treatment outcome, liver fibrosis, renal function, FLU 003 metabolic syndrome, including vitamin D and Bone HIV-NAT 123 health. An International Observational Study to Status: Opened on Dec 25, 2008. Ongoing. Characterize Participants with Influenza A- Target/Enrolled: 155/155 Pandemic H1N (H1N1v) Who Are Hospitalized Funding: ai Research Fund with Complications of Influenza. INSIGHT H1N1v Influenza Hospitalization Study. HBsAg e purpose of this observational study is to HIV-NAT 105.1 describe the characteristics and outcomes over Hepatitis B surface antigen levels in long term a 60-day follow-up period of participants in therapy of tenofovir in HIV-HBV-coinfected geographically diverse locations who develop patients influenza A -pandemic H1N1 (H1N1v) and who is is a cross section study to evaluate the role are hospitalized with complications resulting of quantitative HBsAg in predicting treatment from influenza. response to HBV. Status: Opened Jan. 21, 2010. Ongoing Status: Opened on 4 May 2012 Target/Enrolled: unlimited/15 enrolled cases as Target/Enrolled: 150/150 of Sep-2012 for Chulalongkorn site; 5 enrolled Collaborators: Department of Biochemistry, Fac- cases for Khon kaen site ulty of Medicine, Chulalongkorn University Collaborators: Division of Infectious Diseases, Funding: Ratchadaphiseksomphot Fund, Faculty of Department of Medicine,University: Opass Medicine, Chulalongkorn University Putcharoen, Sarawoot Marklon, Leilani Paitoon- pong, Gompol Suwanpimolkul, Voraphoj Nilarata- FLU002 nakul, Nontalee ongsong, Pornvimol Leethong, HIV-NAT 122 Paisan Techawaleekul, Suwimon Khusuwan; Khon An International Observational Study to Kaen University: Ploenchan Chetchotsakd Characterize Adults with Influenza A –Pandemic Enrollment (projected): 1,000 patients in Asia, H1N1 (H1N1v) Europe, Australia, North and South America INSIGHT H1N1v Outpatient Study (FLU 002) Sites: Chulalongkorn Hospital, Srinakarind Hospital e purpose of this observational study is to and Khon Kaen University. describe participants in geographically diverse Funding: National Institute of Allergy and locations with influenza A-pandemic H1N1 (H1N1v) Infectious Diseases (NIAID), National Institutes of virus infection and their clinical course over a Health (NIH) and carried out by the International 14-day period following enrolment. Network for Strategic Initiatives in Global HIV Status: Opened Jan. 21, 2010. Ongoing Trials (INSIGHT). Target/Enrolled: unlimited/213 enrolled cases as of 2-Oct-2012 for Chulalongkorn site; 96 enrolled HCV cases as of 2-Oct-2012 for Khon kaen site HIV-NAT 125 Collaborators: Division of Infectious Diseases, Characteristics and clinical significances of Department of Medicine, University: Opass Put- hepatitis C genotype in HIV-and hepatitis C charoen, Sarawoot Marklon, Leilani Paitoonpong, co-infected ai patients. Gompol Suwanpimolkul, Voraphoj Nilaratanakul, Status: Opened June 8, 2010. Ongoing Nontalee ongsong, Pornvimol Leethong, Paisan Target/Enrolled: 100/100 Techawaleekul, Suwimon Khusuwan; Khon Kaen Funding: Ratchadaphiseksomphot Fund, Faculty University: Ploenchan Chetchotsakd. of Medicine, Chulalongkorn University, and Office Enrollment (projected): 1,500 patients in Asia, of the National Research Council of ailand Europe, Australia, North and South America Results: HCV genotype 3 (47%) is predominant Sites: Chulalongkorn Hospital and Srinakarind circulating HCV genotypes in our HIV/HCV Hospital/Khon Kaen University co-infection and HCV mono infection, following by Funding: National Institute of Allergy and genotype1 (34%) and genotype 6 (18%). High Infectious Diseases (NIAID), National Institutes of prevalence of HCV genotype 6 was observed (13% Health (NIH) and carried out by the International HIV/HCV and 18% HCV mono). HCV genotype 6 Network for Strategic Initiatives in Global HIV tended to have higher HCV RNA but lesser liver Trials (INSIGHT). fibrosis compared to HCV genotype 1 and 3.
16 H I V- N AT ANNUAL REPORT 2 0 1 2 Approximately, 91% of our patients have HPV study favorable IL-28B gene. Factors associated with Prevalence and 6- and 12-month incidence of moderate to severe liver fibrosis in our HCV cervical cytological abnormality and HR-HPV patients were HIV-coinfection, HCV genotype infection in a cohort of HAART naïve and HAART 3 and Fib-4 >1.45 experienced women. Presentation: Avihingsanon A, Mek-A-nantawat Status: Completed 2012 W, Apornpong T, Akkarathamrongsin S, Ubolyam S, Site: e ai Red Cross AIDS Research Center Chomhong P, Tangkitvanich P. Distribution of HCV (TRC-ARC) genotype and Single Nucleotide Polymorphisms Collaborators: SEARCH, e ai Red Cross AIDS (SNPs) of IL-28B gene in HIV/HCV coinfected Research Center (TRC-ARC), Vanderbilt University ai Populations. [Poster # P132] presented at and Amsterdam Institute for Global Health and the International Congress on Drug erapy in HIV. Development (AIGHD) Glasgow, Glasgow, UK. 11-15 November 2012 Funding: Commission of Higher Education, National Research University, HIV-NAT CMV study Presentation: Ramautarsing RA, Phanuphak N, HIV-NAT 130 Ananworanich J, Sahasrabuddhe V, Lange JMA, Mortality and Morbidity Risk Factors of Wit F, van de Wijgert JH, Pankam T, Rodbamrung Cytomegalovirus Viremia in AIDS Patients Starting P, Phanuphak P, Triratanachat S, Teeratakulpisarn Antiretroviral erapy in ailand N, Chaithongwongwatthana S. Anogenital is is a retrospective observational cohort and HPV-infection in ai HIV-infected women with nested case-control study. is study will assess high CD4 counts [Poster P32.33] presented at the possible association between CMV viremia the 27th International Papillomavirus Conference. and increased risk of mortality or the development September 17-22, 2011, Berlin, Germany of AIDS-defining illnesses in patients from Results: Manuscript for baseline results has HIV-NAT 006 long term cohort. been submitted. Results from 12 months are Status: Closed 2012 currently being analyzed. Target/Enrolled: 600/336 Published: Manuscript has been submitted. Funding: Abbott
H I V- N AT ANNUAL REPORT 2 0 1 2 17 HPV-019 PRI Status: Opened June 26, 2012. Ongoing. HIV-NAT 161 Target/Enrolled: 720 globally; 10 per ai site/5 A phase IV, observer-blind, randomized, enrolled patients at Bamrasnadura Infectious controlled, multicentric study to assess the Disease Institute site only. safety and immunogenicity of GSK Biologicals’ Sites: 4 sites in ailand; 48 sites worldwide HPV-16/18 L1 VLP AS04 vaccine ( Cervarix ) Collaborators: National Institute of Health (NIH), administered intramuscularly according to a Bamrasnaradura Infectious Disease Institute, Khon three-dose schedule (Day 0, Week 6, Month 6) in Kaen University, Siriraj Hospital, and the Division human immunodeficiency virus-infected (HIV+) of Infectious Diseases, Department of Medicine, female subjects aged 15 – 25 years, as compared Faculty of Medicine, Chulalongkorn University to Merck’s HPV-6/11/16/18 vaccine ( Gardasil )).” Funding: National Institute of Health (NIH) Status: Opened on June 7, 2011 Target/Enrolled: 30/30 IRC 004/HIV-NAT 165 Funding: GlaxoSmithKline A Randomized Double-Blind Study Comparing Standard Treatment Versus HIV-NAT 163 Placebo for the Treatment of Influenza in HPV genotypes present in cervical dysplasia Low Risk Adults and cervical cancer in HIV-infected women is is a randomized blinded study that will e aim of this study is to investigate the HPV- evaluate whether the standard treatment genotype distribution in HIV-infected women with modifies viral shedding in an ambulatory popu- cervical cysplasia or cervical cancer compared to lation with uncomplicated influenza and explore HIV-uninfected women. Stored tissue samples the relationship between virologic effects and from Chulalongkorn Hospital are used for HPV clinical effects, effects on proinflammatory genotyping. mediators, and to start understanding if Status: Opened on July 26, 2011. Ongoing improve ments to virologic shedding correlate Target 100 with improvements in clinical outcomes. Collaborators: ai Red Cross AIDS Research Status: Opened June 26, 2012. Ongoing. Center (TRC-ARC), Chulalongkorn University Target/Enrolled: 560 globally; 50 per ai Funding: Ratchadaphiseksomphot Fund, Faculty site/1 enrolled case at Chulalongkorn Hospital of Medicine, Chulalongkorn University and 20 enrolled cases at Bamrasnaradura Infectious Disease Institute IRC 003/HIV-NAT 164 Sites: 4 sites in ailand; 48 sites worldwide A Randomized Double-Blind Phase 2 Study Collaborators: National Institute of Health (NIH), Comparing the Effi cacy, Safety, and Tolerability Bamrasnaradura Infectious Disease Institute, of Combination Antivirals Versus Standard Khon Kaen University, Siriraj Hospital and the Treatment for the Treatment of Influenza in Division of Infectious Diseases, Department of Adults at Risk for Complications Medicine, Faculty of Medicine, Chulalongkorn is is a multicentered, randomized double-blind University phase 2 study that will assess the effi cacy, safety, Funding: National Institute of Health (NIH) and tolerability of combination antivirals versus the standard treatment for the treatment of HPV Vaccine influenza in an at-risk outpatient population. HIV-NAT 177 Evaluation of immunogenicity and safety of the bivalent HPV vaccine in HIV-infected women Status: Recruitment is open Target: 150 women Collaborators: ai Red Cross AIDS Research Center (TRC-ARC), Chulalongkorn University Site: ai Red Cross AIDS Research Center (TRC-ARC) Funding: Ratchadaphiseksomphot Fund, Faculty of Medicine, Chulalongkorn University
18 H I V- N AT ANNUAL REPORT 2 0 1 2 CLINICAL RESEARCH PROGRAMS IN CO-TUBERCULOSIS INFECTIONS
There are three Tuberculosis (TB) studies currently being conducted in adults of which one still needs additional funding. HIV-NAT is currently participating in the TB network. TB studies emerging from the network address issues pertaining to the country with the aim to improve the TB care in the country so that we can reduce TB mortalities by half by 2015 as per the Millenium Development Goals. Working with various Chest Units from the different hospitals have been fruitful in accomplishing this goal.
Optimize TB Treatment outcome in Tertiary Care Hospitals Status: Opened on April 28, 2011. Ongoing Target/Enrolled: 936/336 Site PIs: Bamrasnaradura Infectious Disease Institute: Kamon Kawkitinarong Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University: Opass Puthacharoen Sites: Bamrasnaradura Infectious Disease Institute, Rajvethi Hospital, Chulalongkorn University (Chest Unit, Internal Medicine Department, and Division of Infectious Diseases, Department of Medicine, Chulalongkorn University Hospital) “TB is a major global health problem, a leading Collaborators: Disease Department Control cause of death in HIV infected persons and (DDC), ailand the burden is especially high in Asia and Africa. Funding: National Research University Grant (NRU) Successful TB control involves early case detection and diagnosis through quality-assured metho- Regional TB Study dology, provision of safe and effi cacious treatment HIV-NAT 170 and a system that support quality patient care Socio-Economic Determinants of Tuberculosis and supervision. e management of HIV and (TB), Multidrug-resistant TB, and Immune TB co-infection is further complicated by complex Reconstitution Syndrome in HIV-TB Co-infected interactions between drugs used to treat both Patients in Asia conditions. us HIV-NAT has conducted the Status: Opened April 5, 2012. Ongoing following studies.”– Denise Hsu Target/Enrolled: 400/4; 50 at HIV-NAT, 200 for all sites in ailand HIV-NAT 104 Funding: e American Foundation for AIDS is is a pilot study of the pharmacokinetics Research (amfAR), erapeutics Research, and safety of lopinavir/ritonavir 400/100mg bid Education, and AIDS Training in Asia (Treat Asia) versus lopinavir/ritonavir 600/150 mg BID combined with nucleoside analogue reverse transcriptase inhibitors in HIV/TB co-infected patients receiving rifampicin containing anti-tuberculosis therapy. Status: Opened on March 2, 2011. Ongoing Target/Enrolled: 17/40 Collaborators: David Burger (Radboud UMC Nijmegen, e Netherlands), Kamol Kawkitinarong and Gompol Suwanpimolkul (Infectious Disease, Chulalongkorn University) and Supannee Jirajariyavet (Infectious Disease, Taksin Hospital) Sites: TRC-ARC and Chulalongkorn Hospital Funding: HIV-NAT (additional funds being sought)
H I V- N AT ANNUAL REPORT 2 0 1 2 19 LONG TERM COHORT ANALYSIS
HIV-NAT has one adult long-term cohort (HIV-NAT 006) and pediatric long-term cohort (HIV-NAT 015) studies. From the PREDICT study, one of its substudy is a long-term cohort study (HIV-NAT 035.3; additional information is in the Pediatric section). HIV-NAT also participates in the region’s long-term cohorts for both the adults (TAHOD) and paediatrics (TApHOD). HIV-NAT also participates in the collection, maintenance and analysis of Thailand’s database of HIV infected patients (PROGRESS studies). There is one HPV co-infection cohort study (TNT HIV 003) done with the Thai Red Cross AIDS Research Centre. There are 2 hepatitis co-infection cohorts (additional information located in the Clinical Research Programs in Co-viral and Viral Infections section). In addition, hepatitis C co-infection cohort is being set up as we speak. There are two studies looking at the effects of syphilis and neurocognitive changes among patients from the 006 cohort. Other target population long-term cohorts are in the pipeline.
Long-term cohorts are necessary in order to see HIV-NAT 006 the long-term effects of either the drugs and/or is is a long-term, post study cohort of HIV- infection(s). Most of the studies do not look at infected patients who previously participated in long-term effects or over the span of 10 years HIV-NAT study protocols. Information collected and hence these cohorts will help elucidate some from this cohort will provide further insights into unanswered questions. Unfortunately the data the long-term safety and durability of various may be diffi cult to analyse and compare between antiretroviral therapeutic approaches, effi cacy of studied/analysed groups due to different initial HIV viral load and CD4 cell counts as predictors regimens or missing data for some of our older of disease progression, mortality, resistance patients. However, with time, additional information profiles, adherence, immune recovery syndrome, are collected as we find out which issues become opportunistic infections or malignancies, incidence important but the maintenance of such cohorts of lipodystrophy, other metabolic complications, are also expensive. HIV-NAT’s hepatitis co-infection cardiovascular, renal, hepatic, and endocrine cohort is one of the largest in the world and other function, skin, gastrointestinal system and types of cohorts targeting different populations urogenital tract problems and quality of life. are in the pipeline. Status: Opened May 15, 2007 Target/Enrolled: unlimited/1498
Collaborators: David A. Cooper and Joep MA Lange Funding: HIV-NAT Drug Fund, Division of AIDS Ministry of Public Health (MOPH) ailand, National Health Security Offi ce (NHSO), Social Security Offi ce (SSO), e Aligning Care and Prevention of HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project (Global fund ailand), Roche, Bristol-Myers Squibb, Merck & Co., Tibotec Pharmaceuticals Ltd., Gilead Science
20 H I V- N AT ANNUAL REPORT 2 0 1 2 Publications: Syphilis Study 1) Anal squamous intraepithelial lesions HIV-NAT 157 among HIV-positive and HIV-negative men who Serodiagnosis of syphilis and outcomes of have sex with men in ailand. Sex Transm treatment among HIV-infected patients Infect. 2009 Dec;85(7):503-7. is objective of this study is to determine the 2) Nadir CD4 count and monthly income predict prevalence of syphilis in the cohort HIV-NAT 006 cervical squamous cell abnormalities in HIV-positive study and the outcomes of treatment after 24 women in a resource-limited setting. Int J STD and 48 weeks using serological tests. AIDS. 2008 Aug;19(8):529-32 Status: Opened on Feb 17, 2011. Ongoing. 3) A prevalence of posttransplantation cancers Closed to recruitment. Awaiting analysis compared with cancers in people with human Enrolled: Phase 1: 1437 cases; Phase 2: 214 cases. immunodeficiency virus/acquired immunodeficiency Funding: Ratchadaphiseksomphot Fund, Faculty syndrome after highly active antiretroviral therapy. of Medicine, Chulalongkorn University, Transplant Proc. 2008 Oct;40(8):2677-9. Presentation: Maek-a-nantawat W, Jamthong J, 4) Assessing adherence in ai patients taking Laopraynak N, Moonthong K, Ubolyam S, HAART. Int J STD AIDS. 2012 Mar;23(3):160-5 Avihingsanon A. Syphilis and Risk behaviors among 5) Effi cacy and tolerability of zidovudine 200 mg HIV-infected individuals on antiretroviral therapy. BID as part of combination antiretroviral therapy Poster # 51.008 at the Society for Infectious for 96 weeks. J Acquir Immune Defic Syndr. Diseases, June 13-16, 2012, Bangkok 2010 Aug 15;54(5):e19-20. Results: e existence of latent syphilis continued 6) Cardiovascular Risk Assessment in Persons to be prevalent among HIV-infected patients in with HIV in the Developing World: Comparing our cohort.MSMs are at a higher risk of acquiring ree Risk Equations in a Cohort of HIV-infected syphilis and may require more-frequentscreenings ais. HIV Med. 2011 Sep;12(8):510-5. for STIs. To prevent STIs, physicians should 7) Feasibility and Effi cacy of INH prophylaxis encourage their patients to consistently for latent tuberculosis in HIV infected Patients in andregularly use condoms.Health education and ailand. AIDS Research and Human Retroviruses social marketing campaigns urgently need to 2012 Mar;28(3):270-5. target groupsat risk to consistently and regularly 8) Clarke A, Kerr S, Honeybrook A, Cooper DA, use condoms. Avihingsanon A, Duncombe C, Phanuphak P, Presentation: Maek-a-nantawat W, Jamthong J, Ruxrungtham K, Ananworanich J, Kaldor J. Laopraynak N, Moonthong K, Ubolyam S, Adherence and Risk Behaviour in Patients with Avihingsanon A. Syphilis and Risk behaviors among HIV Infection Receiving Antiretroviral erapy HIV-infected individuals on antiretroviral therapy. in Bangkok. e open virology journal. Poster # 51.008 presented at the 15th Open Virol J. 2012; 6:23-8. Inter-national Congress on Infectious Diseases 9) Praditpornsilpa K, Avihingsanon A, and the International Society for Infectious Chaiwata-narat T, Chaiyahong P, Wongsabut J, Diseases, June 13-16, 2012, Bangkok Ubolyam S, Chulakadabba A, Avihingsanon Y, Ruxrungtham K, Tunsanga K, Eiam-Ong S, HAND Study Phanuphak P. Comparisons between validated HIV-NAT 166 estimated glomerular filtration rate (GFR) Trial to evaluate neurocognitive functions, equations and isotopic GFR in HIV patients. neuropsychiatric changes and activities of daily AIDS. 2012 Sep 10;26(14):1781-8. living among HIV infected patients in the 10) Treatment outcome and safety of zidovudine/ Cohort HIV-NAT 006 study lamivudine/nevirapine fixed-dose combination is is an observational study among treatment in HIV-infected ai patients. (Submitted) naive or experienced HIV-infected adults who has 11) Long term effi cacy of Low Dose Ritonavir- been deferred, interrupted or initiated the first line Boosted Atazanavir (200/100 mg) in ai HIV-1 antiretroviral regimens and currently on antiretro- Infected Adults. (Submited) viral therapy using self assessed questionnaires Presentation: Prevalence and prognostic about neuropsychiatric changes and daily activities factors of chronic kidney disease in HIV-infected and brief assessment of neurological performance patients, HIV-NAT 006 cohort, ailand. with International HIV dementia scale (IHDS) [Poster #: 843] presented at the 18th and Montreal Cognitive Assessment (MoCA). Other Conference on Retrovirus and Opportunities tests such as Trial making, EIWA digit symbol task, Infections (CROI 2011). Boston, MA, USA. Grooved pegboard test and block design will also 27 February – 2 March 2011. be done. is study will describe the rates of neurocognitive changes among HIV-infected patients in the Cohort 006 study and determine factors related to neurocognitive changes among HIV-infected patients.
H I V- N AT ANNUAL REPORT 2 0 1 2 21 Status: Opened Nov 29, 2011. Ongoing is information will be used to develop more Target/Enrolled: HIV-NAT 006 cohort population/70 effective research and treatment programs for Collaborators: Pramongkutklao Hospital and people with HIV/AIDS in the region. SEARCH Status: Opened May 3, 2007. Ongoing. Funding: Seeking funding Target/Enrolled: 500/302 Funding: Foundation for AIDS Research, United HIV-NAT 015 States (amfAR) is is a long-term follow-up study of safety Publications and Presentations: (Please see and effi cacy of antiretroviral therapy for HIV Partnerships section for TApHOD) positive children who have previously participated in HIV-NAT study protocols. TNT-HIV 003 Status: Opened on July 8, 2003. Ongoing is is a five-year prospective cohort study Target/Enrolled: 500/332 that investigates the trends of morbidity and Collaborators: Chitsanu Panchareon, David A. mortality among ai HIV-infected and HIV- Cooper, Joep MA Lange uninfected patients. is study has one substudy, Site: Chulalongkorn Hospital TNT-HIV 003.1, which assesses the bone health Funding: e ai National Security Offi ce (NHSO) and vitamin D status in HIV-1 infected and and ai Ministry of Public Health, e Aligning uninfected adults. Care and Prevention of HIV/AIDS with Government Status: Started in Oct. 2010. Ongoing and open Decentralization to Achieve Coverage and Impact: to recruitment Project (Global fund ailand) Target/Enrolled: Group 1 (HIV infected):408/242; Publications: Group 2 (HIV uninfected):408/266 1) Pattern and predictors of immunologic recovery Site PIs: e ai Red Cross AIDS Research in human immunodeficiency virus-infected children Centre: Praphan Phanuphak receiving non-nucleoside reverse transcriptase Bamrasnaradura Infectious Disease Institute: inhibitor-based highly active antiretroviral therapy. Wisit Prasithisirikul Pediatr Infect Dis J. 2009 Jun;28(6):488-92. Queen Savang Vadhana Memorial Hospital: 2) Immunologic and virologic failure after first-line Tanate Jadwattanakul highly active antiretroviral therapy in HIV-infected Collaborators: Peter Reiss and Ferdinand Wit, children. AIDS Res er. 2011 Oct 26;8:40. Amsterdam Institute for Global Health and Development (AIGHD) TAHOD: e Treat Asia HIV Observational Funding: e ai Red Cross AIDS Research Database Centre and ViiV Healthcare ere is one substudy HIV-NAT 048 looking at vitamin D and bone health (TNT-HIV is study collects observational data on 003.1). is substudy is currently open to recruit- HIV-infected patients from a number of sites in ment and enrollment is ongoing. ere are three several Asian countries. e information gathered groups: 1. HIV infected, 2. HIV infected with HIV will help develop more effective research and CD4, and 3. HIV infected naives planning to treatment programs for people living with start HAART. HIV/AIDS in the region. Enrolled: Group1: 70; Group 2: 55; Group 3: 65. Status: Opened on January 15, 2008. Ongoing. Target/Enrolled: 200/200 e Progress (Adult cohort) Collaborators: Mana Khongpatanayothin and HIV-NAT 153 David A. Cooper e ai HIV Disease Progression: Collaborator/site: Chulalongkorn Hospital An Observational Database Coordinating Center: National Centre in HIV is is a multicenter, observational prospective Epidemiology and Clinical Research, University cohort study – open cohort that will study the HIV of New South Wales, Sydney, Australia disease progression in HIV-infected ai Adult. Funding: Foundation for AIDS Research, United Status: Opened on March 8, 2011. Ongoing States (amfAR) Target/Enrolled: 7000/5000 Publications and Presentations: Site PIs: Bamrasnaradura Infectious Disease (Please see Partnerships section for TAHOD) Institute: Wisit Prasithsirikul San Patong Hospital: Virat Klinbuayaem TREAT Asia Pediatric HIV Observational Sites: Bamrasnaradura Infectious Disease Database (TApHOD) Institute, San Patong Hospital and HIV-NAT HIV-NAT 080 Collaborators: Department Disease Control (DDC), is study is an HIV pediatric HIV observational ailand database collecting HIV clinical data from 6 Funding: Department Disease Control (DDC), countries located in the Asia-Pacific region. ailand
22 H I V- N AT ANNUAL REPORT 2 0 1 2 Pediatric Progress HIV-NAT 154 e ai Pediatric HIV Disease Progression: An Observational Database e objective of this cohort is to describe the multicenter cohort of HIV-infected children in ailand Status: Opened on March 8, 2011. Ongoing Target/Enrolled: 1,500 HIV-infected children from 4 sites/1139 Site: Chiangrai Prachanukroh Hospital, Sanpatong Hospital, Faculty of Medicine, Siriraj Hospital, Mahidol University Collaborators: Offi ce of the National Research Council of ailand, and Bamrasnaradura Infectious Diseases Institute, Nonthaburi Funding: Department Disease Control (DDC), ailand Presentations: Poster number 43.023 in 15th International Congress on Infectious Diseases (ICID), 13-16 June 2012, Bangkok, ailand
STRATEGY STUDIES
There are 5 strategic studies with 14 substudies, all of which are done with the Kirby Institute except for the feasibility study. One study looks at when is the optimal time to start ART based on CD4 count. Two studies look at reduced dosage versus standard dose. One study evaluates the use of second regimen amongst those patients who have developed drug resistant HIV strains whereas another study investigates the feasibility of the concept Test and Treat among the MSM population in Bangkok. Encore’s neurocognitive substudy was initiated by HIV-NAT.
Strategic studies aim to change the treatment deferral of ART until the CD4+ declines below guidelines by addressing research gaps or changing 350 cells/mm3 in terms of morbidity and how we currently care for the patients. ere are mortality in HIV-1infected persons who are several unanswered questions and research gaps antiretroviral naive with a CD4+ count above 500 especially in the developing countries such as cells/mm3. e study will proceed in two phases: aging in HIV infected population and management (1) a pilot phase, involving at least 900 partici- of noncommunicable diseases (i.e., cancer, renal, pants; and (2) a definitive phase, expanding pulmonary, neurocognitive and mental health). enrollment to an estimated 4,000 participants. We are slowly trying to address all of these Upon completion of the pilot phase, a recommen- questions as permitted by the available human dation will be made to the sponsor (DAIDS, NIAID, and financial resources. NIH) concerning whether the study should be expanded and prolonged into a definitive study. START (Strategic Timing of AntiRetroviral Successful completion of the pilot phase requires Treatment) enrollment of at least 900 participants in one year HIV–NAT 097 by 70 designated INSIGHT sites. For ailand, A Multicenter Study of the International Network seven additional sites were included: Siriraj for Strategic Initiatives in Global HIV Trials Hospital, San Patong Hospital, Chonburi Hospital, (INSIGHT) e purpose of this randomized study Chiangrai Prachanukroh Hospital, RIHES Chiang is to determine whether immediate initiation of Mai Univer- sity, Ramathibodi Hospital and antiretroviral treatment (ART) is superior to Bamrasnaradura Infectious Disease Institute
H I V- N AT ANNUAL REPORT 2 0 1 2 23 Status: Opened on June 25, 2009. Ongoing. initiated this last substudy and will be responsible Target/Enrolled: 65/88 HIV-NAT site; 250/166 for the data collection and sub-study analysis. ailand Status: Opened June 17, 2010. Closed to Collaborators: Chulalongkorn University, recruitment. Ongoing. Ploenchan Chetchotisakd (Srinagarind Hospital, Target/Enrolled: 120/122 ailand Khon Kaen University), Chonburi Regional Hospital. Collaborators: Ploenchan Chetchotisakd Siriraj Hospital, Mahidol University, Chiangrai (Srinagarind Hospital, Khon Kaen University) and Prachanukroh Hospital, Sanpatong Hospital, Khuanchai Supparatpinyo (Research Institute for Bamrasnaradura Infectious Disease Institute, Health Sciences (RIHES), Chiang Mai University) Ramathibodhi Hospital, Mahidol University, Sites: is study will involve 51 sites in 17 Research Institute for Health Sciences (RIHES), countries. ree sites in ailand. Chiang Mai University Sponsor: e Kirby Institute for Infection and Site PIs: Immunity in Society, University of New South Srinagarind Hospital, Khon Kaen University: Wales (UNSW), Sydney, Australia) and Bill & Ploenchan Chetchotisakd Melinda Gates Foundation Siriraj Hospital: anomsak Anekthananon San Patong Hospital: Virat Klinbuayaem ere are 3 substudies of which all are still Chonburi Hospital: ongoing in parallel with the main sudy: Chureeratana Bowonwatanuwong PK substudy Chiangrai Prachanukroh Hospital: HIV-NAT 128.1 Pacharee Kantipong A randomised, double-blind, placebo-controlled, RIHES Chiang Mai University: clinical trial to compare the safety and efficacy of Khuanchai Supparatpinyo reduced dose efavirenz (EFV) with standard dose Ramathibodi Hospital: Sasisopin Kiertiburanakul EFV plus 2N(t)RTI in antiretroviral-naïve HIV-infected Bamrasnaradura Infectious Disease Institute: individuals over 96 weeks Encore1 intensive Wisit Prasithsirikul pharmacokinetics sub-study Sponsor: e National Institute of Allergy and Status: Completed 2012 Infectious Diseases (NIAID) Division of AIDS Target/Enrolled: 10/10 (DAIDS) National Institutes of Health (NIH) Collaborators: Chelsea and Westminster Hospital, Publication: START; design considerations for a London, UK; Hospital J.M. Ramos Mejia, Buenos large simple trial to examine the time to commence Aires, ARGENTINA; Desmond Tutu HIV Foundation, antiretroviral therapy for the treatment of HIV Cape Town, SOUTH AFRICA; ai Red Cross-AIDS infection. J Clin Trials 2011. In press. Research Centre, HIV-NAT Research Collaboration, Bangkok, ailand ere are 10 substudies of which 8 are still ongoing: Funding: e Kirby Institute for Infection and 1. Arterial Elasticity : Closed enrolment Immunity in Society, University of New South Wales 2. Pulmonary (UNSW), Sydney, Australia) 3. Bone Mineral Density 4. Fibrosis Progression CNS substudy 5. Consent HIV-NAT 128.2 6. Genomic A randomised, double-blind, placebo-controlled, 7. Tissue biopsy for cancer in the future clinical trial to compare the safety and efficacy of 8. Storage sample (blood and urine) reduced dose efavirenz (EFV) with standard dose 9. Neuro : Closed enrolment EFV plus 2N(t)RTI in antiretroviral-naïve HIV-infected 10. Monitoring individuals over 96 weeks.
ENCORE1 (Evaluation of Novel Concepts in Neurocognitive substudy Optimization of antiRetroviral Effi cacy) HIV-NAT 128.3 HIV–NAT 128 e neurocognitive sub-study in Encore1: A A randomized, double-blind, placebo-controlled, randomised, double-blind, placebo-controlled, clinical trial to compare the safety and effi cacy of clinical trial to compare the safety and efficacy of reduced dose (400mg) efavirenz (EFV) with stand- reduced dose efavirenz (EFV) with standard dose ard dose EFV plus two nucleotide reverse tran- EFV plus 2N(t)RTI in antiretroviral-naïve HIV-infected scriptase inhibitors (N(t)RTI) in antiretroviral-naive individuals over 96 weeks HIV-infected individuals over 96 weeks. HIV-NAT is the ai co-ordinating centre. ere are three substudies: 1) CNS, 2) Intensive PK and 3) Neuro- cognitive substudy. Staff from HIV-NAT have
24 H I V- N AT ANNUAL REPORT 2 0 1 2 SECONDLINE (A randomized open-label HIV-infected adults study comparing the safety and effi cacy of Status: Opened on Oct 29, 2010. Ongoing ritonavir boosted lopinavir and 2-3N(t)RTI Target/ Enrolled: 100/68 HIV-NAT ; 560/300 backbone versus ritonavir boosted lopinavir ailand and raltegravir in participants virologically Collaborators: Wisit Prasithsirikul, Ploenchan failing first-line NNRTI/2N(t)RTI therapy: Chetchotisakd, Chureeratana Bowonwattanuwong, the SECOND-LINE study) Patcharee Kantipong, Sasisopin Kiertiburanakul, HIV–NAT 119 Virat Klinbuayaem, Supunnee Jirajariyavej, is is a Phase IIIb/IV, international, randomized, Warangkana Munsakul, Niramon Leerattanapetch, open label study comparing two regimens of Siritorn Nimitvilai, Sukit Bunjongkit, Malee Techa- combination antiretroviral therapy in people living pornroog and Supavadee Tongsakulrungraeng with HIV with confirmed virological failure of Protocol Shadow Team: Alli Humphries, Stephen first-line NNRTI/2N(t)RTI regimens. e study runs Kerr, and Mark Boyd for 96 weeks but the primary analysis takes place Mentors: David Cooper and Sean Emery at the week 48. Sites: Bamrasnaradura Infectious Disease Institute, Status: March 11, 2010. Closed to recruitment. Khon Kaen University, Chonburi Hospital, Chiang Ongoing. Rai Prachanukroh Hospital, Ramathibodi Hospital, Target/Enrolled: 100/67 ailand Sanpatong Hospital, Taksin Hospital, and Vajira Collaborators: Ploenchan Chetchotisakd Hospital, University of Bangkok Metropolitan (Srinagarind Hospital, Khon Kaen University), Administration, Khon Kaen Hospital, Nakornpathom Niramon Leeratanapetch (Khon Kaen Hospital), Hospital, Rayong Hospital Prapokklao Hospital, Khuanchai Supparatpinyo (Research Institute for Pranangklao Hospital
Health Sciences (RIHES), Chiang Mai University) Funding: NHSO and e Kirby Institute for Sites: Approximately 50 sites from Australia, Infection and Immunity in Society, University of Africa, Asia, Latin America, and Europe. New South Wales (UNSW), Sydney, Australia Four sites in ailand Presentation: Bencharat T, Chavalun R, Mark B, Sponsor: e Kirby Institute for Infection Peeraporn K, Chalandakorn R, Alli H, Wipada C, and Immunity in Society, University of New South Anchalee A, Kiat R, Torsak B on behalf of LASA Wales (UNSW), Sydney, Australia study team. Acceptability of web-based electronic ere is one substudy: 1. Bone and Body Comp: data capture in a multicentre randomized trial in A sub study of SECOND-LINE study ailand. [Poster # 265 ] presented at Australian HIV/AIDS Conference 2012 24th Annual LASA (Low dose Atazanavir/r vs. Standard Conference of the Australian Society for HIV dose Atazanavir/r) Medicine, Melbourne, Australia. 17-19 October HIV–NAT 110 2012 A multicenter randomized study to compare the effi cacy and safety of lower dose atazanavir/ ritonavir (ATV/r 200/100 mg OD) versus standard dose (ATV/r 300/100 mg OD) in combination with 2NRTIs in well virology suppressed
H I V- N AT ANNUAL REPORT 2 0 1 2 25 LASA HAIR substudy is cross-sectional study will evaluate the HIV-NAT 110.2 interest and attitudes on regular voluntary HIV is study will evaluate the atazanavir/ritonavir counseling and testing, assess the acceptability of concentration in hair immediate antiretroviral therapy if seropositive and Status: Oct. 25, 2011. Ongoing identify the associated factors in improving access Target/Enrolled: 400/193 to treatment and care. e information from this study will be used to design the upcoming Test Feasibility Study (Test and Treat) and Treat Study. HIV-NAT 162 Status: Opened on July 14, 2011. Ongoing Trial to Evaluate the Acceptability and Target/ Enrolled: 400/363 Feasibility of “Test and Treat” and “link-to-care” Collaborators: ai Red Cross Anonymous Clinic to reduce HIV transmission among men having Sites: ai Red Cross MSM Clinic, ai Red Cross sex with men in Bangkok Mobile Clinic Funding: HIV-NAT
NEW DRUG DEVELOPMENT
There are 8 studies investigating new drugs, 2 of which are conducted in children. Two studies were completed this year. All of these studies also investigated the pharmacokinetics, safety and efficacy of the new drugs. Two of the studies are conducted in naïve adults and one in experienced adult. One study evaluated the different doses while the other study was done in treatment stable patients. Few patients are required for the pharma studies which have many sites world wide but a much more stringent recruitment/enrollment timeline. HIV-NAT has completed 5 feasibility studies.
the time this went to press. Cobicistat, like ritonavir, is a pharmacokinetic booster but on its own has no HIV activity whereas elvitegravir is a new integrase inhibitor. Further developments for three new compounds (vicriviroc (a CCR5 inhibitor), GSK-761 (an NNRTI), and bevirimat (a maturation inhibitor)) have been discontinued. Other com- pounds are currently being investigated in phase 2-3 trials. As there are many compounds, we have picked a few of them that we have found exciting to mention: Rilpivirine (TMC-278), S/GSK1349572, Bevirimat (PA457 or MPC-4326) and Vivecon (MPC9055). Rilpivirine is a second-generation non- nucleoside reverse transcriptase inhibitor (non- nuke or NNRTI) to be administered once daily with Truvada as a fixed dose combination (FDC) tablet. S/GSK 1349572 is a next generation integrase From 100 new HIV drugs, this number has inhibitor that does not need to be administered been reduced to 60 as of 2012. On August 28, with a booster. Bevirimat (PA457 or MPC-4326) 2012, Stribild or formerly known as the QUAD and Vivecon (MPC 9055) are new drugs from a pill, composed of four drugs (Elvitegravir/cobicisat/ new class of drugs known as the maturation emtricitabine/tenofovir) was approved by the US inhibitor. Many pharmaceutical companies are FDA for once a day administration. However, now develo-ping FDCs which can be administered elvitegravir and cobicistat are not approved for use once daily which will definitely help improve the individually and are awaiting US FDA approval at patients’ adherence and quality of life.
26 H I V- N AT ANNUAL REPORT 2 0 1 2 THRIVE Status: Opened on April 7, 2011. Ongoing (http://clinicaltrials.gov/ct2/show/NCT00543725) Target/Enrolled: 1/1 HIV-NAT 091 Funding: Bristol-Myers Squibb A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. BMS - AI467003 in com-bination with a background regimen consis- (http://clinicaltrials.gov/ct2/show/NCT01489046) ting 2 nucleoside/nucleotide reverse transcriptase HIV-NAT144 inhibitors in antiretroviral-naïve HIV-1 infected A Phase IIb Randomized, Controlled, Partially subjects Blinded Clinical Trial to Investigate the Safety, Status: Closed June 2012 Effi cacy and Dose-response of BMS-986001 in Target/Enrolled: 20/18 Treatment-naive HIV-1-infected Subjects, Followed Funding: Tibotec Pharmaceuticals Ltd. by an open-label Period on the Recommended Dose. Status: Opened on May 2012. Ongoing TMC125-TiDP2-C238 Target/Enrolled: 25/21 (http://clinicaltrials.gov/ct2/show/NCT00896051) Funding: Bristol-Myers Squibb (BMS) HIV-NAT 137 A randomized, exploratory, open-label 48-week TMC278-TiDP6-C222 trial with a 2-week Pre-Treatment Phase to (http://apps.who.int/trialsearch/trial aspx? investigate the pharmacokinetics, safety, tolerability trialid= EUCTR2010-021209-18-IT) and antiviral activity of etravirine (ETR) in combina- HIV-NAT 150 tion with ritonavir-boosted atazanavir (ATV/rtv) An open-label trial with TMC278 25 mg q.d. in and 1 NRTI in treatment-experienced HIV-1 combination with a background regimen containing infected subjects 2 nucleoside/nucleotide reverse transcriptase Status: Closed 2012 inhibitors in HIV-1 infected subjects, who Target/Enrolled: 6/3 participated in TMC278 clinical trials. Funding: Tibotec Pharmaceuticals Ltd. Status: Opened on June 7, 2011. Ongoing Target/Enrolled: 13/13 GS-US-216-0114 Funding: Tibotec Pharmaceuticals Ltd. (http://clinicaltrials.gov/ct2/show/NCT01108510? term=GS-US-216-0114&rank=1) HIV-NAT 156 HIV-NAT 138 (http://clinicaltrials.gov/ct2/show/NCT00791700? is is a multicenter phase 3, randomized, term=maraviroc+AND+children&rank=1) double-blind, active-controlled study to evaluate An open-label, multicenter, multiple-dose pharma- the safety and effi cacy of a regimen containing cokinetic, safety and effi cacy trial of maraviroc in GS-9350-boosted atazanavir (ATV/GS-9350) combination with optimized background therapy versus ritonavir-boosted atazanavir (ATV/r) each for the treatment of antiretrovival-experienced administered with emtricitabine/tenofovir CCR-5 tropic HIV-1 infected children 2-<18 disoproxil fumarate (Truvada®, FTC/TDF) in HIV-1 e study will evaluate the effi cacy and safety of infected, antiretroviral treatment-naïve adult maraviroc in HIV-infected children. subjects. Status: Opened on Feb 3, 2011. Ongoing Status: Opened Sept 2, 2010. Ongoing Target/Enrolled: 2/1 Enrolled: 14 Funding: ViiV Healthcare Funding: Gilead Sciences MARCH study PRINCE 1 http://clinicaltrials.gov/ct2/show/NCT01384682? (http://clinicaltrials.gov/ct2/show/NCT01099579? term=the+kirby+institute&rank=11) term=PRINCE+1&rank=1) HIV-NAT 169 HIV-NAT 143 A randomised, open label study to evaluate A Prospective Single Arm, Open-label, Interna- the effi cacy and safety of maraviroc (MVC) as a tional, Multicenter Study to Evaluate the Safety, switch for either nucleoside or nucleotide analogue Effi cacy and Pharmacokinetics of Atazanavir reverse transcriptase inhibitors (N(t)RTI) or boosted (ATV) Powder Boosted with Ritonavir (RTV) Liquid protease inhibitors (PI/r) in HIV 1 infected individuals with an Optimized NRTI Background erapy, in with stable, well controlled plasma HIV RNA while HIV Infected Pediatric Patients Greater an or taking their first N(t)RTI + PI/r regimen of Equal to 3 Months to Less an 6 Years; Pediatric combination antiretroviral therapy (cART)) Atazanavir International Clinical Evaluation: the Status: Opened on May 31, 2012- Ongoing PRINCE I study (AI424397) Target/Enrolled: 15/8 is study will evaluate the pharmacokinetic and Funding: University of New South Wales, Kirby effi cacy data of atazanavir/r in HIV-infected children. institute
H I V- N AT ANNUAL REPORT 2 0 1 2 27 SEXUAL HEALTH
HIV-NAT has never had any sexual health studies until two years ago: HIV-NAT 114 and HIV-NAT 126. Since then, more sexual health studies are taking place. This year, there are four sexual health studies and one substudy. One study was completed in 2011 and two studies were completed this year, including one substudy. Two more studies are pending IRB approval at the time this was written. More sexual health studies designed by the nurses are in the pipeline.
“For several years HIV-NAT has been conducting Chaithongwongwatthana S. Age at menopause research in the field of sexual health. Every man and menopausal-related symptoms in ai HIV- and woman has a right to sexual health. In the infected women. Menopause: e Journal of e context of HIV, proper sexual health can contribute North American Menopause Society 2012: 19 (7) to the vertical and horizontal prevention of trans- mission of the infection. We have completed Preventive study in reproductive health and HIV studies on the sexual life of HIV-positive hetero- HIV-NAT 126 sexual men and women, on their intention for Contraception and the prevention of HIV conception and options for contraception, as well infection - conception and contraception in as on menopause in HIV-positive women. Currently ai people living with HIV we are evaluating different contraceptive methods, is is a cross-sectional study with two stages: including the uptake and continuation of use of stage 1 – questionnaire; stage 2 – focus group intrauterine devices in HIV-positive women, and discussion. e main goal is to assess sex practices, pharmacokinetic interactions between selected contraceptive methods used and the desire for antiretrovirals and combined hormonal contracep- conception in ai PLH via administering a ques- tion. We are also working with particular target tionnaire and conducting focus group discussions. groups of interest such as serodiscordant Target/Enrolled: 200/200 couples, and in 2013 we plan to begin research Status: Completed in March 2011. with adolescents.” – by Nadia Kancheva Landolt Publication: Landolt NK, Phanuphak N, Pinyakorn S, Lakhonphon S, Khongpetch C, Chaithongwong- HIV MENQOL watthana S, Ananworanich J. HIV-NAT 117 Sexual life, options for contraception and is is a cross-sectional study which evaluates the intention for conception in HIV-positivepeople quality of life and menopausal related symptoms on successful antiretroviral therapy in ailand. in ai HIV infected women aged 40 years and AIDS Care. 2012;24(7):897-904. older (HIV MENQOL cross sectional study). Target/Enrolled: 300/300 ere is one substudy: Status: Closed Feb 2012 HIV-NAT 126.1 Site: Pramongkutklao Hospital of the Royal Intrauterine Device as a modern method of ai Army contraception in ai HIV-positive women Funding: Chulalongkorn University (Ratchadapisek- is is a prospective study with a follow up period sompoch Grant) of six months. e main goal is to assess the Presentatation: Age at Menopause and Menopau- acceptance of and adherence to intrauterine device sal-related Symptoms in ai HIV-infected Women. (IUD) as a contraceptive method in ai HIV- [Poster #: P_34] presented at the 1st International positive women. Workshop on HIV & Women, from adolescent Target/Enrolled: 100/29 through menopause. Washington D.C., USA. 10-11 Status: Closed 2012 January 2011 Funding: Ratchadaphiseksomphot Fund, Faculty of Results: Age at menopause in HIV-infected ai Medicine, Chulalongkorn University, and HIV-NAT women was 47.3 years, which is significantly Results: Copper IUD, though currently not a earlier than the findings of a previous report on common choice among ai HIV-positive women, non-HIV-infected women. Postmenopausal HIV- could be accepted. Education on IUD risks and infected women had more vasomotor and sexual benefits is needed to promote the use of IUD in symptoms. addition to condoms as an effective contraceptive Published: Boonyanurak P, Bunupuradah T, option in HIV-infected women. Wilawan K, Loeanyod A, ongpaeng P, Chatvong Published: Manuscript has been submitted and D, Sophonphan J, Saeloo S, Ananworanich J, awaiting results
28 H I V- N AT ANNUAL REPORT 2 0 1 2 Pharmacokinetic hormonal study Published: First manuscript submitted to journal. HIV-NAT 147 Second manuscript is foreseen once sex steroid Pharmacokinetic interactions between sex hormones laboratory results are ready. steroid hormones and NNRTIs in HIV-positive ai Women Serodiscordant Couple Status: Closed on Dec 2, 2011; blood levels of sex HIV-NAT 168 steroid hormones – in process Reproductive health and HIV – Characterize HIV Target: 60 Enrolled 68 serodiscordance in heterosexual couples Funding: Ratchadaphiseksomphot Fund, Faculty Status: Opened on June 12, 2012, ongoing of Medicine, Chulalongkorn University, and HIV-NAT Target/Enrolled: 300 sero-discordant couples Results: In contrast to NVP, co-administrating approximately DSG/EE containing COC, with EFV was associated Collaborators: e ai Red Cross Anonymous Clinic with unfavorable progesterone and ARV levels. Funding: Ratchadaphiseksomphot Fund, Faculty of Our results suggest that NVP may be superior to Medicine, Chulalongkorn University, and HIV-NAT EFV when used with COC in HIV positive women.
OTHERS
In keeping with HIV-NAT’s desire to expand into other fields of study, currently there are 7 studies looking at various issues ranging from asthma to immunology to adherence. All of the studies are currently ongoing. One of the study looks at asthma while two investigate the immune response and another surveillancing HIV drug resistance and its new recombinant forms. One study examines voluntary counselling and testing (VCT) among MSMs whereas two other studies investigate adherence in adolescents and TB co-infected patients respectively. Other studies are being developed with experts from the geriatric, psychiatric and molecular biology departments as well as community non-governmental organizations (NGOs).
HIV-NAT is interested in other areas of study and (Division of Allergy & Immunology, Department is always looking for collaborators and/or partners of Pediatrics, the King Chulalongkorn Memorial to share this with. However, HIV-NAT also under- Hospital, Chulalongkorn University, Bangkok) stands the need to prioritize its work so each year, Site: HIV-NAT, the ai Red Cross AIDS certain areas are chosen to be further investigated. Research Centre and the King Chulalongkorn ere are many ideas for studies but for now, Memorial Hospital only those studies that can address the current Funding: CU Cluster RatchadapisekSompotch needs of HIV-NAT patients and ailand will be put Endowment Fund, Chulalongkorn University into motion.
Asthma Children with HIV and Asthma (CHIVAS) HIV-NAT 102 Allergen specific T effector and T regulatory cell response to common aeroallergens following immune restoration in HIV-infected children is aims to study allergen specific T effector and T regulatory cell response in HIV-infected children before and after commencement of HAART. Status: Opened on March 26, 2009. Ongoing Target/Enrolled: 20/8 Mentors: William T. Shearer (Baylor College of Medicine, TX, USA) and Pantipa Chatchatee
H I V- N AT ANNUAL REPORT 2 0 1 2 29 Immunology studies Ubolyam S, Avihingsanon A, Ananworanich J, CD4+poor response Ruxrungtham K, Cooper DA, Kelleher AD. A novel HIV-NAT 132 assay detecting recall response to Mycobacterium Prevalence, factors and immunopathogenesis of tuberculosis: Comparison with existing assays. inappropriate immune reconstitution (CD4+ below Tuberculosis (Edinb). 2012 Jul;92(4):321-7 200 cells/mm3) in ai patients with long term viral suppression following antiretroviral therapy. MSM VCT is is a retrospective, observational study that HIV-NAT 148 addresses why some HIV patients have CD4 <200 Multidisciplinary services to enhance HIV copies/mm3 despite being on ART and have viral testing and linkage to care among MSM load <50 copies/mL. is study will assess the is is a prospective cohort study which will factors contributing to this phenomenon and how determine the impact of MSM-targeted multidis- these patients differ compared to those with CD4 ciplinary services on uptake of HIV voluntary <200 copies/mm3. counseling and testing (VCT) and enrollment into Status: Opened on May 27, 2010. Ongoing care and retention of HIV-positive MSM. Target/Enrolled: 50/50 Status: Opened on March 3, 2011. Ongoing Funding: Ratchadaphiseksomphot Fund, Faculty of Target/Enrolled: 200 HIV-negative and 150 Medicine, Chulalongkorn University HIV- positive MSM participants Sites: TRC Anonymous Clinic, Sanglah Hospital, Restore study Bali, Indonesia and Cipto Mangunkusumo Hospital, HIV-NAT 136 Jakarta, Indonesia is is a prospective, observational study to Funding: e National Institute of Health (NIH)/ explore reconstitution of immunity in patients with President’s Emergency Fund for AIDS Relief advanced HIV-1-infection commencing combination (PEPFAR) Supplement, ai Red Cross – AIDS antiretroviral therapy. e protocol is designed to Research Centre and HIV-NAT mirror standard of care (SOC) visits for this patient Results: complete study at site Jakarta and Bali , population. e main difference to SOC is the during monitoring at site TRC formal collection of data and the collection of extra Published: plan data analysis in November and blood volumes. manuscript writing in December 2012 Four-year study Status: Opened on Sept. 2, 2010. Closed to Drug Resistance recruitment. Continuing to follow patients. Week HIV Drug Resistance Study 96 follow up has been completed in Oct 2012. HIV-NAT 158 Target/Enrolled: 50/53 Surveillance of HIV resistance transmission Funding: e Kirby Institute for Infection and and new HIV recombinant forms in ailand Immunity in Society, University of New South Status: Opened May 24, 2011 Wales (UNSW), Sydney, Australia Target/Enrolled: 160/103 Results: e CD25/CD134 assay showed good Collaborators: e ai Red Cross AIDS Research agreement with QFN-GIT I ndetecting recall Centre; Srinagarind Hospital, ailand; Chonburi response to TB both in well and less resourced Hospital, ailand; Chiangrai Prachanukroh setting as well as in persons with advanced HIV Hospital, ailand; Suratthanee Hospital, infection. ailand; Queen Savang Vadhana Memorial Published: Hsu DC, Zaunders JJ, Plit M, Leeman C, Hospital, ailand Ip S, Lampornsin T, Pett SL, Bailey M, Amin J, Funding: National Research Universities
30 H I V- N AT ANNUAL REPORT 2 0 1 2 Adherence study Presentatation: Risk Behaviors and Treatment TApHOD ACASI Adherence among HIV-infected Adolescents in the HIV-NAT 155 TREAT Asia Pediatric HIV Observational Database. e objective of this study is to collect [Poster# P 18] the International Workshop on information on adherence and behavioral risk HIV Pediatrics 2012. Washington D.C., USA 20-21 factors in HIV-infected adolescents who are July 2012 being followed in the TApHOD cohort study. Status: Opened on April 28, 2011. Closed to Questionnaire study recruitment. Adherence, associated factors and interventions Target/Enrolled: 50/50 (TB questionnaire study) Site: Chiangrai Prachanukroh Regional Hospital, HIV-NAT173 ailand; HIV-NAT, ailand; Kuala Lumpur Hospital Causes of discontinuity of tuberculosis treatment Pediatric Institute, Malaysia; Hospital Likas, and strategies to improve the treatment outcomes Malaysia; Hospital Raja Perempuan Zainab II, of tuberculosis in University Hospital Malaysia e objective of this study is survey of tuberculosis Funding: e American Foundation for AIDS in Bangkok will begin university hospital and new Research (amfAR), erapeutics Research, patient to find of cause of absence of drug and Education and AIDS Training in Asia (Treat Asia) loss follow up of treatment in the Chulalongkorn Results: e percentages of Asian HIV-infected hospital, for the reflect problem of tuberculosis in adolescents in this pilot study reporting risk-taking the big cities. behaviors, adherence problems, or having Status: Opened on Aug 7, 2012. Start Enrollment experienced stigmatization and violence were Nov 2012 generally low, appropriate psychosocial interven- Target/Enrolled: 1300/0 tions are needed to prevent and address these Funding: Chulalongkorn University (Ratchada- issues in HIV-infected adolescents aging into phiseksomphot Endowment Fund) adulthood.
PEDIATRIC AND YOUTH RESEARCH PROGRAMS
There are 22 ongoing pediatric and youth studies (14 HIV-NAT initiated, 4 collaborator-initiated, and 4 sponsor-initiated study). We also have more studies in adolescent including adherence project and HPV vaccination. We are having more publications from PREDICT substudies and early 2013 we will have result of PEARL study.
Even though our knowledge in the field of PREDICT pediatric HIV has been increasing, yet there are (Paediatric Randomized to Early vs Deferred still many unanswered questions because HIV Initiation in Cambodia and Thailand) treatment in infants and children differs from HIV-NAT 035 adults. New pediatric formulations continue is is an open label, randomized phase III study to be lacking. Long-term effects of various drugs comparing early versus deferred (starting HAART such as tenofovir are unknown. As these children when CD4+ falls below 15%) initiation of HAART in grow older and become teenagers, other anti-retroviral-naive children aged one to 12 years problems such as adherence and sexual trans with CDC paediatric clinical classification category mitted infections become important. Drug A or B and CD4+ between 15 to 24%. (NCT resistance and effects that alter the basic blood 00234091) profile such as increase in triglycerides and Status: Completed in 2011 cholesterol are a constant battle among Enrolled: 180 ai/120 Cambodian children pediatricians taking care of these patients. Site PIs in ailand: Bamrasnaradura Infectious Pediatric HIV continues to be challenging but Disease Institute: Jurai Wongsawat , Khon Kaen fulfilling as we learn more about it. University: Pope Kosalaraksa, Queen Savang
H I V- N AT ANNUAL REPORT 2 0 1 2 31 Vadhana Memorial Hospital: Wicharn Luesomboon, wat J, Luesomboon W, Vonthanak S, Ananwora- Nakornping Hospital: Suparat Kanjanavanit, nich J, Ruxrungtham K. Prevalence of HLA-B*5701 Chiangrai Regional Hospital: Rawiwan among HIV-Infected Children in ailand and Hansudewechakul, and Prapokklao Chantaburi: Cambodia: Implications for Abacavir Use. Pediatr Chaiwat Ngampiyasakul Infect Dis J. 2012 Sep 17. Site PIs in Cambodia: National Center for 8. Bunupuradah T, Ubolyam S, Hansudewechakul HIV/AIDS, Dermatology and STDs (NCHADS): R, Kosalaraksa P, Ngampiyaskul C, Kanjanavanit S, Mean Chhi Vun and Vonthanak Saphonn Wongsawat J, Luesomboon W, Pinyakorn S, Kerr Collaborator: David A. Cooper S, Ananworanich J, Chomtho S, van der Lugt J, Funding: National Institute of Allergy and Luplertlop N, Ruxrungtham K, Puthanakit T; Infectious Diseases (NIAID): Comprehensive PREDICT study group. Correlation of selenium and International Program of Research on AIDS zinc levels to antiretroviral treatment outcomes in (CIPRA) grant. Antiretroviral medication is provided ai HIV-infected children without severe HIV at no cost by GlaxoSmithKline (AZT, 3TC and symptoms. Eur J Clin Nutr. 2012 Aug;66(8):900-5. Abacavir), Boehringer Ingelheim (nevirapine), Merck 9. Kanjanavanit S, Puthanakit T, Vibol U, (efavirenz), Abbott (lopinavir/ritonavir) and Kosalaraksa P, Hansudewechakul R, Ngampiya- Hoffmann La Roche (nelfinavir). sakul C, Wongsawat J, Luesomboon W, Wongsabut Publications: J, Mahanontharit A, Suwanlerk T, Saphonn V, 1. Lessons from a multicentre paediatric HIV trial. Ananworanich J, Ruxrungtham K; PREDICT study Lancet. 2008 Aug 2;372(9636):356-7. group. High prevalence of lipid abnormalities 2. CD4 Cell Count Criteria to Determine When to among antiretroviral-naive HIV-infected Asian Initiate Antiretroviral erapy in Human Immunode- children with mild-to-moderate immunosuppres- ficiency Virus-Infected Children. Pediatr Infect Dis sion. Antivir er. 2011;16(8):1351-5. J.Oct;29(10):966-8 3. Ananworanich J, Apornpong T, Kosalaraksa P, Presentations: Jaimulwong T, Hansudewechakul R, Pancharoen C, 1) Five-year experience in ailand of using Bunupuradah T, Chandara M, Puthanakit T, CLIA and ISO to establish a laboratory network Ngampiyasakul C, Wongsawat J, Kanjanavanit S, for US NIAID Pediatric Clinical Trials. [CD Rom Luesomboon W, Klangsinsirikul P, Ngo-Giang- Abstract # CDD278] presented at the 6th IAS Huong N, Kerr SJ, Ubolyam S, Mengthaisong T, Conference on HIV Pathogenesis, Treatment and Gelman RS, Pattanapanyasat K, Saphonn V, Prevention. 17-20 July 2011. Rome, Italy. Ruxrungtham K, Shearer WT; PREDICT Study 2) Improved in iron status and anemia in HIV- Group. Characteristics of lymphocyte subsets in infected children after zidovudine-containing HIV-infected, long-term nonprogressor, and healthy HAART without routine iron supplementation. Asian children through 12 years of age. J Allergy [poster # MOPE255] presented at the 6th IAS Clin Immunol. 2010 Dec;126(6):1294-301 Conference on HIV Pathogenesis, Treatment 4. High prevalence of lipid abnormalities among and Prevention. 17-20 July 2011. Rome, Italy. Antiretroviral-naive HIV-infected Asian children with 3) Incidence and risk factors for nevirapine related mild to moderate immunosuppression. Antiviral toxicities among HIV-infected Asian children erapy. 2011;16(8):1351-5 randomized to starting ART at different CD4%. 5. Poor quality of life among untreated ai and [Poster # MOPE240] presented at the 6th IAS Cambodian children without severe HIV symptoms. Conference on HIV Pathogenesis, Treatment and AIDS care. 2012;24(1):30-8. Prevention. 17-20 July 2011. Rome, Italy. 6. Puthanakit T, Saphonn V, Ananworanich J, 4) Randomized clinical trial of immediate versus Kosalaraksa P, Hansudewechakul R, Vibol U, Kerr deferred antiretroviral therapy initiation in children SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, older than one year with moderate immunode- Luesomboon W, Ngo-Giang-Huong N, Chettra K, ficiency: e PREDICT Study (NCT00234091). Cheunyam T, Suwarnlerk T, Ubolyam S, Shearer [Poster # LBPE023; abstract # TULBPE023] WT, Paul R, Mofenson LM, Fox L, Law MG, Cooper presented at the 6th IAS Conference on HIV DA, Phanuphak P, Vun MC, Ruxrungtham K; on Pathogenesis, Treatment and Prevention. behalf of the PREDICT Study Group. Early versus 17-20 July 2011. Rome, Italy. deferred antiretroviral therapy for children older 5) Impact of Selenium and Zinc level on than 1 year infected with HIV (PREDICT): a multi- antiretroviral treatment outcomes in ai HIV- centre, randomised, open-label trial. Lancet Infect infected children. [Poster # P_29]* presented Dis. 2012 Oct 8. pii: S1473-3099(12)70242-6. at 3rd International Workshop on HIV Pediatrics. 7. Puthanakit T, Bunupuradah T, Kosalaraksa P, 15 - 16 July 2011, Rome, Italy and 6th IAS Vibol U, Hansudewechakul R, Ubolyam S, Suwan- Conference on HIV Pathogenesis, Treatment and lerk T, Kanjanavanit S, Ngampiyaskul C, Wongsa- Prevention. 17-20 July 2011. Rome, Italy.
32 H I V- N AT ANNUAL REPORT 2 0 1 2 ere are substudies for PREDICT Publication: 1. Response to planned treatment interruptions 1) HIV-NAT 035.1: is sub study assesses the in HIV infection varies across childhood. AIDS effect of immediate versus deferred antiretroviral (London, England). 2010 Jan 16;24(2):231-41 initiation on neurodevelopment in children with HIV 2. Adherence to Antiretroviral erapy and Accept- in Cambodia and ailand. Neurodevelopment is ability of Planned Treatment Interruptions in assessed every six months. e primary outcome HIV-Infected Children. AIDS and Behavior 2012 is the neurodevelopment functions in the immediate May 15 arm compared to the deferred arm at week 144. 3. Outcomes after reinitiating antiretroviral therapy Status: Closed in 2011 in children randomized to planned treatment Enrolled: 180 ai/120 Cambodian children interruptions in the PENTA 11 Study. Accepted by Funding: National Institute of Allergy and AIDS 2012 Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institute of Child HIV-NAT 080.3 Development (NICHD). Treatment response of chronic viral hepatitis B to 2) Micronutrient/HIV-NAT 035.2: is sub-study tenofovir and lamivudine-containing antiretroviral assesses the impact of selenium/zinc levels on HIV regimen in HIV-infected adolescents with chronic disease and treatment response in children. hepatitis B co-infection; HBV-HIV adolescent Status: Closed 2011 cohort Enrolled: 180 ai is study will investigate the treatment of HBV-co Funding: National Institute of Allergy and infection in HIV-infected children. Infectious Diseases (NIAID) Status: Opened on Dec. 15, 2011. Ongoing 3) PREDICT sub study- PREDICT Cohort Target/Enrolled: 3/0 HIV-NAT 035.3 Sites: Chiangrai Prachanukroh Hospital, Srinagarind Extension for HIV-NAT 035 Hospital, Khon Kaen University; Nakornping Status: Feb 20, 2007. Close May 2014. Hospital, Research Institute for Health Sciences Target/Enrolled: 300/283 and Chiang Mai University Site PIs in ailand: Bamrasnaradura Infectious Funding: amfAR, Treat Asia Disease Institute: Jurai Wongsawat, Khon Kaen University: Pope Kosalaraksa, Queen Savang HIV-NAT 090 Vadhana Memorial Hospital: Wicharn Luesomboon, An Open-label Study of Liquid and Sprinkled Nakornping Hospital: Suparat Kanjanavanit, Formulations of Efavirenz Administered in Chiangrai Prachanukroh Hospital: Rawiwan Combination with Didanosine and Emtricitabine Hansudewechakul, and Prapokklao Chantaburi: in HIV-infected Infants and Children 3 months to Chaiwat Ngampiyasakul. 6 years of Age (AI266922) Site PIs in Cambodia: National Center for HIV/ is study will evaluate the pharmacokinetic and AIDS, Dermatology and STDs (NCHADS): Mean efficacy of efavirenz in HIV-infected children. Chhi Vun and Vonthanak Saphonn Status: Closed 2012 Collaborator: David A. Cooper Funding: National Research Council of ailand 4) PREDICT Neuro Control group/ HIV-NAT 035.4 e neurodevelopment in normal children in Cambodia and ailand Status: Opened Oct 26, 2010 Target/Enrolled: 300/300
PENTA 11 HIV-NAT 066 is is a long term follow-up study assessing whether children with HIV infection undergoing planned ART interruptions are disadvantaged clinically, immunologically, virologically or neurologically from periods of time off ART. Status: Opened on Oct. 6, 2005. Ongoing until May 2013 Target/Enrolled: 9/9 Funding: Pediatric European Network for Treatment of AIDS (PENTA)
H I V- N AT ANNUAL REPORT 2 0 1 2 33 Site PIs in ailand: Kulkanya Chokephaibulkit, Jurai Wongsawat, Rawiwan Hansudewechakul, Pope Kosalaraksa, Suparat Kanjanavanit, Chaiwat Ngampiyakul, Pakarat Sangkla Collaborators/sites: Chulalongkorn Hospital, Siriraj Hospital, Bamrasnaradura Infectious Disease Institute, Chiang Rai Regional Hospital, Srinagarind Hospital Khon Kean University, Nakornping Hospital, Prapokklao Hospital and Surin Hospital Funding: Commission of Higher Education (CHE) Presentation: Pharmacokinetics of darunavir/ ritonavir in Asian HIV-1 infected children aged ≥ 6 years. [Poster #714] presented at the 18th Conference on Retrovirus and Opportunities Infections (CROI 2011). Boston, MA, USA. 27 February – 2 March 2011. 2. Ananworanich J, Target/Enrolled: 1/1 Prasitsuebsai W, Kosalaraksa P, Kanjanavanit S, Funding: Bristol-Myers Squibb Ngampiyaskul C, Wongsawat J, Sangkla P, Publications: in JAIDS review Suwarnlerk T, Sophonphan J, Hansudewechakul R, Wittawatmongkol O, Puthanakit T, Chokephaibulkit PAINT (TMC 278-C213) K. Outcomes of third-line antiretroviral therapy HIV-NAT 099 containing darunavir, etravirine or raltegravir in is is a phase II, open label, single arm multi- ai children with HIV infection. Presented at center trial evaluating the pharmacokinetics, XIX International AIDS Conference, Washington safety, tolerability and antiviral activity of Rilpivirine DC, USA. July 22-27, 2012 (TMC 278-C213) in naive HIV-infected adolescents between the ages of 12 and 18 years. MRI brain in Children Status: Opened on Jan. 29, 2009. Ongoing HIV-NAT 121 Target/Enrolled: 1/1 is is a prospective study that will compare Funding: Tibotec Pharmaceuticals the total brain volume between HIV-infected and healthy children by using multimodal imaging HIV-NAT 109 approach such as tensor-based morphometry Meaning of life in ai HIV infected youth (TBM) and diffusion tensor imaging (DTI). is is a randomized control trial. is study will Status: Ongoing evaluate the effect of logotherapy in HIV infected Enrolled/Target: 105/150 youths. Collaborators: Pope Kosalaraksa, Linda Aurpibul , Status: Opened on Nov 17, 2010. Ongoing Sukalaya Lerdlum, Victor Valcour, Paul ompson Target/Enrolled: 48/23 and Robert Paul Collaborator: Arunya Tuicomepee (Counseling Sites: SEARCH, Khon Kaen University, Chulalong- Psychology Program, Faculty of Psychology, korn University, Research Institute for Health Chulalongkorn University) Sciences (RIHES), Chiang Mai University, University Funding: Art AIDS Fund of California at San Francisco, University of Mis- souri and University of California at Los Angeles PIANO (TMC125-C213) Funding: National Institutes of Health HIV-NAT 112 is is a phase II, open-label multicenter trial KONCERT/PENTA 18 evaluating the safety, tolerability and antiviral HIV-NAT 124 activity of Etravirine (TMC 125-C213) in treatment A Kaletra ONCE daily Randomized Trial of the experienced HIV-infected children and adolescents. pharmacokinetics, safety and effi cacy of twice-daily Status: Closed 2012 versus once-daily lopinavir/ritonavir tablets dosed Target/Enrolled: 7/7 by weight as part of combination antiretroviral Funding: Tibotec Pharmaceuticals therapy in HIV-1 infected children is study will evaluate once daily lopinavir/ ird line HAART in HIV-infected children ritonavir-based HAART in virological suppressed HIV-NAT 113 children. is study will assess effi cacy and safety of third Status: Opened on July 15, 2010. Ongoing line regimen in 150 ai children. Target/Enrolled: 8/8 Status: Opened on August 17, 2010. Ongoing Funding: Paediatric European Network for Target/Enrolled: 150/56 Treatment of AIDS (PENTA)
34 H I V- N AT ANNUAL REPORT 2 0 1 2 HIV-NAT 133 TASER-P e objective of this study is to determine the HIV-NAT 149 effi cacy of TDF-based regimen in HIV-infected ai TASER-Pediatrics: Prospective Monitoring of children and assess effect of TDF on renal problem Second-line Antiretroviral erapy Failure and and bone mineral density. Resistance in Children Status: Opened on Dec. 16, 2010. Ongoing Status: Opened on Feb 3, 2011. Ongoing. Target/Enrolled: 36/35 Target/Enrolled: 300/264 Funding: National Research Council of ailand Collaborators: HIV-NAT, Cipto Mangunkusumo General Hospital, Research Institute for Health HPV Study Sciences, Chiang Mai University, Srinagarind HIV-NAT 139 Hospital. Khon Kaen University, Faculty of Medicine e objectives of this study is to compare the Siriraj Hospital, Mahidol University, University of prevalence of HPV infection among perinatally California San Francisco (UCSF), National Centre in HIV-infected adolescents, behaviorally HIV-infected HIV Epidemiology and Clinical Research, University adolescents, and HIV-negative adolescents, and of New South Wales, National Hospital of compare the prevalence of intraepithelial neoplasia Pediatrics (Benh vien Nhi Trung Uong), Children’s and presence of E6/E7 biomarker at cervical and Hospital Number 1, Children’s Hospital Number 2 anal sites among perinatally HIV-infected adoles- Funding: Foundation for AIDS Research, United cents, behaviorally HIV-infected adolescents, and States (amfAR)/TREAT Asia HIV-negative adolescents. Status: Opened on Dec 2, 2010. Closed to e PEARL study recruitment. Ongoing HIV-NAT 152 Target/Enrolled: 81/100 Pediatric study for Appropriate dose of Ritonavir Sites: HIV-NAT, Petchburi Hospital, Siriraj Hospital boosted Lopinavir in ai HIV-infected children and Chiangrai Prachanukroh Hospital is is a multicenter randomized study to compare Funding: e American Foundation for AIDS the safety and effi cacy of low-dose versus standard Research (amfAR), erapeutics Research, dose lopinavir/ritonavir containing HAART regimen Education and AIDS Training in Asia (Treat Asia) in virological suppressed HIV-infected ai children. Results: At least one-third of perinatally and Status: Opened on May 24, 2011. Ongoing. behaviorally HIV-infected adolescents had abnormal Target/Enrolled: 200/200 cytology and at least half had HPV infection and Sites: total 11 sites (HIV-NAT, ai Red Cross AIDS E6/E7 oncogenic mRNA. HIV positive adolescents Research Center, Bamrasnaradura Infectious need access to preventative HPV immunization Disease Institute, Khon Kaen University, Nakornping and routine monitoring for pre-cancerous and Hospital, Prapokklao Hospital, Queen Sirikit cancerous changes. National Institute of Child Health, Surin Hospital, Presentation: Ananworanich J, Prasitsuebsai W, Sappasitthiprasong Hospital, Udonthani Hospital, Kerr SJ, Phasomsap C, Pankam T, Rodbamrung P, Buddhachinaraj Hospital, Phrachomklao Hospital Teeratakulpisarn N, Petdachai W, Sohn, Phanuphak Funding: National Research Council of ailand N on behalf of the HIV-NAT 139 Study Group. and the Government Pharmaceutical Organization Prevalence of Cervical and Anal HPV Infection and Intraepithelial Neoplasia Biomarkers in Perinatally Improving Adherence in Adolescents and Behaviorally HIV-Infected Compared to HIV-NAT 171 HIV-Negative Adolescents. [Poster # S-147] Randomised Trial Comparing Two Interventions presented at the 19th Conference on Retrovirus to Improve Adherence to Combination Antiretro- and Opportunities Infections (CROI 2012). Seattle, viral erapy (cART) in Adolescents and Young WA USA. March 5-8, 2012. Adults with HIV in ailand Status: Opened on 24 July 2012 BREATHER/PENTA 16 Target/Enrolled: 110/91 HIV-NAT 140 Collaborators: HIV-NAT, SEARCH children and Short-Cycle erapy (SCT) (5 days on/2 days off) youth program, We Understand Group, Khon Kaen in young people with chronic HIV-infection University and AID Access Chiang Rai is study will evaluate the effi cacy and safety of Site: HIV-NAT, khon Kaen University, Phrachomklao short cycle therapy in HIV-infected children. Hospital, Petchaburi, Chaing Rai; Mae Chan Status: Opened on Sept. 16, 2010. Ongoing Hospital, Phan Hospital, Mae Suai Hospital, Mae Target/Enrolled: 20/18 Sai Hospital, Phraya Meng Rai Hospital, Somdej Funding: Paediatric European Network for Phra Yanna Sangworn Hospital and oeng Treatment of AIDS (PENTA) Hospital Funding: UNICEF ailand and TREAT Asia
H I V- N AT ANNUAL REPORT 2 0 1 2 35 HIV-NAT TEAMS
MEDICAL DEPARTMENT Left to right: Dr. Wasana Prasitsuebsai (Pediatrician, Allergist and Immunologist), Dr. Anchalee Avihingsanon (Head of HIV-NAT physicians and adult infectious disease specialist), Tawan Mengthaisong (MD Coordinator), Piraporn Ohata (MD Assistant), Prof. Kiat Ruxrungtham (Deputy Director of HIV-NAT and of ai Red Cross AIDS Research Centre), Assist. Prof. Wirach Maek-a-nantawat (Internist, Allergy and Immunology Specialist), Dr. Torsak Bunupuradah (Pediatrician, Allergist and Immunologist), Prof. Emer. Praphan Phanuphak (Co-director of HIV-NAT, Director of ai Red Cross AIDS Research Centre), Assoc. Prof. Jintanat Ananworanich (Deputy Director in Scientific Affairs at HIV-NAT), Dr. Denise Hsu (Adult Clinical Trial Physician), Chatsuda Auchieng (Grant Management), Dr. Reshmie Ramautarsing (Adult Clinical Trial Physician), Dr. Louise Tomlins (Adult Clinical Trial Physician)
Dr. Eugene Kroon Dr. Nicolas Durier Dr. Annette Sohn Dr. Nadia Kanchava Landolt Missing: Dr. Susie Dunachie
LABORATORY DEPARTMENT Left to right: atri Iampornsin (Scientist), Apicha Mahanontharit (Laboratory Quality Manager), Narukjaporn ammajaruk (Pharmacologist), Phantipa Onsam-ang (Laboratory Secretary), itiporn Somjit (Assistant Medical Technologist), Sasiwimol Ubolyam (Laboratory Manager), Patcharee Pararit (Assistant Medical Technologist), Patcharin Eamyoung (Medical Technologist), Dr. Denise Hsu (Adult Clinical Trial Physician), Bunruan Sopa (Medical Technologist), Umaporn Chobkarching (Scientist), Mattiga Pingthaisong (Assistant Medical Technologist), Kannika Khlungklang (Assistant Medical Technologist), Tanyathip Jaimulwong (Medical Technologist), Akekalak Khadnanta (Medical Technologist), Channuwat Bouko (Medical Technologist)
Missing : Meena Detchaiyasak (Pharmacologist)
36 H I V- N AT ANNUAL REPORT 2 0 1 2 HIV-NAT TEAMS
RESEARCH NURSE DEPARTMENT Left to right: Chonticha Rodchuea (Adult Clinical Research Nurse), Augchara Suwannawut (Secretary), idarat Cuprasitrut (Adult Clinical Research Nurse), ongsuai Chuanjaroen (Pediatric Clinical Research Nurse), Prachya Chaiyahong (Adult Clinical Research Nurse), Chuleeporn Wongvoranet (Adult Clinical Research Nurse), Amornrat Srimuan (Pediatric Clinical Research Nurse), Jaravee Jamthong (Adult Clinical Research Nurse), Sasirat Rakcharoenporn (Adult Clinical Research Nurse), Supalak Phonphithak (Head of Nursing Department), anaporn Mansawat (Assistant Research Nurse), Chompoonoot Sirikum (Pediatric Clinical Research Nurse), Parawee ongpaeng (Adult Clinical Research Nurse), Wanida iansanguankul (Adult Clinical Research Nurse), Nongyao Saysombut (Adult Clinical Research Nurse), Duangjai Chatvong (Administrator), Saowaluk Suksawek (Assistant Research Nurse), Siwanart ammasala (Assistant Research Nurse)
Missing : Paristaporn Sarachat (Assistant Research Nurse), Khuanruan Moonthong (Assistant Research Nurse)
CLINICAL RESEARCH ASSOCIATE Left to right: Kanchana Pruksakaew (Clinical Research Associate), Tulathip Suwanlerk (Head of Clinical Research Associate), Suwapit Prasertthanawut (Assistant Clinical Research Associate), idarat Jupimai (Clinical Research Associate), Oratai Butterworth (Junior Clinical Research Associate), Rommanee Anujit (Assistant Clinical Research Associate), Patsamon Rerksirikul (Assistant Clinical Research Associate), Saytiya Tongdaikly (Junior Clinical Research Associate), Kanlaya Charoentonpuban (Clinical Research Associate), Chanya Karapuks (Study Coordinator), Kanittha Pongjit (Junior Clinical Research Associate), Jintana Intasan (Clinical Research Associate)
Missing : Peeraporn Kaew-on (Clinical Research Associate), Kanitta Pussadee (Clinical Research Associate), Purivis Chart (Clinical Research Associate), Chalandakorn Ruengprasertkit (Clinical Research Associate)
H I V- N AT ANNUAL REPORT 2 0 1 2 37 HIV-NAT TEAMS
ADMINISTRATIVE DEPARTMENT Left to right: Pornwinit Sattayamongkol (Web Programmer), Dararin Choomsai Na Ayuthaya (Communication Specialist), Praneet Pinklow (Training Coordinator), Jeerakan Janhom (HR Coordinator & Offi ce Operation Head), Adisak Jamrasrak (Purchaser), Ruksina Chumchure (Administrator), Natthapa Pitayanon (Assistant HR Coordinator) Left to right: Apinya Phuttajitpunt (Housekeeper), Sommai Sattong (Housekeeper), Yodying Kittimakorn (Housekeeper)
BIOSTATISTICS DEPARTMENT Left to right: Suteeraporn Pinyakorn (Biostatistician), Siriwan Keadpudsa (Biostatistician), Jiratchaya Sophonphan (Biostatistician), Stephen Kerr (Head of Biostatistics), Tanakorn Apornpong (Biostatistician), Sirinya Teeraananchai (Biostatistician), Taweesak Channgam (Biostatistician)
38 H I V- N AT ANNUAL REPORT 2 0 1 2 HIV-NAT TEAMS
IT & DATA MANAGEMENT DEPARTMENT Left to right: Chowalit Phadungphon (Database Developer), Tanakorn Sritha (IT Help Desk), Patcharaporn Chusut (Clinical Data Associate), Orathai Chaiya (Junior Clinical Data Associate), Kittimuk Sansuk (IT Engineer), Prapon Koita (Database Programmer), Preecha Moopimon (IT Manager), Chavalun Ruengpanyathip (IT&Data Management Manager), Noppong Hirunwadee (Clinical Data Associate Supervisor), Ormrudee Rit-im (Senior Clinical Data Associate), Wanchai ongsee (Data Entry), Bencharat ongpunchang (Clinical Data Associate), eeradej Boonmangum (Clinical Data Associate)
Missing : Wipada Chanthaweethip (Clinical Data Associate)
PHARMACY DEPARTMENT Left to right: Niti Wongthai (Stock Controller), Parinya Sutheerasak (Pharmacist), Plengsri Lertarom (Head of Pharmacy), reepol Sattong (Pharmacist Assistant), Chulalak Sriheara (Pharmacist), Anuntaya Uanithirat (Pharmacist)
Missing : Ratree Longcharoen (Pharmacist Assistant), Sarapol Tongphan (Pharmacist Assistant)
FINANCIAL DEPARTMENT Left to right: Duangmanee Seedam (Finance Assistant), Umaporn Methanggool (Accountant), Chornarin angjitthanom (Accountant), Kesdao Nanthapisal (Financial Controller), Kanokon Sirichumpa (Finance Assistant)
H I V- N AT ANNUAL REPORT 2 0 1 2 39 PUBLICATIONS & WRITINGS
As o early September 2012, a total o 43 manuscripts have been accepted or publication and 18 manuscripts are under review. This year there are more publications in relatively a short time compared to last year. The reason or this is because the publication plan are periodically updated and ollowed to ensure that the manuscript is done according to the set timerame and works are prioritized.
This year, ten international grants and 21 Thai grants were submitted. Only eight international and fve Thai grants were awarded.
40 H I V- N AT ANNUAL REPORT 2 0 1 2 For Year 2012 Journal Publications Impact Factor Lancet Inectious Diseases 1 16.144 AIDS 1 6.245 International Journal o Epidemiology 1 5.759 Antimicrobial Agents and Chemotherapy 1 4.672 Journal o Acquired Immune Deciency Syndromes 2 4.262 Antiviral Terapy 5 3.774 Journal o North American Menopause Society 1 3.758 HIV Medicine 1 3.575 Expert Opinion on Pharmacotherapy 1 3.205 AIDS and Behavior 1 3.195 Pediatric Inectious Disease Journal 2 3.064 Journal o Medical Virology 2 2.895 uberculosis 1 2.65 Journal o Neurovirology 1 2.31 AIDS Research and Human Retroviruses 4 2.082 AIDS Research and Terapy 2 1.77 Journal o the International AIDS Society 1 1.76 Health Education & Behavior 1 1.742 AIDS Care 3 1.539 European Journal o Clinical Nutrition 2 2.563 HIV Clinical rials 1 1.835 Intervirology 1 1.756 Microbiology and Immunology 1 1.227 Future virology 1 1.2 Journal o the Association o Nurses in AIDS Care 1 1.090 International Journal o SD & AIDS 1 1.082 AIDS Research and reatment 2 0 Journal o Clinical rials 1 0 Open Virology Journal 1 0 otal 43 mean IF 2.95
2012 PUBLICATIONS
Bunupuradah , Pinyakorn S, Puthanakit . Puthanakit , Vonthanak S, Ananworanich J, Prevalence o selenium deciency in Tai HIV-inected Kosalaraksa P, Hansudewechakul R, Vibol U, Kerr children without severe HIV symptoms. Eur J Clin Nutr. SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, 2012 Aug 29. doi: 10.1038/ejcn.2012.116. [Epub Luesomboon W, Ngo-Giang-Huong N, Chettra K, ahead o print] No abstract available. Cheunyam , Suwarnlerk , Ubolyam S, Shearer W, Paul R, Moenson LM, Fox L, Law MG, Cooper DA, Zhou J, anuma J, Chaiwarith R, Lee CK, Law MG, Phanuphak P, Vun MC, Ruxrungtham K, on behal o Kumarasamy N, Phanuphak P, Chen YM, Kiertiburanakul the PREDIC Study Group. Early versus deerred S, Zhang F, Vonthanak S, Ditangco R, Pujari S, Choi JY, antiretroviral therapy or HIV-inected children older Parwati Merati , Yunihastuti E, Li PC, Kamarulzaman than one year o age: PREDIC - a randomised study. A, Nguyen VK, Tuy Pham , Lim PL. Loss to Followup Lancet Inectious 2012 In Press in HIV-Inected Patients rom Asia-Pacic Region: Results rom AHOD. AIDS Research and reatment Bunupuradah , Chetchotisakd P, Jirajariyavej S, 2012;2012:375217. Epub 2012 Feb 22. Valcour V, Bowonwattanuwong C, Munsakul W, Klinbuayaem V, Prasithsirikul W, Sophonphan J, Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol Mahanontharit A, Hirschel B, Bhakeecheep S, O, Gorowara M, Phongsamart W, Sophonphan J, Kerr Ruxrungtham K, Ananworanich J on behal o HIV SJ, Vanprapar N, Puthanakit , Pasomsap C, Suwanlerk SAR study group. Neurocognitive Impairment in , Sekar V, Burger D, Ananworanich J; the HIV-NA Patients Randomized to Second-line Lopinavir/ 113 Pharmacokinetic Study Group. Pharmacokinetics ritonavir-based Antiretroviral Terapy vs. Lopinavir/ o darunavir/ritonavir in Asian HIV-1 inected children ritonavir Monotherapy. Journal For Neurovirology. aged ≥7 years. Antiviral Terapy 2012 Sep 6 2012 In Press
H I V- N AT ANNUAL REPORT 2 0 1 2 41 angkijvanich P, Sa-nguanmoo P, Avihingsanon A, Kosalaraksa P, Bunupuradah , Vonthanak S, Ruxrungtham K, Poovorawan K, Poovorawan Y. Wiangnon S, Hansudewechakul R, Vibol U, Characterization o Hepatitis B Virus Mutations in Kanchanawanit S, Ngampiyaskul C, Wongsawat J, Untreated Co-inected Patients with HIV and HBV Luesomboon W, Lumbiganon P, Sopa B, Apornpong , Based on Complete Genome Sequencing. Journal o Chuenyam , Cooper DA, Ruxrungtham K, Medical Virology. 2012 In press Ananworanich J, Puthanakit . Prevalence o anemia and underlying iron status in naïve antiretroviral therapy Puthanakit , Bunupuradah , Kosalaraksa P, Vibol HIV-inected children with moderate immune suppression. U, Hansudewechakul R, Ubolyam S, Suwanlerk , AIDS Research and Human Retroviruses In Press 2012 Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Ananworanich J, Babiker A, Emery S et al. SAR; design considerations Ruxrungtham K on behal o the PREDIC study group. or a large simple trial to examine the time to commence Prevalence o HLA-B*5701 among HIV-inected children antiretroviral therapy or the treatment o HIV inection. in Tailand and Cambodia: implications or abacavir use. Journal o Clinical rials 2012 Pediatric Inectious Disease Journal. 2012 In Press Avihingsanon A, van der Lugt J, Singphore U, Gorowara Puthanakit , Saksawad R, Bunupuradah , M, Boyd M, Ananworanich J, Phanuphak P, Burger D, Wittawatmongkol O, Chuanjaroen , Ubolyam S, Ruxrungtham K. Pharmacokinetics and 48 Week Chaiwatanarat , Nakavachara P, Maleesatharn A, Ecacy o Adjusted Dose Indinavir/Ritonavir in Riam- Chokephaibulkit K. Prevalence and risk actors o low picin-reated HIV/uberculosis-Coinected Patients: bone mineral density among perinatally HIV-inected Tai A Pilot Study. AIDS Research and Human Retroviruses. adolescents receiving antiretroviral therapy. Journal o 2012 Mar 6 Acquired Immune Deciency Syndromes. 2012 In Press Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol Ramautarsing RA, van der Lugt J, Gorowara M, O, Gorowara M, Phongsamart W, Sophonphan J, Sophonphan J, Ananworanich J, Lange JMA, Burger Kerr SJ, Vanprapar N, Puthanakit , Pasomsap C, DM, Phanuphak P, Ruxthungtham K, Avihingsanon A. Suwanlerk , Sekar V, Burger D, Ananworanich J on Pharmacokinetics and 48 week saety and ecacy o behal o the HIV-NA 113 Pharmacokinetic Study generic lopinavir/ritonavir in Tai HIV-inected patients. Group. Pharmacokinetics o darunavir/ritonavir in Asian Short Communication. Antiviral Terapy 2012 In Press. HIV-1 inected children aged ≥7 years. Antiviral Terapy In Press 2012 Permpalung N, Putcharoen O, Avihingsanon A and Ruxrungtham K. reatment o HIV Inection with Puthanakit , Jourdain G, Suntarattiwong P, Choke- Once-Daily Regimens. Expert Opinion on Pharmaco- phaibulkit K, Siangphoe U, Suwanlerk , Prasitsuebsai therapy. 2012 In Press W, Sirisanthana V, Kosalaraksa P, Petdachai W, Hansudewechakul R, Waranawat N, Ananworanich J Bunupuradah , Chetchotisakd P, Ananworanich J, on behal o the HIV-NA 086 study team. High virologic Munsakul W, Jirajariyavej S, Kantipong P, Prasith- response rate ater second-line boosted protease sirikul W, Sungkanuparph S, Bowonwatanuwong C, inhibitor-based antiretroviral therapy regimens in children Klinbuayaem V, Kerr SJ, Sophonphan J, Bhakeecheep rom a resource limited setting. AIDS Research and S, Hirschel B, Ruxrungtham K; the HIV SAR Study Terapy 2012 Jun 18;9(1):20. Group. A randomized comparison o second-line lopinavir /ritonavir monotherapy vs. tenoovir/lamivudine/lopinavir Boonyanurak P, Bunupuradah , Wilawan K, Loeanyod /ritonavir in patients ailing NNRI-regimens: the HIV A, Tongpaeng P, Chatvong D, Sophonphan J, Saeloo SAR study. Antiviral Terapy 2012 Jul 2 S, Ananworanich J, Chaithongwongwatthana S. Age at menopause and menopausal-related symptoms in Tai HIV-inected women. Menopause: Te Journal o Te North American Menopause Society 2012: 19 (7)
Koken JA, Naar-King S, Umasa S, Parsons J, Saengcharnchai P, Phanuphak P, Rongkavilit C. A Cross-Cultural Tree-Step Process Model or Assessing Motivational Interviewing reatment Fidelity in Tailand. Health Education & Behavior 2012 Jan 6.
Ramautarsing RA, van der Lugt J, Gorowara M, Wongsabut J, Khongpetch C, Phanuphak P, Ananwo- ranich J, Lange JMA, Burger DM, Ruxrungtham K, Avihingsanon A. Neither branded nor generic lopinavir/ ritonavir produces adequate lopinavir concentrations at a reduced dose o 200/50 mg BID. Journal o Acquired Immune Deciency Syndromes 2012 Jan 1;59(1):55-58
42 H I V- N AT ANNUAL REPORT 2 0 1 2 Bunupuradah , Puthanakit , Kosalaraksa P, Kerr SJ, Winston A, Puls R, Kerr SJ, Duncombe C, Li PCK, Kariminia A, Hansudewechakul R, Kanjanavanit S, Gill JM, aylor-Robinson SD, Emery S, Cooper DA or Ngampiyaskul C, Wongsawat J, Luesomboon W, the ALAIR Study Group. Dynamics o cognitive change Chuenyam , Saphonn V, Vun M C, Vibol U, Vannary in HIV –inected individuals commencing three dierent B, Ruxrungtham K, Ananworanich J and on behal o antiretroviral regimens; a randomised, controlled study. the PREDIC study group. Poor quality o lie among HIV Medicine 2012 Apr;13(4):245-51 untreated Tai and Cambodian children without severe HIV symptoms. AIDS Care. 2012;24(1):30-8 Nguyen HL, Ruxrungtham K, Delaugerre C. Genetic Barrier to the Development o Resistance to Integrase Lim PL, Zhou J, Ditangco RA, Law MG, Sirisanthana , Inhibitors in HIV-1 Subtypes CRF01_AE and B. Kumarasamy N, Chen YM, Phanuphak P, Lee CK, Intervirology. 2012;55(4):287-95 Saphonn V, Oka S, Zhang F, Choi JY, Pujari S, Kamaru lzaman A, Li PC, Merati P, Yunihastuti E, Ananworanich J, Gorowara M, Avihingsanon A, Kerr Messerschmidt L, Sungkanuparph S; REA Asia HIV SJ, van Heesch N, Khongpetch C, Uanithirat A, Hill Observational Database. Failure to prescribe pneumo- A, Ruxrungtham K, Burger DM; HIV-NA 127 Study cystis prophylaxis is associated with increased mortality, eam. Pharmacokinetics o and short-term virologic even in the cAR era: results rom the reat Asia HIV response to low-dose 400-milligram once-daily observational database. Journal o the International raltegravir maintenance therapy. Antimicrobial Agents AIDS Society 2012 Jan 26;15:1 and Chemotherapy 2012 Apr;56(4):1892-8
Hamers RL, Oyomopito R, Kityo C, Phanuphak P, Le Nguyen H, Pitakpolrat P, Sirivichayakul S, Siwale M, Sungkanuparph S, Conradie F, Kumarasamy Delaugerre C, Ruxrungtham K. Minority HIV-1 resistant N, Botes ME, Sirisanthana , Abdallah S, Li PC, variants in recent inection and in patients who ailed Ngorima N, Kantipong P, Osibogun A, Lee CK, rst-line antiretroviral therapy with no detectable Stevens WS, Kamarulzaman A, Derdelinckx I, Chen YM, resistance-associated mutations in Tailand. Journal o Schuurman R, Vugt MV, Rinke de Wit F; on behal Medical Virology 2012 May;84(5):713-20 o the PharmAccess Arican (PASER) and REA Asia (ASER) Studies to Evaluate Resistance. Cohort Prole: Harrison L, Ananworanich J, Hamadache D, Te PharmAccess Arican (PASER-M) and the REA Compagnucci A, Penazzato M, Bunupuradah , Mazza Asia (ASER-M) Monitoring Studies to Evaluate Resis- A, Ramos J, Flynn J, Rampon O, Mellado Pena MJ, tance--HIV drug resistance in sub-Saharan Arica and the Floret D, Marczynska M, Puga A, Forcat S, Riault Y, Asia-Pacic. International Journal o Epidemiology 2012 Lallemant M, Castro H, Gibb DM, Giaquinto C; On Feb;41(1):43-54 Behal o the Paediatric European Network or reatment o AIDS (PENA) 11 rial eam. Adherence Khongphatthanayothin M, Avihingsanon A, to Antiretroviral Terapy and Acceptability o Planned eerata-kulpisarn N, Phanuphak N, Buajoom R, reatment Interruptions in HIV-Inected Children. AIDS Suwanmala P, Phanuphak P. Feasibility and Ecacy o and Behavior 2012 May 15 INH prophylaxis or latent tuberculosis in HIV inected Patients in Tailand. AIDS Research and Human Retroviruses 2012 Mar;28(3):270-5
H I V- N AT ANNUAL REPORT 2 0 1 2 43 Hsu DC, Zaunders JJ, Plit M, Leeman C, Ip S, Iampornsin Clarke A, Hsu D, Kerr SJ, Ramautarsing R, , Pett SL, Bailey M, Amin J, Ubolyam S, Avihingsanon Ohata pJ, Landolt NK, Avihingsanon A, Maek- A, Ananworanich J, Ruxrungtham K, Cooper DA, a-nantawat W, Puthanakit , Bunupuradah , Kelleher AD. A novel assay detecting recall response to Prasitsuebsai W, Ananworanich J, Ruxrungtham K. Mycobacterium tuberculosis: Comparison with existing Te 15th Bangkok International Symposium on HIV assays. uberculosis (Edinb). 2012 Jul;92(4):321-7 Medicine, Queen Sirikit National Convention Centre, Bangkok, Tailand, 17-19 January 2012.. Avihingsanon A, Ruxrungtham K, Katner H, Jean Future virology 2012;7(4):341-344 Guittari C, Walmsley S. Impact o baseline virologic, immunologic, and demographic characteristics on Avihingsanon A, Matthews GV, Lewin SR, Marks P, virologic responses in the gemini study. HIV Clinical Sasadeusz J, Cooper DA, Bowden S, SLocarnini, rials 2012 Mar-Apr;13(2):111-7 DoreGJ and Ruxrungtham K. Assessment o HBV fare in a randomized clinical trial in HIV/HBV coinected Aurpibul L, Lumbiganon P, Kolasaraksa P, Hansudewe- subjects initiating HBV-active antiretroviral therapy chakul R, Sa-Nguanmoo P, aeprasert P, Bunupuradah in Tailand. AIDS Research and Terapy 2012 , Pooworawan Y, Sirisanthana V, Puthanakit . Mar 9;9(1):6 HIV and Hepatitis B Co-inection among Perinatally HIV- inected Tai Adolescents. Te Pediatric Inectious Clarke A, Kerr S, Honeybrook A, Cooper DA, Disease Journal 2012 May 15. Avihingsanon A, Duncombe C, Phanuphak P, Ruxrungtham K, Ananworanich J and Kaldor J. Kerr SJ, Avihingsanon A, Putcharoen O, Chetchotisakd Adherence and Risk Behavior in Patients with HIV P, Layton M, Ubolyam S, Ruxrungtham K, Cooper DA, inection receiving Antiretroviral Terapy in Bangkok. Phanuphak P, Duncombe C. Assessing adherence in Te Open Virology Journal 2012;6:23-8 Tai patients taking combination antiretroviral therapy. International Journal o SD & AIDS. 2012 Mar; Maek-a-nantawat W, Avihingsanon A, and Ohata PJ. 23(3):160-5. Challenges in treatment and care or viral hepatitis in co-inected individuals with HIV in a resource-limited settings. AIDS Research and reatment 2012. In Press Bunupuradah B, Ubolyam S, Hansudewechakul R, Kosalaraksa P, Ngampiyaskul C, Kanjanavanit S, Wongsawat J, Luesomboon W, Pinyakorn S, Kerr S, Landolt NK, Phanuphak N, Pinyakorn S, Lakhonphon Ananworanich J, Chomtho S, van der Lugt J, S, Khongpetch C, Chaithongwongwatthana S, Luplertlop N, Ruxrungtham K, Puthanakit on Ananworanich J. Sexual lie, options or contraception behal o the PREDIC study group. Correlation o and intention or conception in HIV-positive people on selenium and zinc levels to antiretroviral treatment successul antiretroviral therapy in Tailand. outcomes in Tai HIV-inected children without severe AIDS Care. 2012 Jan 31 HIV symptoms. European Journal o Clinical Nutrition (EJCN) 2012 In press Wilkin A, Pozniak AL, Morales-Ramirez J, Steyn D, Santoscoy M, Grinsztejn B, Ruxrungtham K, Vanveggel Sitcharungsi R, Ananworanich J, Vilaiyuk S, Apornpong S, ermini R, Boven K. Long-term ecacy, saety, and , Bunupuradah , Pornvoranunt A, Nouanthong P, tolerability o rilpivirine (RPV, MC 278) in HIV type-1 Phasomsap C, Khupulsup K, Pancharoen C, Puthanakit inected antiretroviral-naïve patients: week 192 results , Shearer W, Benjaponpitak S; on behal o the rom a phase IIb randomized trial. AIDS Research and HIV-NA 108 Study Group. Nephelometry determined Human Retroviruses 2012; 28(5):437-446. serum immunoglobulin isotypes in healthy Tai children aged 2-15 years. Microbiology and Immunology 2012 Klinklom A, Puthanakit , Gorowara M, Phasomsap Feb;56(2):117-122. C, Kerr S, Sriheara C, Ananworanich J, Burger D, Ruxrungtham K and Pancharoen C. Low Dose o Rongkavilit C, Naar-King S, Koken JA, Bunupuradah , Lopinavir/ritonavir ablet Achieves Adequate Chen X, Saengcharnchai P, Panthong A, Parsons J. Pharmacokinetic Parameters in HIV-Inected Tai A Feasibility Study o Motivational Interviewing or Adolescents. Antiviral Terapy 2012;17(2):283-9 Health Risk Behaviors Among Tai Youth Living With HIV. J Assoc Nurses AIDS Care. 2012 Jun 8. Praditpornsilpa K, Avihingsanon A, Chaiwatanarat , Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba Rungsiyanont S, Vacharotayangul P, Lam-Ubol A, A, Avihingsanon Y, Ruxrungtham K, unsanga K, Ananworanich J, Phanuphak P, Phanuphak N. Eiam-Ong S, Phanuphak P. Comparisons between Perceived dental needs and attitudes toward dental validated estimated glomerular ltration rate (GFR) treatments in HIV-inected Tais. AIDS Care. 2012 equations and isotopic GFR in HIV patients. AIDS. Mar 20. 2012 Sep 10;26(14):1781-8
44 H I V- N AT ANNUAL REPORT 2 0 1 2 PRESENTATIONS AT CONFERENCES AND MEETINGS
At the time o preparing this annual report, a total o 37 abstracts were accepted, two o which were oral presentations. A total o eight abstracts were accepted at CROI 2012; there were fve pediatric abstracts, two on nephrology and one on vitamin D. There were a total o seven abstracts rom AIDS 2012 (three were on children, two were on MSM, and one each on fxed dose combination (FDC) TDF/3TC/EFV in adults and website) and six rom ASHM 2012. Two abstracts are rom the Clinical Research Associates and one rom the Clinical Data Associate. This is the frst time that the Data Management Team has participated in submitting abstracts to conerences. As or the ICID 2012, a total o six abstracts were submitted o which three were in the pediatric population, and one each on syphilis, hepatitis and prep. As or the Pediatrics workshop, there were 4 abstracts and ollowing that is Glasgow with three abstracts. The ID, ACPID and Liver conerence each had one abstract.
H I V- N AT ANNUAL REPORT 2 0 1 2 45 19Th CONFERENCE ON RETROvIRUS AND Ananworanich J, Prasitsuebsai W, Kerr SJ, Phasomsap OPPORTUNITIES INFECTIONS (CROI 2012). C, Pankam , Rodbamrung P, eeratakulpisarn N, SEATTLE, WA USA. MARCh 5-8, 2012. Petdachai W, Sohn, Phanuphak N on behal o the HIV-NA 139 Study Group. Prevalence o Cervical and Anal HPV Inection and Intraepithelial Neoplasia Bio- Bunupuradah , Chetchotisakd P, Jirajariyavej S, Valcour markers in Perinatally and Behaviorally HIV-Inected Com- V, Bowonwattanuwong C, Munsakul W, Klinbuayaem pared to HIV-Negative Adolescents. [Poster # S-147] V, Prasithsirikul W, Sophonphan J, Ananworanich J on behal o HIV SAR study. Neurocognitive Impairments in Patients Using Lopinavir/ritonavir Monotherapy vs Puthanakit , Ananworanich J, Vonthanak V, Kosa- Lopinavir/ritonavir-based HAAR. [Poster # E-198] ralaksa P, Hansudewechakul R, Kerr SJ, Kanjanavanit S, Vibol U, Paul R, Ruxrungtham K on behal o the PREDIC Study Group. Neurodevelopmental Outcome Kosalaraksa P, Ananworanich J, Puthanakit , Pinya- Among HIV-inected Children Older Tan 1 Year o Age korn S, Chuanjaroen , Lumbiganon P, Chobkarjing U, Randomized to Immediate vs Deerred Antiretroviral Phanuphak P, Pancharoen C, Bunupuradah on behal Terapy: Te PREDIC Study (NC00234091). o the HIV-NA 077 Study eam. Lopinavir/ritonavir [Oral # S-143] (oral presentation) Monotherapy in HIV-inected Children; week 144 results. [Poster # S-118] Praditpornsilpa K, Avihingsanon A, Chawatanarat , Chaiyahong P, Wongsabut J, Ubolyam S, Chulaka- Rongkavilit C, Naar-King S, Klungkang S, Parsons J, dabba A, Avihingsanon Y, Eiam-Ong S, Phanuphak P. Bunupuradah , Chuenyam , Koken J, Phanuphak P. Validation o Estimated Glomerular Filtration Rate Correlations o Sexual Risks, Alcohol Use, and Antire- (GFR) Equations Compared With the Isotopic GFR in troviral Adherence in HIV+ Tai Youth. [Poster # S-131] an HIV Inected Patients [Poster # O-188]
46 H I V- N AT ANNUAL REPORT 2 0 1 2 Avihingsanon A, Praditpornsilpa K, Ramautarsing R, XIX INTERNATIONAL AIDS CONFERENCE, Wongsabut J, Clark A, Mek-Anantawat W, Ubolyam WAShINGTON DC, USA. JULy 22-27, 2012 S, Avihingsanon Y, Hiransuthikul N, Ruxrungtham K. Increased risk o Subclinical Kidney ubular abnormalities in HIV-inected individuals on long term Antiretroviral Avihingsanon A, Tainsanguankul W, Wongsabut J, Terapy: Asian cohort perspective. [Poster # O-195] Gorowara M, Ramautarsing R, Clarke A, Mek-a- nanthawat W, Hsu, D, Ruxrungtham K. Virologic suc- cess at week 48 among HIV inected Tais using once Ramautarsing R, Avihingsanon A, Praditpornsilpa K, daily single xed drug combination tablet o tenoovir, Wongsabut J, Clarke A, Maek-a-nantawat W, Ubolyam lamivudine and eavirenz (300/300/600) S, Khovidhunkit W, Hiransuthikul N, Ruxrungtham K. Prevalence o and Risk actors or Hypovitaminosis D among HIV-inected Adults living in the ropics. Bunupuradah , Kosalaraksa P, Vibol U, Hansudewe- [Poster # O-189] chakul R, Wongsabut J, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Anan- woranich J, Ruxrungtham K, Puthanakit on behal o the PREDIC study group. Impact o antiretroviral 15Th INTERNATIONAL CONGRESS ON therapy on quality o lie in HIV-inected children with moderate immune deciency; week 144 results o the INFECTIOUS DISEASES AND ThE INTERNA- PREDIC randomized control study TIONAL SOCIETy FOR INFECTIOUS DISEASES, JUNE 13-16, 2012, BANGkOk, ThAILAND Ananworanich J, Prasitsuebsai W, Kosalaraksa P, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Puthanakit , Bunupuradah , Kosalaraksa P, Vibol Sangkla P, Suwarnlerk , Sophonphan J, Hansudewe- U, Hansudewechakul R, Ubolyam S, Kanjanavanit chakul R, Wittawatmongkol O, Puthanakit , S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Chokephaibulkit K. Outcomes o third-line antiretroviral Saphonn V, Ananworanich J, Ruxrungtham K and on therapy containing darunavir, etravirine or raltegravir in behal o the PREDIC study group. Low prevalence o Tai children with HIV inection HLA B5701 among HIV-inected Tai children in Tailand and Cambodia; implication or abacavir use Kanjanavanit S, Puthanakit , Kosalaraksa P, Hansudewechakul R, Ngampiyaskul C, Pinyakorn S, Ubolyam S, Puthanakit , Kerr SJ, Kosalaraksa P, Luesomboon W, Saphonn V, Ananworanich J, Ruxrung- Vibol U, Hansudewechakul R, Kanjanavanit S, Ngampi- tham K and on behal o the PREDIC studygroup. yaskul C, Wongsawat J, Luesomboon W, Vonthanak S, Lipid prole in children randomized to immediate versus Ananworanich J, Ruxrungtham K on behal o the deerred nevirapine-based antiretroviral therapy in the PREDIC study group. Plasma HIV viral load and C- PREDIC study (oral presentation) reactive protein as predictors o HIV disease progression among HIV-inected children. Yunihastuti E, Phanuphak N, Merati P, Somia A, Jeo Ws, Indriatmi W, Sukjitpaiboonphol A, Channgam , Phongsamart W, Hansudewechakul R, Bunupuradah , Ananworanich J, Phanuphak P on behal o the MSM Rakskulkarn P, Keadpudsa S, eeraananchai S, Kerr SJ, VC Study Group. Sexual practice among HIV-positive Ananworanich J, Chokephaibulkit K. Long-erm and HIV negative/unknown status men who have sex Outcomes o HIV-Inected Children in Tailand: the with men in Bangkok, Bali and Jakarta. Tailand Pediatric HIV Observational Database. Poster # 43.023 Phanuphak N, Merati P, Yunihastuti E, Somia A, Jeo WS, Lisnawati, Sukjitpaiboonphol A, Channgam , Maek-a-nantawat W, Jamthong J, Laopraynak N, Ananworanich J, Phanuphak P on behal o the MSM Moonthong K, Ubolyam S, Avihingsanon A. Syphilis and VC Study Group. High prevalence o abnormal anal Risk behaviors among HIV-inected individuals on antiret- cytology among HIV-positive and HIV-negative men who roviral therapy. Poster # 51.008 have sex with men in Bangkok, Bali and Jakarta.
Ananworanich J. Implementing PrEP - Are we Ready?” Nitpolprasert C, Anand , Ananworanich J, Phanuphak P, Sathianthammawit W, Pakam C, Phanuphak N. Avihingsanon A. Hepatitis B Coinection: Implication or “Adam’s Love – For Men Who Love Men”, an online management communication campaign through an edutainment web- site to promote HIV testing among men who have sex with men (MSM) in Tailand.
H I V- N AT ANNUAL REPORT 2 0 1 2 47 4Th INTERNATIONAL WORkShOP ON hIv Bencharat , Chavalun R , Mark B , Peeraporn K , PEDIATRICS, JULy 20-21, 2012, WAShINGTON Chalandakorn R, Alli H , Wipada C, Anchalee A , Kiat R, DC, USA orsak B on behal o LASA study team. Acceptability o web-based electronic data capture in a multicentre randomized trial in Tailand. [Poster # 265 ] Prasitsuebsai W, Pang J, Hansudewechakul R, Razali K, Yusof N, Moy FS, eeraananchai S, Kerr SJ, Anan- woranich J and Sohn AH. Risk Behaviors and reatment Kerr, SJ, Rattanamahattana, M, Chetchotisakd, P, Adherence among HIV-inected Adolescents in the Cabarrubias, H, Putcharoen, O, Ananworanich, J, Imrie, REA Asia Pediatric HIV Observational Database J, Cooper, DA, Phanuphak, P, Avihingsanon, A. Supportive relationships with the clinic team empowers Tai people living with HIV to maintain excellent Panthong A, Kosalaraksa P, Wongsabut J, Puthanakit adherence [poster # 276] , Lumbiganon P, Chuanjaroen , Sopharak C, Prasit- suebsai W, Ananworanich J, Bunupuradah on behal o the HIV-NA 077 Study eam. Quality o lie in Kerr, SJ, Gorowara, M, Phonphitak, S, Ananworanich, HIV-inected children using treatment simplication to J, Burger, D, Ruxrungtham, K, Avihingsanon, A. lopinavir/ritonavir monotherapy Predictors o daily tenoovir exposure in Tai subjects taking combination antiretroviral therapy. [Poster # 368].
Bunupuradah , Imahashi M, Iampornsin , Matsuoka, Iwatani, Puthanakit , Ananworanich J, Sophonphan J, Chalandakorn R, Ploenchan C, Supunnee J, Apicha M, Mahanontharit A, Naoe , Phanuphak P, Sugiura W Jiratchaya S, Victor G. V, Chureeratana B, Warangkana on behal o the PREDIC Study eam. Association M, Virat K, Wisit P, Peeraporn K, Bernard H, Kiat R, o APOBEC3G and disease progression in Tai and Jintanat A, orsak B on behal o HIV SAR study Cambodian HIV-inected children with moderate immune group. Neurocognitive impairment and cerebrospinal deciency. fuid HIV-RNA in Tai HIV-inected adults ailing non-nucleoside reverse transcriptase inhibitor based antire-troviral therapy. [Poster #755] Jantarapakde J, Pancharoen C, eeratakulpisarn S, Mathajittiphan P, Kriengsinyot R, Channgam , Pengnonyang S, Jupimai , Plodgratok P, Lakhonphon S, Luesomboon W, Jadwattanakul , Avihingsanon A, A JOINT MEETING OF IDSA, ShEA, hIvMA, Phanuphak N, Ananworanich J, Ungaro P, Phanuphak P. Willingness o Tai HIV-inected parents to disclose AND PIDS. SAN DIEGO, CA, USA. their HIV status to their children. 17-21 OCTOBER 2012.
Ngampiyaskul C, Vibol U, Sophonphan J, Hansudewe- chakul R, Vonthanak S, Kosalaraksa P, Kanjanavanit,S, ThE LIvER MEETING, ANNUAL MEETING Wongsawat J, Luesomboon W, Suwanlerk , Fox L, OF ThE AASLD - AMERICAN ASSOCIATION Ananworanich J, Ruxrungtham K, Puthanakit on FOR ThE STUDy OF LIvER DISEASES, behal o the PREDIC study group. Growth outcomes BOSTON, MA, USA. 11-13 SEPT 2012 in children randomized to early versus deerred antiret- roviral therapy in the PREDIC study. [Poster # 36283].
Ali RJ, Bowden S, Avihingsanon A, Lewin SR, Ruxrungtham K, Locarnini S, Sasadeusz J, Dore GJ and Matthews GV. Changes in Quantitative HBsAg and INTERNATIONAL CONGRESS ON DRUG HBeAg Predict HBV reatment Response in HIV/HBV ThERAPy IN hIv. GLASGOW, GLASGOW, Uk. Coinected Individuals on enoovir based HAAR in Tailand. 11-15 NOvEMBER 2012
Avihingsanon A, Mek-A-nantawat W, Apornpong , Akkarathamrongsin S, Ubolyam S, Chomhong P, ang- AUSTRALIAN hIv/AIDS CONFERENCE 2012 kitvanich P. Distribution o HCV genotype and Single 24Th ANNUAL CONFERENCE OF ThE Nucleotide Polymorphisms (SNPs) o IL-28B gene in AUSTRALIAN SOCIETy FOR hIv MEDICINE, HIV/HCV coinected Tai Populations. [Poster # P132] MELBOURNE, AUSTRALIA. 17-19 OCTOBER 2012 Avihingsanon A, Praditpornsilpa K, Avihingsanon Y, Wongsabut J, Klongpetch C, Ubolyam S, Ruxrungtham K. Association o Fibroblast growth actor 23 and hypo- Pussadee K, Clarke A, aylor J, Kerr S, Avingsanon A , phosphatemia in well suppressed HIV inected patients Keawon P, Emery S, Phanuphak P, Puls R. Experience in receiving antiretroviral therapy. [Poster # P046] setting up a Tai Coordinating Centre. [Poster # 130]
48 H I V- N AT ANNUAL REPORT 2 0 1 2 Maekanantawat W, Avihingsanon A, Tainsanguankul 6Th ASIAN CONGRESS OF PEDIATRIC W, Wongsabut J, Gorowara M, Ramautarsing R, Clarke INFECTIOUS DISEASES (ACPID 2012). BMICh, A, Hsu D, Ruxrungtham K. Saety and e cacy o once COLOMBO, SRI LANkA. 28 NOv – 1 DEC 2012 daily single generic xed drug combination tablet o tenoovir, lamivudine and eavirenz among HIV inected Tais. [Poster # P312] Bunupuradah , echasaensiri, Keadpudsa S, Tam- majaruk N, Srimuan A, Sahakijpicharn , Prasitsuebsai W, Ananworanich J, Puthanakit . on behal o the HIV- Avihingsanon A, Maek-a-nantawat W, Ananworanich J, NA 146 study team. Pharmacokinetics o atazanavir/ Sithinamsuwan P, Suksawak S, Saysombut N, ritonavir among Tai HIV-inected children concomitantly Charoenporn W, Valcour V. Impaired neurocognitive taking tenoovir disoproxil umarate. Oral presentation unction among HIV-inected Tais on stable antiretro- A-477-0009-00205. viral therapy or more than 7 years. [poster # P220]
Maek-a-nantawat W, Phanuphak N, eeratakulpisarn N, Kanteeranon , Chaiya O, Mansawat , Ananworanich J, Phanuphak P. Interest in the “est and reat” strategy or HIV prevention among men who have sex with men living in Bangkok. [poster # P231]
H I V- N AT ANNUAL REPORT 2 0 1 2 49 HIV-NAT RESEARCH LABORATORY
The HIV-NAT Research Laboratory is located on the 7th foor o the Research Building at Chulalongkorn University Hospital, which is 150 eet rom the HIV-NAT main building. HIV-NAT laboratory serves as the central laboratory or the PREDICT study. In addition, HIV-NAT is responsible or training, quality assurance, data collection and analysis or all sites.
50 H I V- N AT ANNUAL REPORT 2 0 1 2 Te HIV-NA laboratory acility comprises approximately Pathologists (CAP) or ow cytometry. Viral quantitation 2500 square eet o space. Te laboratory has the is certied by Virology Quality Assessment Program capacity to perorm diagnostic immunoassays, cell (VQA) rom Rush Presbyterian-St. Lukes Medical Center phenotyping by ow cytometry, HIVRNA, hepatitis and Chicago, Illinois, and also rom CAP. All laboratory assays syphilis serology and molecular testing, haematology, has external quality assurance program with CAP or chemistry and HIV pharmacokinetics. CAP approved provider. HIV-NA laboratory has already received CAP accreditation in April 2009 (LAP Te laboratory provides serum HIV and diagnostic Number :7197506, AU-ID : 1475967). A PC network serology testing or HIV, HBV and HCV, and molecular has been established throughout the laboratory. Te quantitation o HIV by Cobas Ampliprep aqman Cobas I 5000 Solution laboratory inormation system (Roche),and Abbott Molecular, CMV as well as MB/ was implemented to HIV-NA laboratory, the unctions RIF assay by B Xpert. Te laboratory also provides implemented in HIV-NA laboratory considerably 2-, 3- and 4-color ow cytometry or -cell phenotype increase eciency in all areas o laboratory workows analysis or adult and paediatric studies. rom quality control and order processing all the way to the technical/medical validation o the patients’ samples. Tere is computer system or each tech-nicians con- HIV-NA Research Laboratory has been perorming nected to the network with direct access to printing pharmacokinetics and therapeutic drug monitoring and the Internet. studies or several years. HIV-NA PK laboratory has provided commercial services or therapeutic drug HIV-NA research laboratory serves as the central monitoring or tenoovir, eavirenz, nevirapine, ralte- specimen repository or many studies. Te laboratory gravir and all protease inhibitors. Our research studies is in compliance with all applicable saety and adminis- ocus on issues relevant to the Asian setting such as trative requirements or GCLP and is audited annually dose reduction o several antiretrovirals and quality by staf rom NCHECR, St Vincent’s Hospital, Sydney, assessment o many generic products. Australia and DAIDS ocer, USA.Te specimen storages are kept in -70 reezer. HIV-NA laboratory handles Our pharmacokinetic laboratory participates in the specimen storage or both short-term and long-term Association or Quality Assessment in Terapeutic Drug storage, thereore the adequate o equipment, acilities Monitoring and Clinical oxicology (KKG) program and management o specimen repository at HIV-NA Te laboratory participates in the college o American pose a challenge.
H I V- N AT ANNUAL REPORT 2 0 1 2 51 HIV-NA research laboratory has been responsible or shipping samples rom all sites. HIV-NA laboratory staf members have been trained on shipment o biological samples and given a manual to ollow. Tis document includes inormation on how to properly classiy, package, mark and label shipment. Diagnostics Specimens, inectious substances and other biological materials are regulated by International Air ransport Association (IAA). Inectious substances and materials categorized as “Dangerous Goods” are always transported according to the appropriate regulations. HIV-NA has several staf members that are IAA-certied. Tey provide training to other staf every 2 years.
Te HIV-NA laboratory has been involved with processing, storing and shipping o research specimens, including peripheral blood mononuclear cells (PBMCs), or the NIH sponsored studies or the past 10 years. HIV-NA Laboratory acts as a local central lab or Peripheral Blood Mononuclear Cells (PBMC) procedure or the management o MERCK clinical research study as well as GSK clinical research study in the uture.
Staf: Laboratory Director: Pro. Kiat Ruxrungtham Laboratory Manager: Sasiwimol Ubolyam Laboratory Quality Manager: Apicha Mahanontharit otal number o staf: 18, consist o 7 Laboratory Medical echnologist, 2 Scientist, 2 Pharmacologist, 2 Senior Laboratory assistant, 2 laboratory assistant and 1 lab Secretary and 1 part time Medical echnologist
Auditor/Consultant: Phillip Cunningham, Te HIV-NA research laboratory has been identied senior operations manager, as a model, operating in accordance with the principles St.Vincent’s hospital, Australia o Good Laboratory Practice required by pharmaceutical Mike Ussery, industry. Much o the work o the laboratory is directed Division o AIDS, NIH, USA towards the provision o routine clinical support or clinical trials and specimen preparation. Te laboratory Neal Wetherall, unctions as a central laboratory or multi-centre studies, Division o AIDS, NIH, USA including sites throughout Tailand and a large number o national and international pharmaceutical clinical trials.
In addition, in 2012, HIV-NA Research Laboratory received the Tailand Biorisk Management Champions Award or its excellent management o Biosaety level 2 in clinical laboratory. Tis award was bestowed to laboratories which serve as a model in Biorisk management.
52 H I V- N AT ANNUAL REPORT 2 0 1 2 COLLEGE OF AMERICAN PATHOLOGISTS
H I V- N AT ANNUAL REPORT 2 0 1 2 53 THE VACCINE AND CELLULAR IMMUNOLOGY LABORATORY (VCI Lab) Chulalongkorn University Medical Research Centre (Chula-MRC) and Chula Vaccine Research Center (Chula-VRC)
Te VC eam (Let to Right) Arun Buaklin (Research Assistant), Pattarawat Tantiworasit (Research Assistant), Pinya Pulsawat (Research Assistant), Montalee Teeraapisakkun (Research Assistant), Sunee Sirivichayakul (Ph.D, Medical echnologist and Head o VCI Laboratory), Supranee Buranapraditkun (Medical echnologist), Patrawadee Pitakpolrat (Research Assistant), Suwanna Mekprasan (Research Assistant), Mongkol Pongsuchart (M.Sc student) Missing: Chutitorn Ketloy, Ph.D., Instructor Akachai Prompet (Ph.D. student) Kaj Chokechai-u-saha (Ph.D. student)
RESEARCH PROjECTS
1. Construction o Asian Mosaic Subtype AE/B envelope HIV DNA Vaccine and immunogenicity testing in Balb/C mice
Te mosaic subtype AE/B envelope HIV DNA has expressed by in vitro protein transection. Te in vivo been designed rom 113 CRF01_AE and 59 clade immunogenicity testing in Balb/C mice showed that B as 3 mosaic clones, i.e., mosaic 1, mosaic 2 and the constructs were immunogenic and could induce mosaic 3, respectively. Te subtype AE/B envelope both cell-mediated (by ELISpot assay) and humoral HIV DNA constructs were successully cloned into (anti-gp120/160 and anti-gp41) immune responses pCMVkan and have been proven to be well as well as a low neutralizing antibody titer.
54 H I V- N AT ANNUAL REPORT 2 0 1 2 2. Dengue prime-boost vaccination strategy combining the electroporation-delivered tetravalent DNA vaccines with live attenuated vaccines in mice and non-human primate
In order to prevent dengue inection, various Here, we asked whether in vivo electroporation vaccine approaches have been developed and no o prime-boost vaccination, combining the two approved vaccine is currently available or clinical use. types o candidates, tetravalent live attenuated Although the most progressive vaccine development vaccine (LAV) with tetravalent DNA vaccine (DNA) is live attenuated virus-based vaccine (LAV), it can would increase the immunogenicity o our dengue potentially promote collateral side efects due to a DNA vaccine. We plan to conduct this project into combination o inectious viruses. A DNA-based two phases. Te rst phase (rst year) will be used vaccine encoding specic dengue sequences is an to proo the concept o prime-boost vaccination alternative strategy as it is noninectious, however strategy in mice. I the high titers neutralizing their ecacy needs improving. In this project, several antibody is observed, the second phase (second methods are proposed to enhance the DNA-based and third year) will be urther evaluated in non- vaccine immunogenicity that have been developed human primate (rhesus macaque). in Phase I study (sup-ported by BIOEC) including: using in vivo electroporation or DNA delivery and Status: Currently, the dose titration study o LAV using prime-boost vaccination strategy by combining are evaluating in mice. DNA vaccine with LAV. Recently, there are two Collaborators/sites: Department o Microbiology, studies demonstrated that prime-boost vaccinations Faculty o Medicine, Chiangmai University o DNA vaccine with LAV or inective viruses are able to induce higher antibody levels. However, no Funding: Te National Center or Genetic study reported the efect o LAVs prime and DNA Engineering and Biotechnology (BIOEC), Tailand vaccine boost.
Publications: 1. Nguyen HL, Ruxrungtham K , Delaugerre C. 4. Wangrattanasopon P, Ruxrungtham K , Genetic barrier to the development o resistance to Chantaphakul H, Buranapraditkun S, Klaew- integrase inhibitors in HIV-1 subtypes CRF01_AE songkram J. Alkali-treated penicillin G solution is and B. Intervirology 2012; 55 : 287-295. a better option than penicillin G as an alternative 2. Le Nguyen H, Pitakpolrat P, Sirivichayakul S, source o minor determinants or penicillin skin Delaugerre C, Ruxrungtham K. Minority HIV-1 test. Allergy Asthma Proc 2012; 33 : 152-159. resistant variants in recent inection and in patients 5. anvarasethee B, Buranapraditkun S, Klaew- who ailed rst-line antiretroviral therapy with no songkram J. Te potential o using enzyme- detectable resistance-associatd mutations in linked immunospot to diagnose Cephalosporin- Tailand. J Med Virol 2012; 84 : 713-720. induced maculopapular exanthems. Acta 3. Rutvisuttinunt W, Sirivichayakul S, Oota S, Derm Venereol 2012; [Epub ahed o print]. Assawadarachai V, Poltavee K, Savadsuk H, Pattanachaiwit S, Chaemchuen S, Arroyo MA, Paris RM, Michael NL, Kim JH, Ruxrungtham K , Souza MD, Phanuphak P, ovanabutra S. wo unique recombinant orms identied in incident HIV type 1 inections in Tai blood donors. AIDS Res Hum Retroviruses 2012; [Epub ahed o print].
H I V- N AT ANNUAL REPORT 2 0 1 2 55 Education and dEVELoPmEnt Program
Education and training Program 2012
1. For Sta 1.1 Advanced GCP and HSP training course or 84 attendees on 3-4 May 2012 1.2 HIV Medicine or sta training: Te training was held on 5 July 2012. It was attended by 71 participants, including sta rom ollowing units and organizations under the Tai Red Cross Society:
• National Blood Centre • Tai Red Cross Youth • Tai Red Cross Eye Bank • Relie and Public Health Bureau • First Aid and Home Health Care raining Center • Red Cross College o Nursing • Administration Oce Up to 5 nurses rom Army Nursing College also attended the HIV Medicine or sta training. 1.3 Special meeting; Lie empowering monthly meeting by Landmark graduate sta: Te big lie empowering event on 23 March 2012 was attended by 145 sta. Monthly meetings were attended by 45-50 sta. 1.4 Special lecture; 6 clinical trial short courses training by the MD team were held rom 22 March – 10 May 2012. Up to 45 sta attended the courses
56 H I V- N AT ANNUAL REPORT 2 0 1 2 2. For Physicians and Medical Personnel in Tailand and South East Asia
• HIV-NA Symposium Series: HIV-NA provides in-depth training as a series o workshops or health care proessionals: physicians, nurses, pharmacists, scientists and others health care providers who are interested in the care o HIV inected patients. Workshop participants will be able to diagnose and give appropriate and proper care to HIV-inected patients.
In 2012, HIV-NA organized a workshop on the topic o liver disease. Te ‘HIV and Hepatic Diseases workshop’ was held on February 27-28, 2012 at Chulalongkorn Hospital and conducted entirely in Tai. Up to 100 participants rom 40 hospitals in Tailand attended.
• HIV-NA/Gilead Medical Education Program in Asia took place rom October 2011 to May 2012. Te objectives are to improve the HIV care in Asia by educating and mentor key healthcare providers and key PLHIV volunteers in Asian countries with less experience in HIV care and create a network o HIV experts in the Region that can urther cross-consult, share experience and collaborate in advocacy activities and research. Participants were HIV physicians rom 9 countries: Myanmar, Laos, Vietnam, Cambodia, Indonesia, Philippines, Pakistan, Sri Lanka and Nepal. Te rst course, Pediatric HIV and Co-inection which was held on 19-21 October 2011 was a success. Te topics and numbers o participants or the 4 ollowing courses are as ollows:
Course 2: Main course; Update on HIV Medicine 66 participants Date: 9-20 January 2012
Course 3: reatment Failure & HIV Drug Resistance 39 participants Date: 13-15 February 2012
Course 4: HIV and Hepatic Disease 40 participants Date: 26-28 March 2012
Course 5: Update on PMC 32 participants Date: 14-16 May 2012
trainings
Te Tai Red Cross College o Nursing raining Course: HIV/AIDS, B and Care September 3, 2012
Survival analysis in Pharmacoepidemiology. Graduate programme in Social and Administrative Pharmacy, Department o Pharmaceutical Sciences, Chulalongkorn University, Bangkok. Tailand. August-September 2012
1. “Neurocognitive outcomes rom the PREDIC study” at Tink ank on Neurocogitive Research Priorities or children and adolescents with HIV organized by REA ASIA on 20 February 2012 2. “Update management o pediatric HIV” organized by Bureau o AIDS, B and SIs Ministry o Public Health 8 March 2012, Bangkok, Tailand 3. “HBV prevention and care in HIV-inected children: results rom recent research”. at a Research Agenda or Diagnosis, Prevention and reatment o HIV, HBV, and HPV Inections in Southeast Asia”, organized by PHP 14-15 March, Chiang Mai, Tailand 4. “PMC in Tailand; Role o LPV/r or HIV mother to child transmission prevention” at the HIV/AIDS Expert meeting organized by the Indonesia Association o Physicians in AIDS Care (PDPAI), on 12 May 2012, Jakarta, Indonesia 5. “How to manage treatment ailure without genotyping” Workshop on diagnosis and management o pediatric antiretroviral therapy ailure organized by REA ASIA on 3 July 2012, Phnom Penh, Cambodia
H I V- N AT ANNUAL REPORT 2 0 1 2 57 studEnt suPErVision HiV-nat 2012
Supervisor Anchalee Avihingsanon Tanaporn Wattanakul Masters student at Chulalongkorn University Population Pharmacokinetics o Nevirapine in HIV-inected patients Supervisors Anchalee Avihingsanon and Jintanat Ananworanich Tep Chalermchai, SEARCH Physician PhD candidate at Chulalongkorn University Risk Factors or Chronic Hepatitis in HIV-Inected, Tai individuals without Hepatitis B or C Virus Co-Inection Supervisors Jintanat Ananworanich and Anchalee Avihingsanon Akapirat Siriwat, AFRIMS Laboratory echnologist PhD candidate at Mahidol University Establishment o Anti-HIV-1 Neutralizing Human Monoclonal Antibodies (NhMAbs) rom Tai HIV-1-inected Individuals Co-supervisors: Stephen Kerr, Jintanat Ananworanich (Primary supervisors Anthony Kelleher, David Cooper) Denise Hsu, HIV-NA Physician PhD candidate at the University o New South Wales Antigen specic CD4 immune responses in chronic HIV inection Supervisor Jintanat Ananworanich (Primary supervisors Anthony Kelleher, David Cooper) Sasiwimol Ubolyam, HIV-NA Laboratory Manager PhD candidate at the University o New South Wales Specic immune response pattern in persons with active tuberculosis beore and ater receiving anti-tuberculous therapy Supervisor Tanyawee Puthanakit Neda Esmailzadeh Medical student at University o Copenhagen, Denmark Prevalence o insulin resistance among HIV-inected children receiving lopinavir/ritonavir
58 H I V- N AT ANNUAL REPORT 2 0 1 2 Supervisor Tanyawee Puthanakit Piyada Udomchaisakul Pediatric resident at Faculty o Medicine, Chulalongkorn University Association o SCLO1B1 polymorphism and plasma concentration o lopinavir in HIV-inected children Supervisor Tanyawee Puthanakit, orsak Bunupuradah Passorn Bunyahotara Pediatric Inectious Disease Fellow at Faculty o Medicine, Chulalongkorn University Pharmacokinetics o Abacavir once daily vs. twice daily and Lamivudine once daily vs. twice daily in HIV-inected Tai Children Supervisor Praphan Phanuphak, omoki Naoe, Wataru Sugiura orsak Bunupuradah, HIV-NA Physician PhD candidate at Nagoya University Graduate School o Medicine Association o APOBEC3G genotypes and CD4 decline in Tai and Cambodian HIV-inected children with moderate immune deciency, 2011 - 2015 Supervisors Joep Lange, Praphan Phanuphak, David Burger, Jintanat Ananworanich, Ferdinand Wit, Janneke van de Wijgert Reshmie Ramautarsing, HIV-NA Physician PhD candidate at the University o Amsterdam Optimizing long term care or HIV-inected patients in Tailand, 2009 – 2013 Supervisor Joep Lange, Joel Palesky and Jintanat Ananworanich Nittaya Phanuphak, SEARCH and Tai Red Cross – AIDS Research Centre Physician PhD candidate at the University o Amsterdam Promoting early detection o HIV and anal dysplasia in Tai men who have sex with men, 2009 – 2013 Supervisor Joep Lange and Jintanat Ananworanich Nadia Kancheva Landolt, HIV-NA Physician PhD candidate at the University o Amsterdam Optimization o reproductive health care or HIV-positive women, 2009-2013 Supervisor Jintanat Ananworanich Megan Rux, High school student, Chicago Learning about HIV in children Supervisors Jintanat Ananworanich and Tanyawee Puthanakit Lindsay Anne Stevens, MD Pediatric resident at Stanord University Pediatric HIV and inectious diseases clinics observation Supervisors Jintanat Ananworanich and Tanyawee Puthanakit Midori J.Seppa, MD Pediatric resident Stanord University Pediatric HIV and inectious diseases clinics observation Supervisor Jintanat Ananworanich, Victor Valcour and Serena Spudich Idil Kore, Medical Student Yale School o Medicine Neuropsychological prole in Tai patients with acute HIV inection Supervisor Jintanat Ananworanich Co supervisor James Fletcher Annirudh Balachandran, Medical student uts University School o Medicine HIV clinic observation Supervisors Jintanat Ananworanich, Anchalee Avihingsanon Co Supervisor Reshmie Ramautarsing ara Mackay, Medical Student University o Amsterdam HIV clinic observation HPV in HIV-inected adolescents Supervisor Jintanat Ananworanich Co Supervisor Reshmie Ramautarsing Bas Bindels University o Amsterdam Literature research
H I V- N AT ANNUAL REPORT 2 0 1 2 59 15tH bangkok intErnationaL sYmPosium on HiV mEdicinE 18- 20 JanuarY 2012 he Qee s nl cve cee, b, Tl
The Bangkok International Symposium on HIV Medicine is the largest HIV meeting in Asia attended by more than 700 participants each year from Asia Pacific, Europe and the Americas. Its speakers are well known experts in various fields from Thailand, Asia, Australia, Europe and the USA. This is HIV-NAT’s 15-year, strong commitment to continuously provide health care professionals a comprehensive review and up-to-date information on HIV medicine management for the Asia-Pacific region at the Queen Sirikit National Convention Centre every January for a total of three days. Several plenary sessions are focused on selected hot topics and conducted in the morning whereas the interactive workshops with electronic e-voting machines are carried out in the afternoon. The most engrossing session is ‘the great debate’ in which provocative issues concerning HIV management are articulated to elicit strong reactions and opinions from the participants.
A year later, the ollow-up results o the Berlin Patient was reported in the Workshop on HIV and Hepatitis Virus Drug Resistance and Curative Strategies held in Sitges, Spain and this urther propelled the HIV eradication eld in to the spotlight.
As or the HIV acute, this is relatively a new eld o study as it is very di cult to nd subjects recently inected. Subjects with negative antibody tests are enrolled in to the study and then ollowed over time until they become inected. Aside rom the known data on CD4 depletion and elevation o viral load, it was discovered in 2004 that the gut CD4 memory cells were also important and were signicantly destroyed within the rst ew days o inection. Primary HIV Te topics ranged rom prevention, vaccines, acute inected subjects can also exhibit the same clinical HIV inection, antiretroviral therapy (AR), treatment maniestations as those with AIDS such as oral candida complications in adults and the pediatric population, and maculopapular rash on the hand and soles o the resistance, aging, pharmacokinetics/pharmacogenomics, eet, mimicking syphilis. Even nonspecic symptoms HIV eradication, hepatitis and tuberculosis. Tis is can occur making it di cult to sometimes diagnose the rst time that HIV eradication and HIV acute are the subjects. reatment recommendations vary accor- presented at the Symposium. For the past ew years, ding to the dierent treatment guidelines available ater several disappointing HIV vaccine results, the idea worldwide as many groups are unsure as what to do or HIV eradication was abandoned until the Tai Phase with this group o subjects. In the SPARAC rando- III HIV Vaccine Clinical rial – RV144 reported at a mized clinical trial, it was shown that there were no press conerence o having a vaccine e cacy o 26.4%. dierences in the CD4 levels between the short course Updated inormation rom the RV 144 study was also 12 weeks versus the ‘no treatment group’. Te reasons presented at Friday’s plenary entitled, “HIV vaccine: provided or treating PHI subjects are: 1. Preserve New data rom RV144 and the way orward”. HIV specic CD4 cells, 2. Prevent HIV transmission In additional, around the same time, the results rom to other people since the viral load at this time will be the CAPRISA 004 Phase IIb microbicide trial o 1% extremely high, and 3. Able to reduce latent reservoir tenoovir (DF) gel announced at the XVIIIth Interna- so unctional cure or sterilizing cure is possible. One tional AIDS Conerence in Vienna, Italy that it was able o the studies mentioned is the RV254 by Dr. Jintanat to reduce HIV incidence by 39% among women rom Ananworanich and the US Military HIV Research Pro- the DF group. Both announcements energetically gram. Tis study is examining the use o megaHAAR’s renewed the eorts in the eld o HIV eradication. (5 drugs) vs HAAR’s (3 drugs) on latent reservoir in
60 H I V- N AT ANNUAL REPORT 2 0 1 2 various compartments. By treating PHI subjects, misdiag- Ater the advantages and disadvantages were vigor- nosis, numerous medical visits, rapid progression and ously presented rom both sides, there was a 10% HIV transmission to others can be avoided. increase or the ‘no’ team unlike the ‘yes’ team which was hal o that. More than hal o the audience were Other topics commonly requested by participants on swayed by the notion o oering PrEP to their patients a continuous basis are ‘hepatitis’ and ‘tuberculosis’ however they do not think that this should be part o as this area is epidemic or both diseases. Aside rom the standard care. As a result o this, the ‘no’ team those topics, lectures on dierent AR strategies won the argument eortlessly. such as when to start and what to start, what kind o care is needed or those who do not need AR, how Tis is just a brie glimpse into the Symposium. Since to optimize treatment, how to deal with long-term there are so much going on, the best way to get all o complications and resistance as well as new ARVs in the inormation is to attend the symposium. Not all the pipeline were presented. Innovative strategies in sessions can be brieed in the “Conerence Scene”. sustaining HIV health care programs amidst economic troubles worldwide were provided which Tailand is For more inormation, you can go to the Conerence starting to use. In August 2012, the Tai government Scene published in Future Virology, April 2012, Vol. 7, announced that the excise taxes or alcohol and ciga- No. 4, Pages 341-344 (http://www.uturemedicine. rettes would be increased. For example, white spirits com/toc/vl/7/4) or download the slides and/or watch was increased up to 150 baht per liter i the alcohol the webcasts or ree at www.hivnat.org. Some slides content was 100% which was an increase o only 30 are not provided as per speakers’ request. baht. For blended spirits, the tax was increased to 350 baht per liter i the alcohol content was 100%. As or cigarettes, the taxes were increased by 2%, rom 85% up to 87%. e next Symposium has topics that are just as riveting as this one! Along the same lines as last year’s debate topic, the question addressed whether PrEP should be used or It will be held on January 16-18, HIV prevention or not among MSMs. Initially, beore 2013 at the Queen Sirikit Convention the debate, 42.2% were ‘against’ oering PrEP to Centre in Bangkok, ailand. MSM as part o the standard HIV prevention program whereas 34.4% were ‘or’ and 22.2% were ‘undecided’.
H I V- N AT ANNUAL REPORT 2 0 1 2 61 PartnErsHiP
Te Ministry o Public Health, Tailand provides:
● policy direction through membership o the HIV-NA international advisory board ● approval or the importation o study materials ● assistance with the provision o study medications
tHE Foundation For aids rEsEarcH (amFar) EstabLisHmEnt oF tHE amFar oFFicE in bangkok, tHaiLand
Te amAR oce in Tailand was established with the successul completion o the application to the Ministry o Labor in April o 2006. As reported in the application, this oce is intended to support the regional eorts o the REA Asia (Terapeutics Research, Education and AIDS raining in Asia) program (http://www.amar.org/ treatasia). Te program was originally launched in July 2001 and is intended to provide support or the sae and eective delivery o HIV treatments in Asia. Te program is currently supporting projects in 14 countries and economies in the Asia-Pacic including Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, aiwan, Tailand and Viet Nam. Te projects ocus on our primary objectives: research, education and training, public policy, and strengthening civil society through treatment education. Te program currently employs 18 sta members.
AHOD: Te REA Asia HIV Observational Database (AHOD) is a collaborative observational cohort study, which involves 21 participating sites in the Asia-Pacic, including HIV-NA/Tai Red Cross (Bangkok), Ramathibodi Hospital (Bangkok) and Chiang Mai University - Research Institute or Health Science (Chiang Mai). Te primary objectives o AHOD are to: 1. Develop capacity in HIV clinical data collection in countries o the Asia-Pacic region; 2. Assist in evaluation o new HIV treatments or the Asia-Pacic region; 3. Monitor antiretroviral and prophylactic treatment; 4. Monitor toxicity to antiretroviral therapy; and 5. Examine HIV natural history, including the relationship between access to antiretroviral therapy and disease progression.
Te project was established in 2003 and has enrolled ~8,000 patients. Sub-studies within the adult program have allowed or more in-depth research on specic topics (e.g., renal unction, tuberculosis). Te program is supported in part by a grant rom the US National Institutes o Health.
AHOD Publications are as ollows: 1. Zhou J, et al. J Acquir Immune Dec Syndr. 17. Han SH, et al. Endocr J. 2011 Apr 27. December 2006; 43(4): 501-503. 18. Zhou J, anuma J, Chaiwarith R, Lee CK, Law MG, 2. Zhou J, at el. Antiviral Terapy 2007;12(Suppl.2):L45 Kumarasamy N, Phanuphak P, Chen YM, Kierti- 3. Zhou J, et al. Clin Inect Dis. January 2007;44(1): buranakul S, Zhang F, Vonthanak S, Ditangco R, 147-149 Pujari S, Choi JY, Parwati Merati , Yunihastuti E, 4. Zhou J, et al. HIV Medicine. January 2007;1(8): 8–16. Li PC, Kamarulzaman A, Nguyen VK, Tuy Pham , 5. Zhou J, et al. Int J SD AIDS. 2007 Jul;18(7): 446-52. Lim PL. Loss to Followup in HIV-Inected Patients 6. Huam SE, et al. HIV Med. August 2007, 8(7): rom Asia-Pacic Region: Results rom AHOD. 465-471. AIDS Research and reatment 2012; 2012: 7. Srasuebkul P, et al. AIDS Research and Terapy. 375217. September 2007, 4:18. 19. Lim PL, Zhou J, Ditangco RA, Law MG, Sirisanthana 8. Zhou J, et al. J Gastroenterol Hepatol. September , Kumarasamy N, Chen YMA, Phanuphak P, Lee 2007, 22(9): 1510- 1518. CKC, Saphonn V, Oka S, Zhang F, Choi JY, Pujari S, 9. Zhou J, et al. BMC Inect Dis. 2009 Apr 21;9:46. Kamarulzaman A, Li PCK, Merati P, Yunihastuti E, 10. Srasuebkul P, et al. Clin Inect Dis. 2009 Apr 1;48 Messerschmidt L, Sungkanuparph S and REA (7):940-50. Asia HIV Observational Database (AHOD). Failure 11. Pujari S,et al. J Antivir Antiretrovir. 2009 Nov to prescribe pneumocystis prophylaxis is associated 1;1(1):28-35 with increased mortality, even in the cAR era: 12. Zhou J, et al. HIV Medicine 2010 Jan.11(1):31-39 results rom the reat Asia HIV Observational 13. Oyomopito R, et al. HIV Med. 2010 Sep;11(8):519-29. Database. Journal o the International AIDS 14. Achhra AC, et al. AIDS Clin Res. 2010 Oct 8;1(1):1-4 Society 2012, 15:1 doi:10.1186/1758-2652-15-1 15. Zhou J, et al. BMC Inect Dis. 2010 Dec 23;10:361 16. Petoumenos K, et al. J Int AIDS Soc. 2010 Dec 10;13:51
62 H I V- N AT ANNUAL REPORT 2 0 1 2 AHOD presentations are as ollows: 1. AIDS dening illness diagnosed within 90 days ater 13. Short-erm Clinical Disease Progression in HIV-1- starting HAAR among AHOD patients. Presented Positive Patients aking Combination. Presented at the 3th IAS Conerence on HIV Pathogenesis and at the 20th Annual Australasian Society or HIV reatment, Rio de Janeiro, Brazil, 24-27 July 2005 Medicine (ASHM) Conerence, Perth, Australia, 2. Experience with the use o a rst-line regimen o 17-20 September 2008 stavudine, lamivudine and nevirapine among AHOD 14. Patient characteristics and treatment outcomes patients. Presented at the 17th ASHM Conerence, associated with protease inhibitor (PI) use in Hobart, Australia, 24 – 27 August 2005 the Asia-Pacic region [Abstract #: P_72] 3. Dierence between Asian and Caucasian HIV-inected Presented at the 9th International Congress on patients in absolute CD4 count and CD4 percentage. Drug Terapy in HIV Inection, Glasgow, UK, 9–13 Presented at the 10th International Workshop on November 2008 HIV Observational Databases, Madrid, Spain, March 15. Short-term risk o anemia ollowing initiation o 23-26, 2006 and XVI International AIDS Conerence. antiretroviral treatment in HIV-inected patients oronto, Canada 13-18 August 2006 in countries rom sub-Saharan Arica and Asia. 4. Risk o active tuberculosis (B) and prognostic Presented at the 14th International Workshop on signicance o tuberculosis among AHOD patients. HIV Observational Databases, Lisbon, Portugal, Presented at the 10th International Workshop on 25th – 27th March 2009 HIV Observational Databases, Madrid, Spain, March 16. Short-term risk o anemia ollowing initiation o 23-26, 2006 and XVI International AIDS Conerence. antiretroviral treatment in HIV-inected patients oronto, Canada 13-18 August 2006 in countries rom sub-Saharan Arica and Asia. 5. Parametric models o immunological ailure in HIV- [Abstract #: 200721711] Presented at the 5th inected Tais receiving antiretrovirals at HIV-NA International AIDS Society Conerence, Cape own, and validation using the AHOD. Presented at the Arica, 19-22 July 2009 18th Annual Conerence o the Australasian Society 17. Prevalence and Risk Factors o Lipodystrophy or HIV Medicine. Melbourne, Australia, 11 to 14 among HIVinected Persons Receiving HAAR in October 2006 the Asia-Pacic Region: Results rom the REA 6. Experience Using AZ and d4 in AHOD Patients: Asia HIV Observational Database. [Abstract #: reatment Duration and AZ Related Anaemia. H1576] presented at the 49th Interscience Presented at the 14th CROI, Los Angeles, USA, Feb Conerence on Antimicrobial Agents and Chemo- 25-28, 2007 therapy (ICAAC), San Francisco, Caliornia, USA, 7. Data Collection or Antiretroviral reatment Related 16-18 September 2009 Adverse Events (AEs) in Te REA Asia Observa- 18. Non-virological criteria to predict virological ailure tional in AHOD and IeDEA SA. Presented at the IeDEA 8. Database. Presented at the 11th International Satellite Meeting, San Francisco, USA, 20 February workshop on HIV Observational Databases, Monte 2010 Carlo, 22-25 March 2007 19. rend o CD4 cell count in HIV-inected patients 9. Antiretroviral reatment Related Adverse Events with HIV viral load monitoring while on combination (AEs) in Te REA Asia HIV Observational Data- antiretroviral treatment. Presented at the Te base. Presented at the 9th International Workshop 14th International Workshop on HIV Observational on Adverse Drug Reactions and Lipodystrophy in Databases, Sitges, Spain, 5-27 March 2010 HIV, Sydney, 19–21st July 2007 20. Impact o sex on long-term treatment outcomes o 10. Measures o country-specic resourcing predict highly active antiretroviral therapy (HAAR) in the virologic suppression, immunologic response REA Asia HIV Observational Database [Abstract and disease progression in the REA. Presented #: 200736571] presented at the International by the 12th International Workshop on HIV AIDS Society Conerence 2010, Vienna, Austria, Observational Databases, Malaga, Spain, 28 March 18-23 July 2010 2008 and 20th Annual Australasian Society or 21. Impact o Hepatitis B Virus (HBV) and Hepatitis C HIV Medicine (ASHM) Conerence, Perth, 17-20 Virus (HCV) Co-inections on Immunological September 2008 Responses to HAAR in the REA Asia HIV 11. Deerred modication o antiretroviral regimen Observational Database (AHOD) [Abstract #: ollowing treatment ailure in Asia: Results rom 200739465] presented at the International AIDS Te REA Asia HIV Observational Database Society Conerence 2010, Vienna, Austria, 18-23 (AHOD). [Poster#: UPE0116] Presented at the July 2010 17th International AIDS Conerence, Mexico City, 22. High Prevalence o Anal Squamous Intraepithelial Mexico, 3-8 August 2008 Lesions in HIV-positive and HIV-negative Men who 12. HIV Disease Progression In HIV-1 Patients have sex with Men in Tailand presented at the Initiating Combination Antiretroviral Terapy With International AIDS Society Conerence (IAS) 2010, Advanced Disease In Te Asia-Pacic Region: Vienna, Austria, 18-23 July 2010 Results From Te REA Asia HIV Observational 23. Lack o prophylaxis against Pneumocystis pneu- Database (AHOD). Presented at the 20th Annual monia and mortality: Results rom the REA Asia Australasian Society or HIV Medicine (ASHM) HIV Observational Database (AHOD) [Abstract #: Conerence, Perth, Australia, 17-20 September H213] presented at the Interscience Conerence on 2008 Antimicrobial Agents and Chemotherapy (ICAAC), Boston, USA, 12-15 September 2010
H I V- N AT ANNUAL REPORT 2 0 1 2 63 ASER: Te REA Asia Studies to Evaluate Resis- Chaiwatanarat , Nakavachara P, Maleesatharn A, tance (ASER) was a program to evaluate HIV drug Chokephaibulkit K. Prevalence and risk actors o low resistance within REA Asia clinical centers and to bone mineral density among perinatally HIV-inected build capacity or HIV resistance testing (genotyping), Tai adolescents receiving antiretroviral therapy. J surveillance o transmission o ARV-resistant HIV, Acquir Immune Dec Syndr. 2012 Aug 22. and monitoring the emergence o resistance among 6. Aurpibul L, Lumbiganon P, Kolasaraksa P, Hansude- those taking ARV therapy. Te study included 16 wechakul R, Sa-Nguanmoo P, aeprasert P, Bunupu- participating sites in ve countries in Asia, including radah , Pooworawan Y, Sirisanthana V, Puthanakit HIV-NA/Tai Red Cross (Bangkok), Ramathibodi . HIV and HBV co-inection among perinatally Hospital (Bangkok), Siriraj Hospital (Bangkok), Chiang HIV-inected adolescents in Tailand. Pediatr Inect Rai University and Chiang Mai University. Te study is Dis J. 2012 May 15. now closed, but data analyses are ongoing. Data rom 7. Puthanakit , Bunupuradah , Kosalaraksa P, Vibol ASER have been merged into AHOD. U, Hansudewechakul R, Ubolyam S, Suwanlerk , Kanjanavanit S, Ngampiyaskul C, Wongsawat J, AQAS: the REA Asia Quality Assurance Scheme Luesomboon W, Vonthanak S, Ananworanich J, (AQAS) was designed to build capacity and establish Ruxrungtham K. Prevalence o HLA-B*5701 among external quality assurance or HIV Drug resistance HIV-Inected Children in Tailand and Cambodia: testing. AQAS was developed as a parallel program to Implications or Abacavir Use. Pediatr Inect Dis J. ASER. Prociency panels include HIV samples derived 2012 Sep 17. rom HIV-1 subtype B and non-B isolates. AQAS was rst implemented in April 2006, and now continues ApHOD presentations are as ollows: through a program included sponsored and non-spon- 1. Regional survey o HIV clinical care resources and sored laboratories. Currently, there are 15 participa- management practices in the REA Asia pediatric ting sites rom 6 countries in the Asia-Pacic region, 2. Program. Presented at the Australasian Society including three laboratories in Tailand: Chulalongkorn or Inectious Diseases (ASID) Annual Scientic University (Bangkok), Siriraj Hospital (Bangkok) and Conerence, New South Wales, Australia, 25-28 Chiang Mai University (Chiang Mai). March 2009 3. Antiretroviral Terapy Outcomes in HIV-positive ApHOD: Te REA Asia Pediatric HIV Observational Children in Asia: Data rom the REA Asia Pediatric Database (ApHOD) is a collaborative observational HIV Observational Database. Presented at the 5th cohort study, which involves 16 participating sites IAS Conerence on HIV Pathogenesis, reatment in six countries in the Asia-Pacic region including and Prevention, 19-22 July 2009, Cape own, South HIV-NA/Tai Red Cross (Bangkok), Siriraj Hospital Arica. (Bangkok), Chiang Mai University - Research Institute 4. Impact o antiretroviral therapy on opportunistic or Health Science (Chiang Mai), Chiang Rai Regional inections o HIV-inected children in the REA Asia Hospital (Chiang Rai) and Khon Kaen University (Khon Pediatric HIV Observational Database Presented at Kaen). Te primary objectives o ApHOD are to: the Presented at the International Workshop on HIV Pediatrics, Cape own, Arica, 19-22 July 2009 1. Develop capacity in HIV clinical data collection in the 5. Antiretroviral Terapy Outcomes in HIV-positive Asia-Pacic region; Children in Asia: Data rom the REA Asia Pediatric 2. Assist in evaluation o new pediatric HIV treatments HIV Observational Database. [Poster #: MOPEB085] or the Asia-Pacic region; Presented at the International Workshop on HIV 3. Monitor antiretroviral and prophylactic treatment; Pediatrics, Cape own, Arica, 19-22 July 2009 4. Monitor toxicity to antiretroviral therapy; and 6. Survival and Risk Factors associated with Mortality 5. Examine HIV natural history in children, including the o HIVInected Children: A Cohort rom the Asia- relationship between access to antiretroviral therapy and disease progression. Pacic Region. [Poster #: H-927] Presented at the Interscience Conerence on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, CA, USA, Te project was established in 2006 and has enrolled 12-15 September 2009 4,400 patients into prospective ollow-up. Sub-studies 7. Antiretroviral Terapy Outcomes in HIV-positive within the pediatric program have allowed or more Children in Asia: Data rom the REA Asia Pediatric in-depth research on specic topics (e.g., bone mineral HIV Observational Database. [Poster #: MOPEB085] density, hepatitis B). Te program is supported in part Presented at the Australasian Society or HIV Medi- by a grant rom the U.S. National Institutes o Health cine (ASHM), Cape own, Arica, 19-22 July 2009 and the Austrian AIDS Lie Association. 8. Severe adverse events in HIV-inected children in Asia ater rst-line HAAR. [Poster #: O13] ApHOD publications are as ollows: Presented at the 2nd International Workshop on HIV 1. Prasitsuebsai W, et al. AIDS Patient Care SDS. Pediatrics, Vienna, Austria, 16–17 July 2010 2010 Feb;24(2):127-31. 9. High prevalence o low bone mineral density among 2. Hansudewechakul R, et al. J Acquir Immune Dec perinatally HIV-inected Tai adolescents receiving Syndr. 2010 Dec;55(4):503-9. antiretroviral therapy. [Poster # P_7] presented at 3. Kariminia A, et al. Int J Epidemiol. 2011 the 3rd International Workshop on HIV Pediatrics. Feb;40(1):15-24. Rome, Italy, 15 - 16 July 2011 4. Lumbiganon P, et al. J Acquir Immune Dec Syndr. 10. Second-line highly active antiretroviral therapy in 2011 Apr;56(4):365-71 Asian HIV-inected children. [Poster # P_37] 5. Puthanakit , Saksawad R, Bunupuradah , presented at the 3rd International Workshop on Wittawatmongkol O, Chuanjaroen , Ubolyam S, HIV Pediatrics. Rome, Italy, 15 - 16 July 2011
64 H I V- N AT ANNUAL REPORT 2 0 1 2 Education and training Education Program or Building Research Capacity REA Asia implemented a research capacity-building education program with support rom the Australian Agency or International Development (AusAID) in 2008. When that program ended in 2011, subsequent training programs have ocused on clinical care or children and men who have sex with men, and developing regional research capacity.
PoLicY and communications Te REA Asia Report includes reviews o current research activities in the REA Asia network and elsewhere in the Asia-Pacic. Te report has eatured interviews with leading regional and global gures in AIDS treatment, research, and policy. It is produced three times a year as part o REA Asia’s communications activities. strEngtHEning ciViL sociEtY o strengthen civil society and community involvement in HIV/AIDS programs in the Asia-Pacic region, REA Asia supports activities to provide HIV treatment literacy training, and promote community advocacy or access to optimal HIV treatment regimens. REA Asia also supports the Adam’s Love website, and the development o a parallel website and social media project in Indonesia, called eman eman.
gLobaL Fund to FigHt aids, tubErcuLosis and maLaria Tis program started in 2006 with the aim to use the Global Fund money to buy antiretroviral therapy and monitoring assays or monitoring CD4 and viral load or patients post clinical trials. HARR has been shown to eectively reduce HIV related illnesses and mortalities, improving our patients’ quality o lives signicantly. Besides providing ARV therapy to patients, we also collect long term data rom each patient participating in the study. ARV drugs, CD4 and viral load tests are supported by Global Fund. Currently, 1424 adults and 321 children receive ree ARV drugs, CD4 and viral load tests through the program. Because o the outstanding outcome o this year’s program, we are currently proposing to the Global Fund to continue the program via the rolling continuation channel.
H I V- N AT ANNUAL REPORT 2 0 1 2 65 sErVicE
Pph Phph is a member o the Tailand rehe r is a program coordinator or National AIDS Committee and the Vice-Chair o Tailand the Community[e]Education program and a trainer or Country Coordinating Mechanism (CCM) o Global Fund the HIV[e]Education program, both or the Health[e] or AIDS, uberculosis and Malaria. Foundation, Amsterdam, Te Netherlands.
k rxh is the chair o the Academic Tywee Ph is aculty member o Sub-committee on HIV reatment and Care o the Department o Pediatrics, Faculty o Medicine, National AIDS Program, National Health Security Chulalongkorn University, member o the expert panel Oce (NHSO); President o the Allergy and Immunology working group o the Tai Ministry o Public Heath HIV/ Society, Tailand (AAIA); a member o the expert panel AIDS on antiretroviral therapy practice policy guideline, working group on antiretroviral therapy practice policy a member o the WHO technical reerence group guidelines; the Chair o the Research Committee o Pediatric HIV/AR care and member o the maternal- the Royal College o Physicians, Tailand. He is also the child health guidelines development group or WHO scientic co-chair o rack A o the IAS HIV Pathogenesis 2013 consolidated antiretroviral guidelines. She served conerence will be held in Kuala Lumpur, Malaysia 2013. as a reviewer or various journals such as the Pediatric Inectious Disease Journal, BMC Pediatrics, HIV medicine. She is the lecturer or pediatric HIV/AIDS. d. J awh is an adjunct aculty member o the Department o Medicine at Chulalong- korn University, University o New South Wales and W Pe is a lecturer or local hospitals University o Amsterdam, and University o Hawaii. and international training courses in HIV, opportunistic She has served as rack B committee member or the inections and complications. 2012 IAS meeting in Washington DC and will be rack B co-chair or the upcoming 2013 IAS pathogenesis Wh me--w is a part-time lecturer at meeting in Malaysia. She is a scientic committee Division o Allergy and Clinical Immunology, Department member or the 2013 ICAAP meeting in Bangkok. o Medicine, Faculty o Medicine, Chulalongkorn She is an organizing committee member or the Inter- University, and Centre o Excellence or Biomedical national Workshop on HIV Pediatrics since 2009 and and Public Health Inormatics (BIOPHICS), Faculty o will serve as co-chair or its 2013 meeting. She is on ropical Medicine, Mahidol University. He is also an the scientic advisory committee or the Tai Govern- external examiner or knowledge and thesis deense, ment Pharmaceutical Organization. She is on the Master/Ph.D Program at Mahidol University and steering committees or the Pediatric European Chulalongkorn University, a reviewer or various journals Network or reatment o AIDS and reat Asia. She such as Journal o Pediatric Inectious Diseases, serves on the Scientic Assessment Panel o the HIV Southeast Asian Journal o ropical Medicine and Research rust Award. She is the deputy editor or Public Health and Asian Pacic Journal o Allergy and AIDS Research and Terapy, the editor or Open Immunology. Virology Journal and a reviewer or various journals such as Lancet, CID, and AIDS.
ahlee avh is a member o the expert panel working group o the Tai Ministry o Public Heath HIV/AIDS management guidelines, a member o the committee o Tai AIDS Society, a member o the expert panel working group on antiretroviral therapy practice policy guidelines, a member o the Tai Royal College o Physicians, an external reviewer or Qualiy Ph.D Examination, a member o the working committee on implementing antiretroviral therapy into the universal health care system, the AIDS Division, Ministry o Public Heath and adjunct aculty member o Chulalongkorn University, Faculty o Medicine. She is also a lecturer or local hospitals and international training courses in HIV, opportunistic inections and complications.
66 H I V- N AT ANNUAL REPORT 2 0 1 2 www.adamslove.org Adam’s Love innovatively combines education and entertainment and is the rst website o its kind in Southeast Asia. Adam’s Love oers an opportunity or MSM in Tailand to access reliable HIV/AIDS-related inormation rom the privacy o thei own homes. In addition to basic acts about HIV risk, testing, and treatment, visitors can access expert advice and online counseling while connecting with other MSM and enjoying entertainment eatures like photography and celebrity interviews. Te website’s creative team is now partnering with amAR to explore initiating a similar “edutainment” website in Indonesia. tHE tHai rEd cross aids rEsEarcH cEntrE (trc-arc) In 2012, Tai Red Cross AIDS Research Centre (RC-ARC), the mother organization o HIV-NA, had many achievements and accomplishment which build on its mission to set high standards o patient care, research and community development. Our ongoing activities are as ollows. tHE tHai rEd cross anonYmous cLinic (trc-ac) Te Tai Red Cross AIDS Research Centre’s Anonymous Clinic is the rst HIV voluntary counseling and testing clinic in Asia, established in 1991. Comprehensive health care services are provided to clients regardless o HIV status as entry points to HIV testing according to the provider initiated counseling and testing model (PIC), aiming to reduce stigma o HIV testing. Tese nutrition cLinic at tHE tHai rEd cross services include annual health checks, anal and cervical aids rEsEarcH cEntrE Pap smear, SI testing and treatment and nutritional Nutrition services including nutrition assessment assessment and counseling. and counseling are available every week days at the Anonymous Clinic. Te nutrition services are available to people living with HIV who come or ollow-up care tHE tHai rEd cross mEn WHo HaVE sEX at the Anonymous Clinic and those who come or WitH mEn (msm) sEXuaL HEaLtH cLinic health check-up. All clients are screened or nutritional Te Tai Red Cross AIDS Research Centre’s Anonymous problems by health care providers when they receive Clinic started providing sexual health services to Men any service at anonymous clinic. I they have nutrition who have Sex with Men (MSM) in 2008. Te number problems (i.e. being underweight, obesity, dyslipidemia o MSM clients receiving the services increased rapidly, or hyperglycemia), or are at risk or nutrition problems leading the Tai Red Cross AIDS Research Centre to (i.e. taking nutrition supplement, having any symptom o cially establish its “Men’s Health Clinic” in June 2009. aected by eating), they will be reerred to nutritionist or urther assessment and in-depth counseling. At the Men’s Health Clinic, Voluntary Counseling and esting (VC) service or MSM was made even more Te nutrition assessment and counseling services aim user-riendly. Staed with MSM-sensitive health care to promote general health o people living with HIV in providers, the clinic is separated rom the general VC the short term and long term through improvement service. And the patients get conrmed test results in o nutritional status. In the short term, nutrition care 3 hours. aims to prevent weight loss in newly diagnosed HIV- inection. For the long term, nutrition assessment and Te Men’s Health Clinic provides health services that counseling aim to monitor and prevent the chronic are o interest or MSM, and serves as an entry point diseases which are commonly ound in people living or HIV counseling and testing. Available services with HIV ater receiving AR treatment. include Anal PAP smear, SD screening & x, PEP and body composition measurement. Precancerous anal Up to 500 clients attended the nutrition clinic in the neoplasia (AIN II-III) was ound in 18.7% o HIV+ve rst hal o 2012. Most o which are general clients, MSM and in 8.9% o HIV-ve MSM. particularly Men who have Sex with Men (MSM), who come or health check up.
H I V- N AT ANNUAL REPORT 2 0 1 2 67 Lao-tHai-austraLian coLLaboration in Te objectives and the key ocus areas o work o the HiV-nutrition (Lao- tacHin) ProJEct: centre are: Advocacy, Capacity Building, Research, In- Ater our years implementation (since July 2008), ormation Management and Monitoring and Evaluation. Lao-ACHIN project has completed the rst phase in 1. o advocate with governments, academic institu- June 2012. Many achievements are seen either tions and civil society organizations the benet o improving nutritional status and health o PLHIV integrating nutrition interventions or improving directly or improving health service system showed the the quality o lie, health status and medical benet o integrating nutrition care into HIV service. management o PLHIV. Tis model that was initiated in two southern provinces 2. o build capacity o health care sta and civil o Lao PDR, Champasak and Savannakhet, has been society organizations to assess the nutrition issues handed-over to the Ministry o Health Lao PDR to o PLHIV and provide appropriate interventions, care expand to others provinces in Lao PDR. and support. 3. o initiate and coordinate clinical and operational With collaboration with the previous partnership, the research that includes nutrition or PLHIV and to Albion Centre (AC) and Lao partners (Center or HIV/ address the knowledge gap. AIDS and SI, Ministry o Health, Lao PDR, World Health Organisation, Lao PDR and Association o Te Tai Nutrition askorce or HIV (N-HIV) is a People living with HIV/AIDS) and the new counterpart, national HIV nutrition committee, appointed in 2008, World Food Programme, the Tai Red Cross AIDS consisted o Tai experts in HIV and nutrition rom Research Centre (RCARC) will provide support to Lao various organizations including the Tai Ministry o PDR to move orward to the second phase by providing Public Health, Institution o Nutrition, Mahidol Univer- technical assistance and seeking the unds rom donors. sity, and ACHIN. Te ollowing HIV nutrition studies are conducted under the N-HIV.
N-HIV 003 (rends o morbidity and mortality among Tai HIV-inected and HIV-uninected patients, a fve-year multi-centre, prospective cohort) Te study aims to determine the morbidity and mor- tality among Tai HIV-inected participants compared to HIV-uninected participants at the RC-ARC and the Queen Savang Vadhana Memorial Hospital during 2010 –2017. Te study has started enrolling 408 HIV-inected participants and 408 HIV-uninected participants in November 2010. Tis study has currently enrolled 230 and 237 o Tai HIV-inected participants and HIV-unin- ected participants. Among 83 and 55 o HIV-inected L-tacHin fl whp, participants and HIV-uninected participants have 7-8 Je 2012, Vee, L Pdr. already ollow up in mo 12. Te study will complete in Pro.Praphan Phanuphak, Director o RCARC (second November 2017. rom the right) and Ms.Charmaine urton, director international health unit, AC (the rst rom the right) (Bone Health and vitamin D presented the trophy o “South-South Development N-HIV 003.1 Project Award”, the award to Lao-ACHIN project rom status in Tai HIV-1 Inected and Uninected Adults the Global South-South Development Expo o the United (A substudy o N-HIV 003: rends o morbidity and Nations held in Rome, 5-9 December 2011, to Lao team mortality among Tai HIV-inected and HIV-uninected leading by Dr. Inlavan Keobounphanh, Deputy Minister patients: a fve-year prospective cohort study) o Health, Lao PDR Given the recent interest in the impact o HIV inection on bone health and vitamin D levels and the asso- ciation o low vitamin D status with several chronic diseases, this study will determine bone health and asia PaciFic coLLaboration cEntrE For vitamin D levels, both in HIV-inected population and HiV-nutrition (aPcHin): uninected population, as a sub-study o N-HIV 003. Te study has started the enrollment o 70 HIV- “Working with governments, civil society and partners uninected participants, 55 HIV-inected with high CD4 in Asia and the Pacifc to integrate nutrition into HIV and 110 HIV-inected with planned to start HAAR in programmes: November 2010. Tis study has now completed the enrollment o HIV-uninected participants and HIV- Based on the achievements o ACHIN and Lao- inected with high CD4 group. Up to 75 participants ACHIN in Asia, the Asia Pacic Collaborating Centre or 82.5% o the total participants in HIV-inected with or HIV Nutrition (APCHIN) was established since June plan to start HAAR group has currently enrolled. 2012 by three leading organizations in HIV and Nutri- Te study will be completed in November 2017. tion in Asia and the Pacic- AC, RCARC and WFP. Te centre is hosted at RC.
68 H I V- N AT ANNUAL REPORT 2 0 1 2 mom tELLs mom LoVEd; an intEgratEd Parent’s major concerns or disclosure included ears aPProacH oF HiV discLosurE For that the child would be too young to understand HIV HiV-aFFEctEd FamiLY and to keep it condential (47%), the child may be araid o getting HIV rom them (19%), and the child Tis project is a collaboration between the Italian may think o parents as bad persons (9%). Families Red Cross and the RC-ARC which aims to develop with uninected children had signicant higher willing- an HIV disclosure model or HIV-aected amilies in ness and readiness than the amilies with inected Tailand, to improve the health status communication children p( =0.03). skill within amilies, to improve the quality o lie and to strengthen the knowledge and capacity, counseling Age 31-35 years (OR=3.06, 95%CI 1.01-15.66, skill and disclosure technique o healthcare workers p=<0.01), being male (OR=5.06, 95%CI 1.55-16.50, regarding the Integrated Approaches o HIV Disclosure p=<0.01), and children’s age >17 years (OR=31.48, or HIV-aected Family. Te project has completed the 95%CI 10.71-92.57, p=<0.001) were predictors sta training or disclosure techniques by disclosure o the willingness to disclose. Age 31-35 and ≥41 experts, the survey o the readiness and actors associ- years (OR=5.33, 95%CI 1.33-21.36 and 5.18, 95%CI ated with health status communication within amilies, 1.27-27.11, respectively, p=0.02), higher education group sessions and “Healthy Camp” activities. (OR=2.26, 95%CI 1.26-4.04, p=<0.01), having ≥3 Te study will be completed in December 2012. children (OR=3.15, 95%CI 1.37-7.23, p=0.02), and children’s age >17 years (OR=2.75, 95%CI 1.47-5.14, Te data rom the survey o the readiness and actors p=<0.01) were associated with the readiness to associated with health status communication within disclose. From the survey, we can conclude that more amilies have shown that among 367 HIV-inected than hal o HIV-inected Tai parents were willing to parents (male 18.8%, women 81.2%), 0.8% already disclose their HIV status to their children. When and disclosed their HIV status to their children, 14.7% had how to disclose HIV status without creating negative not yet disclosed but were willing and ready to dis- consequences pose a major challenge. Parental HIV close, 50.4% were willing but not ready, 33.2% didn’t disclosure studies and demonstration models are want to disclose, and 0.8% didn’t respond. Children needed to provide guidance and recommendations included 59 boys and 66 girls. Mean (SD) age was in this eld. 37.5 (±5.2) years or parents, 12.0 (±3) years or HIV- inected children (n=31), and 11.5 (±4.3) years or HIV-uninected children (n=94).
Standard o Procedure (SOP) o HIV disclosure model
H I V- N AT ANNUAL REPORT 2 0 1 2 69 asian rEd cross and rEd crEscEnt In late 2011, Te AR Secretariat O ce is transerred HiV/aids nEtWork (art) to Cambodia and AR Website is also hosted by AR Secretariat O ce in Phnom Penh, Cambodia. Te Asian Red Cross & Red Crescent ask Force With the support rom the Australian Red Cross (ARC) (AR) was established in 1994 ollowing the Beijing Te ARC Volunteer had provided the training to the Decla- ration. Over the years, the name —ask Force AR Secretariat Assistant to maintain the AR website. was inormally changed to —Network. AR currently From the 25th to the 26th April 2012 in Borei Angkor has members rom 15 South East Asia and East Asia Hotel at Siem Reap province, AR Website Develop- National Societies (NS). At the beginning, the Inter- ment Workshop was successully conducted by AR national Federation o Red Cross and Red Crescent Secretariat and trained by ARC Volunteer. Te work- Societies (IFRC)’s Regional Delegation, Kuala Lumpur shop was attended 14 participants including AR served as the Secretariat, this role was transerred to the Philippines National Red Cross ollowing the deci- members rom national societies, AR Chair, HIV/AIDS program sta rom Head Quarter and AR Secretariat sion or national societies to manage the Secretariat on Assistant. Te workshop improved the capacity o a rotational basis. Te Secretariat was transerred to the AR members to post articles, reports, photos, the Tai Red Cross in 2000 or three years, then back videos and other materials related to HIV/AIDS to the IFRC at the Regional Delegation in Bangkok activities to the AR Website in order to promote and Tai Red Cross and currently is AR secretariat the AR Website among donors, government, hosted and chaired by the Cambodian Red Cross. NGOs and organizations.
AR Website Development Workshop 25-26 April, 2012 Borei Angkor & Spa, Siem Reap, Cambodia
Participants testing in login
70 H I V- N AT ANNUAL REPORT 2 0 1 2 tHai rEd cross aids rEsEarcH cEntrE PErsonnEL
administratiVE dEPatmEnt From the let side: Tanachai Ludkrood (Inormation echnology), Sumitra echapalokul (Administrative Ocer), Vijitra Pradubkaew (Chie o Administrative Department), Somchai Wutthiworakul (Administration Ocial), Songsri Wiriyawong (Administration Ocial), Nion Pakawa (Financial), Suphavadee Sangman (Financial), Somchart Takaeng (Administrative Ocer), Sukanya Kaivikaikosol (Housekeeper), Patinya Suriwong (Administrative Ocer), Sunanta Intarasuk (Administrative Ocer), Ruthairat Pruksasri (Purchasing Ocer)
anonYmous cLinic From the let side: Orawan Panichob (Receptionist), Sutthiphong Ploynage (General Service Ocer), Prapakorn Koomwan (Medical record Sta), Sureerat Ittichai (Project Coordinater), Radda Pannun (Administrative Ocer), anujit Rakphan (Psychologist), Charnwit Pakam (Administrative Ocer), Patchalee Suttapintu (Educator), Ekkapan Manmon (Project Coordinater), Siripen Areeprayunkit (Finance and Accounting Ocer)
LaboratorY From the let side: ippawan Pankam (Medical echnologist), Samanan Tongyol (Medical echnologist), Watchara Deepum (Medical echnic Assistant), Kannapat Phanjaroen (Medical echnologist), Namon Sawatwong (Medical echnic Assistant), Alisa Kanbumroung (Medical echnologist)
H I V- N AT ANNUAL REPORT 2 0 1 2 71 tHai rEd cross aids rEsEarcH cEntrE PErsonnEL
sociaL PsYcHoLogY and bEHaVior tEam From the let side: Rangsit Sanguansak (AR Secretariat Programme O cer), Panisa Kaisakulket (Administration Sta), Wannee Khaiwkhaopho (Project Coordinator), ippawan Sutthikiri (Project Manager), Kamolset Kanggarruer (Senior Proessional Level (K 3) Social Work), Taneth Kanteeranon (Research Assisant) Missing: Somsri antipaibulvut (Chie Group o Social Psychology and Behavior), Taedsak Jumnugsin (Project Coordinator), Sutep Onkumpung (Project Coordinator), Kittapol Tumdee (Project Coordinator) and Jutamart Rojwisatsap (Administration Sta)
sPEciaL task ForcE tEam From the let side: Jureeporn Jantarapakde (Research Dietician and Clinical rial Program Coordinator), Rosalin Kriengsinyot (Senior Social Worker), Somsong eeratakulpisarn (Chie o SF and Program Coordinator), Jiravut Keeratikongsakul (Peer supporter group leader MSM project), Waraporn Sirisakyot (Clinical rial Assistant), Kanyarat Tonglaem (Data Entry Sta), Kobkun Meepaeng (Clinical rial Nurse)
sPEciaL task ForcE tEam From the let side: Sumitr ongmuang (Clinical rial Assistant), Chayaporn asai (Financial Controller and eam Manager), Piranun Hongchookiat (Clinical rial Nurse), Supabhorn Pengnonyang (Research Dietician, Clinical rial Nurse and Program Coordinator), Natchaya Kongkaruek (eam Secretary Assistant), Sukanda Sutamkittiwut (Research Dietician), Supaporn Sompoo (Pharmacist Assistant), Pravit Mingkwanrungrueng (Clinical rial Assistant and Data Entry Sta)
72 H I V- N AT ANNUAL REPORT 2 0 1 2 SEARCH 014: Study o epidermal nerve fber density, subcutaneous at and mitochondrial para- meters in Tai HIV-positive patients on long-term stavudine treatment and in Tai HIV-negative patients. Tis study is to compare the density o epidermal nerve bers in the distal leg and the markers o mito- chondrial oxidation in at tissue and peripheral blood in people who are currently taking d4 and develop numbness with those who do not have numbness and those without HIV inection. About 100 subjects have been enrolled. Te study is unded by the US NIH (5 R01 NS063932-02 revised). Tis study will conclude sh E a reeh cll in 2013. wh Hw (sEarcH) SEARCH 007: HIV-1 specifc immune responses in Tai individuals with HIV dementia. SEARCH is a partnership that began in 2005 with Tis study completed enrolling 60 patients to assess the goal o accomplishing mutual objectives in HIV/ the HIV-1 specic CD4+ and CD8+ cell responses, AIDS research and training in the South East Asia and monocyte/macrophage activation and/or dysregu- region between 3 partners: the Tai Red Cross AIDS lation in individuals with and without HIV-associated Research Centre (RCARC) and HIV-NA in Bangkok, dementia prior to and ater HAAR. Subjects are still the Hawaii Center or AIDS o the John A. Burns School being ollowed at Phramongkutklao Hospital and o Medicine, University o Hawaii (UH) at Manoa in at SEARCH. Te study is unded by the US NIH (R01 Honolulu, and the Armed Forces Research Institute o NS053359-01A1) and will be completed in 2013. Medical Sciences (AFRIMS) in Bangkok. SEARCH has 3 co-directors: Proessor Praphan Phanuphak (RCARC), Proessor Cecilia Shikuma (UH), and COL. Jerome Kim SEARCH 011: Peripheral reservoir o HIV DNA in (AFRIMS). SEARCH is headed by Dr. Jintanat Anan- monocytes pivotal to cognition in HIV. woranich with Dr. Nittaya Phanuphak occupying the Tis study completed enrolment o 60 subjects at role o Deputy Chie. Phramongkutklao Hospital and at SEARCH. It will determine the long-term relationship between cognition and HIV DNA in circulating monocytes and dene the longitudinal relationships between HIV DNA in mono- ongoing cLinicaL studiEs cytes and cerebrospinal fuid biomarkers and MRS ndings. Te study is unded by US NIH (R01 SEARCH 002: Establishing normal values or AI075408-01). Te study will be completed in 2013. neuropsychological testing in Tai. Tis study completed enrollment o 483 HIV-negative SEARCH 010: Establish and characterize an acute HIV Tai aged 20-79 years old to establish normal values inection cohort in a Tai high risk population. or neuropsychological testing panels. Te public can Tis study has enrolled 77 patients with acute HIV request use o these data via the SEARCH website inection (HIV antibody negative, nucleic acid positive) (www.searchthailand.org). Subjects are enrolled at and plan to expand inclusion to 150 subjects to be Phramongkutklao Hospital and at SEARCH. ollowed or 5 years. Investigations o the reservoir size, viral sequences and immune responses in the SEARCH 003: Comparing the toxicity profle o a peripheral blood, sigmoid colon, genital secretions and d4-based regimen as lead-in or the frst 6 months central nervous system are ongoing and some data versus AZ-based and DF-based frst line regimens. have been published (Ananworanich J, et al. PLoS ONE Te study completed its 72-week ollow up in 150 2012; Valcour V, et al. J Inect Dis 2012). Te study patients rom the RCARC and Queen Savang Vadhana is unded by the US Military HIV Research Program Memorial Hospital last year. Te clinical outcomes (MHRP) and by the US NIH (R01MH095613)). (Phanuphak N, et al. Antiviral Terapy, in press) con- Subjects are oered 5 vs. 3-drug HAAR under a cluded that a 6-month d4 lead-in therapy was sae separate protocol with drugs made available by the and could be considered in patients with anemia or low Tai Government Pharmaceutical Organization, Gilead, baseline CD4. A second publication (Shikuma CM, et Merck and ViiV Healthcare. Tere is increasing interest al. HIV Medicine, May 11) demonstrated substantially in early-treated acute HIV inection in the context o higher density o epidermal nerve ber in the distal leg unctional cure and urther interventions involving o HIV-inected Tai adults compared published norma- therapeutic HIV vaccine and drugs targeting the HIV tive data rom the U.S, leading to a ollow-up study reservoir are being planned. In addition, this study has (SEARCH 014, see below) to investigate this urther. led to the development o the SEARCH 013 study to Analyses on stored samples to decipher the pathoge- enroll HIV-negative and chronic HIV-inected controls nesis o mitochondrial toxicity and neuropathy are still or comparison o immunologic and virologic para- ongoing. Te study is unded by the Tai Government meters with acute HIV-inected subjects. Pharmaceutical Organization and the US NIH (R01 AI074554-01A1 and R01 NS063932-01).
H I V- N AT ANNUAL REPORT 2 0 1 2 73 SEARCH 013: Characteristics o immune cells in gut training mucosa o HIV-negative and HIV-positive Tai. Tis study is enrolling HIV-negative and non-acutely SEARCH coordinates training upon request centred HIV-inected adults to perorm immunologic/virologic around themes including basic and advanced HIV investigations in the peripheral blood and sigmoid medicine and second line antiretroviral therapy or colon or comparison with subjects with acute HIV adults and children. SEARCH has coordinated training inection in the SEARCH 010 study. o date 10 HIV- programs or PEPFAR Vietnam, WHO India, UNICEF negative volunteers and 5 non-acutely but recently HIV China, Health [e] Foundation and amAR REA Asia. inected volunteers have been enrolled. Te study is In 2011, SEARCH provided our training courses on the unded by US MHRP and will conclude in 2014. topic o “Psychosocial raining to Enhance reatment Success or Children and Adolescents”, supported by SEARCH 015: A cohort observational study the GILEAD oundation and REA Asia while a ollow evaluating predictors, incidence and immunopatho- up session took place in May 2012. raining courses genesis o immune reconstitution syndrome (IRIS) in were provided in Bangkok, Petchburi and Southern HIV-1 inected patients with a CD4 count <100 cells/ Tailand with 40 Tai physicians, nurses, mental health µL who are initiating antiretroviral therapy. and social workers, attending each o three sessions. Tis study is to characterize IRIS and investigate the Te ourth session was an international training pathogenesis and the outcomes o IRIS. Te study has session on the same topic or 26 physicians, nurses, begun enrolment in 2012 at RCARC and Bamrasnara- mental health and social workers rom the REA Asia dura Inectious Diseases Institute. Te study is unded network in Southeast Asia. Te international session by the US NIH and the US MHRP. included lectures, a children’s art camp and eld trip activities. Improving the diagnosis and management o latent B in Tai children. SEARCH has been working towards building an Tis study has completed. It enrolled 158 children inrastructure or NeuroAIDS research in Southeast with a history o B contact to assess the sensitivity Asia by providing training and quality assurance in and specicity o the intereron-gamma release assays neuropsychological testing to nurses and neurologic and tuberculin skin test in screening or latent B in examination to physicians. SEARCH holds a regular HIV-positive and –negative children. Te study was a SEARCH Research Forum to encourage collaboration in collaboration between SEARCH, HIV-NA, Siriraj NeuroAIDS, acute HIV inection and HIV pathogenesis. Hospital, Queen Sirikit National Institute o Child In May 2012, SEARCH organized a special lecture Health and Columbia University. Te study was unded on NeuroAIDS. Te lecture topics included pathoge- by ibotec’s REACH Initiative Award. nesis, clinical maniestations and management o CNS involvement in acute HIV inection. SEARCH studies HIV vaccine studies in collaboration with AFRIMS have shown that DNA predicts cognitive impairment and the US Military HIV Research Program: and brain injury in antiretroviral-naïve Tais initiating SEARCH will be involved in mucosal compartments rst line therapy. Te speakers were Dr. Serena investigations or three ollow up studies rom the Spudich, an Associate Proessor at Yale School o RV144 phase III prime-boost ALVAC® and AIDSVAX® Medicine and Dr. Victor Valcour, an Associate Proessor B/E vaccines trial. In addition, SEARCH will be the at University o Caliornia at San Francisco. In October study site or one o these studies (RV328, SEARCH 2012, SEARCH hosted a mini symposium on the role 016), a study o AIDSVAX® B/E vs. placebo in 40 o secondary lymphatic tissue in HIV-associated volunteers at low risk or HIV inection to study immune deciency and infammation with lectures rom immune responses in blood and mucosa. Te study world renowned experts, Drs. im Schacker and Jerey is anticipated to start in early 2013. Chipman rom University o Minnesota and Dr. Daniel Douek rom the US NIAID Vaccine Research Center. MSM research program: SEARCH has a major role in some o the RCARC’s MSM research programs. Te study to identiying biomarkers (HPV subtype, p16, MCM proteins, E6 and E7 mRNA) to detect high- PEdiatric PsYcHosociaL suPPort grade anal intraepithelial neoplasia among Tai MSM actiVitiEs with and without HIV inection has been unded by the IeDEA grant through amAR and REA Asia. SEARCH, on behal o the Tai Red Cross AIDS Te www.adamslove.org is an edutainment interac- Research Center, is the recipient o a REA Asia tive website that aims to use social networking as an Award to conduct a project called ‘ Interventions to attractive HIV education and prevention tool. Over Promote Retention in Formal School System’. Te aim 228,000 visitors and more than 40 million hits were o the project is to give support to promote retention recorded since September 2011. SEARCH is also in ormal school system to children and adolescents working in collaboration with the World Bank to model who are at risk o or have dropped out o the ormal the impact, costs and returns on investment o com- school system and their care givers. prehensive prevention in the epidemic o HIV in MSM in Bangkok.
74 H I V- N AT ANNUAL REPORT 2 0 1 2 H I V- N AT ANNUAL REPORT 2 0 1 2 75 sEarcH PErsonnEL
From let to right: Michittra Boonchan (Laboratory echnician), Varaporn Pothipala (Business Manager), Somporn ipsuk (Research Nurse), Puttachard Sangtawan (Research Nurse), Siriporn Nonenoy (MSM Manager), Dr.James Fletcher (Physician)
From let to right: Dr.Jintanat Ananworanich (Chie o SEARCH), Nitiya Chomchey (Clinical rials Manager), Chayanin Sutthichom (Data Entry), Peeriya Mangyu (Research Nurse), Siriporn Sangthong (Administrative Assistant), Sasiwan Srikhaw (Administrative Assistant)
Missing Persons: Dr.Nittaya Phanuphak (Deputy Chie o SEARCH), Dr.Tep Chalermchai (Physician), Dr.Eugene Kroon (Physician), Ratchapong Kanaprach (I/Data Manager), Sudrak Lakonphon (Children’s program Manager), Patcharawee Rungrojrat (Monitor), Somprartthana Ratanamanee (Research Nurse), Duanghathai Suttichom (Research Nurse), Sangla Najai (Social Worker Assistant), Chutima Ketbanrung (Social Worker Assistant)
76 H I V- N AT ANNUAL REPORT 2 0 1 2 communitY outrEacH Programs SUMMARY REPOR OF HE ACIVIIES FOR HIV-INFECED CHILDREN AND PARENS A HE HAI RED CROSS AIDS RESEARCH CENRE Period: October 2011 to September 2012
The Children and Youth Program is a community outreach program under the auspices of the Thai Red Cross AIDS Research Centre (TRC-ARC) and conducted by SEARCH and HIV-NAT, which are subunits within the TRC-ARC in Bangkok, Thailand. The program is supported by three charities: The Born to Live Charity, The ART AIDS Fund and Living and Loving. Due to worldwide economic problems, funding from all three charities has dramatically declined since January 2010. Although financial support from international sources has been reduced, sponsors have continued to recognise the importance of psychosocial care and currently reassess their funding on an annual basis. The international sponsors have indicated that they would like us to seek increased support from within the country. Staff from HIV-NAT, SEARCH and the Thai Red Cross AIDS Research Centre are therefore engaged in fundraising activities, such as selling T shirts and musical tickets, via The Wish Your Love campaign, in order to allow the Children and Youth Program to continue supporting children and their families. The Program’s core mission is to provide psychosocial and financial support so that children and their families can live and cope with HI V. The Program carries out assessments of children’s psychosocial problems and provides psychosocial support both at the HIV-NAT clinic and during home visits. It provides psychosocial training for health care providers involved in the children care network.
1. Te 3 t Pyhl spp chle alee Lv wh HiV F Helh ce Pve oe 17 –21, 2011 b Pheh sppe y gle trEat a.
A 5-day training session was conducted or 22 persons rom 18 organizations:
• Country : Cambodia 3 persons, India 2 persons, Indonesia 2 persons, Laos 2 persons, Malaysia 4 persons, Myanmar 1 person, Tailand 4 persons, Vietnam 4 persons • Organizations : 15 Hospitals, 2 Non-prot Organization, 1 Private International Association, 3 Social Support Foundations, 1 Research Centre
Te Objectives are to understand and learn about psychosocial support interventions which promote treatment success and improve quality o lie or children and adolescents living with HIV and to establish pediatric HIV psychosocial support networks within the region.
H I V- N AT ANNUAL REPORT 2 0 1 2 77 Te main content o the training session was concerned with increasing knowledge and basic skills in childhood and adolescent psychosocial development, mental health assessments, HIV disclosure counseling, promotion o ARV adherence and promotion o sex education. As part o the training or health care workers rom South East Asia, study visits and participatory activities with HIV-inected individuals in the Youth Camp were added in order to reinorce learning points derived rom work in Tailand.
At the camp, participants were invited to observe psychosocial-related activities to promote ARV adherence and sex education such as art ses- sions to express themes and issues in youths’ lives and identities, youth group learning to review and promote understanding regarding HIV and sex education.
2. Sex edcation in Yoth on 17-18 Feb and 16-17 March 2012
10-15 teenagers watched a movie, cooked ood, had an inormal discussion about liestyle and spent the night together at the SEARCH o ce (ower 2 o Te Tai Red Cross AIDS Research Centre). Te discussion centred around sex education and that the term describes a lielong process o acquiring inormation and orming attitudes, belies and values. It encompasses sexual development, sexual and reproductive health, interpersonal relationships, aection, intimacy, body image and gender roles. Sex education should assist young people in developing a positive view o sexuality, provide them with inormation and skills or taking care o their sexual health and help them make sound decisions now and in the uture.
3. Small camp at Baan Khn Yai (Grandmother’s Home Camp) on 20-21 March 2012
Tere were 8 children at this camp, all o whom had just discovered their HIV status. Tey attended activities learning about the treatment o AIDS and how HIV can be suppressed by combination ARV therapy. Te children learned to distinguish between a person who has HIV and a person who has AIDS. Tey also learned about HIV transmission, how it can be transmitted through unprotected sex and how it can be transmitted rom mother to child. Tey ound out how to take care o themselves and how to be healthy with HIV. Tree youth volunteers were also present and shared their experiences o how they take care o themselves.
78 H I V- N AT ANNUAL REPORT 2 0 1 2 4. One day activities for children in Kao Din Zoo on 11 April 2012
Children rom 4-7 years old had an ad- venture and practiced painting at the zoo while their caretakers had their own activities.
We prepared the caretakers or the process o pre-disclosure. Te core message at the event was that AIDS can be treated and HIV can be sup- pressed by ARV; this was reinorced using the “My World” book. Te caretakers also learnt how to promote child development and build group support.
On 20 April 2012
Children o 8-11 years old and their caretakers who had never beore attended a camp visited Kao Din Zoo. Tey received advice and training in the physical and psychological changes that accompany puberty and learnt about how to look ater their health and hygiene as well as broaching the topic o sexual development and sexuality. Tey also practiced relationship skills and sel-esteem, which play a central role throughout our lives.
5. Te 4th raining in Psychosocial Spport for Children and Adolescents Living with HIV for Health Care Providers spported by Gilead on May 1-4, 2012 in Nakhon Sri Tammarat Province, Tailand.
Te children working group ound that there are still very ew organizations ocused on the care o children and adolescents living with HIV in Southern Tailand. Moreover, existing sta and volunteers lack experience in psychosocial techniques. o improve this situation, it is proposed that sta should be supported with urther training that emphasizes real-lie experience in conducting psychosocial activities or children and adolescents. Consequently, SEARCH organized this workshop in the orm o a youth camp at which trainees could take part in working groups, practical sessions and communal leaning. Tis workshop attracted colla- boration and cooperation rom the Tai Network o People Living with HIV/AIDS Southern Region (NP+ Southern) and the AIDS Access Foundation in designing activities and coordinating agencies in the local area.
H I V- N AT ANNUAL REPORT 2 0 1 2 79 A total o 47 participants participated in this workshop: 19 rom 6 organizations, 7 rom various hospitals and 21 adolescents living with HIV. Tere were 7 people in each team o trainees, namely: 2 people rom the We Understand Group, 2 people rom the Youth Volunteer-Child and Youth Project, 2 people rom the SEARCH Research Unit and 1 person rom the Knowledge Network Institute o Tailand.
Participating in the camp training process helps trainees to gain new perspectives and counseling techniques that they are able to take home and apply in their local communities. Specifc knowledge gained included an understanding o methods o imparting and developing knowledge about HIV to adolescents that help them to understand the issues more easily as well as actors to consider in the development o group activities. In addition to this, trainees were able to directly observe the changes in adolescents who participated in the activities; or example, the adolescents bonded and became more willing to share their stories and experiences with one another. Tey also developed an increased understanding o HIV and how they might manage their disease while living a ull lie and engaging in their communities.
All o the adolescents reported satisaction with and gratitude that they could participate in the activities. Tey elt that they had gained know- ledge about not only HIV, but also other aspects o sex education. Tey reported that they had had the chance to share their knowledge with the workshop trainees. Te adolescents elt this was valuable, and were proud o their participation. Tey also said that they gained moral support rom and made new riends with other adolescents in the camp.
6. Follow-p Workshop on Psychosocial Spport for Children and Adolescents Living with HIV, at the Jasmine Exective Sites Lxry Hotel, Bangkok, 16 – 18 May 2012 spported by REA Asia.
Te objectives o this session were to enhance the participants’ knowledge and skills in addressing psychosocial issues involving children and adolescents living with HIV as well as to guide participants in developing psychosocial support plans. Te participants consisted o 8 persons rom 8 separate organizations who attended the workshop on psychosocial support or children and adolescents living with HIV on 17- 21 October 2011, in Bangkok and Phetchaburi, Tailand. Te content o the workshop included a demonstration o group counseling with caretakers on the disclosure o positive HIV status to HIV-inected children and adolescents (children who already knew their HIV status volunteered to take part in these sessions and also helped to provide eedback or trainees) and subsequent practical sessions allowing trainees to develop their own positive HIV status disclosure skills via role play and practice counseling. Te participant also had simulated role play and counseling practice sessions with as well as simulated sessions to promote ARV adherence with caretakers o children and adolescents. Te workshop also involved group activities promoting sex education in HIV-inected children and adolescents and discussion o the role o caretakers in promoting sex education or HIV-inected children and adolescents. REA Asia also provided seed money to help trainees develop and implement similar activities in their home settings.
80 H I V- N AT ANNUAL REPORT 2 0 1 2 7. One day activities on 7 Jly 2012 spport by Standard Chartered Bank.
Te children had an opportunity to learn about portraiture and express their eelings by creating their own pictures. Ater that, they visited the Bangkok Art and Culture Centre. Tere, the children were able to learn about and try to understand dierent orms o art as well as become amiliar with a number o artworks.
8. Interventions to Promote Retention in the Formal School System spported by a social award from REA Asia.
Te children and youths enrolled in our program are an average o 12 years old. O the 87% o children in the ormal education system many are not encouraged by their caregivers to pursue higher education. O the 13% who are not in the ormal education system, all did start school but dropped out o school, mostly around grades 3-5 due largely to poor health, caregivers’ poor attitudes towards HIV/importance o education, HIV stigma and fnancial diculties. Tere is a second peak at grade 9, where primarily poorer students leave to fnd work rather than continue their studies. We have identifed two groups o children and youths who are in need o specifc interventions to promote school retention:
1) Children who are currently not in the ormal school system. 2) Children who are in the ormal school system but are at risk or dropping out or not pursuing higher education
On 27 November 2011 On 10 Jne 2012
en Grade 9 children who are in the ormal school Five children and system had guidance on educational options by an youths who are not expert educational counselor. Tey took an aptitude in the ormal school test and underwent individual counseling and group system together education.Tree older youths also shared their with 6 caregivers had experiences o higher levels o education. Te 7 group discussions. caregivers received guidance with the child on Te objective was educational options via indivi- dualized counseling to promote opportu- involving with the expert educational counselor. nities or academic study and other skill development as well as to empower On 11 March 2012 the children to reengage in the school system. Te content o the discussion included sharing inormation about the Tirteen Grade 10-12 children took an aptitude possibilities or and the importance o education and test and underwent individual counseling and group adjusting attitudes towards children and youths living education with an expert educational counselor. with HIV’s academic potential. Te children also had 3 o their caregivers were given guidance on higher sessions aimed at adjusting attitudes towards HIV/AIDS educational options by an expert educational and building understanding about how to deal with HIV counselor. stigma. In addition, peers who had reentered non-ormal education and continuedto study to university level also attended to share their experiences o education.
H I V- N AT ANNUAL REPORT 2 0 1 2 81 On 14 Jly 2012
Six children and 9 caregivers o children who are at risk o dropping out o school had group discussions to promote the importance o education and intervene with the children. Tey received inormation about academic opportunities and discussed the importance o education and adjusting attitudes surrounding the educational potential o children and youths living with HIV.
9. Wai een Camp (Yoth Camp) on 2-3 Agst 2012 arranged by Assoc. Pro. Chitsanu Pancharoen and his team and supported by the Department o Pediatrics at King Chulalongkorn Memorial Hospital.
A total o 25 adolescents and medicals sta attended a one-and-a-hal day camp at Nakorn Nayok. Assoc. Pro. Chitsanu, an expert on communication in clinical practice, created the camp so that the teenagers and sta would have a dedicated time to listen to and learn rom one another, in an atmosphere that is non-judgmental, understanding and warm. Tey shared their eelings and developed a closer relationship. Te stas were able to demonstrate their respect or the teenagers, while the youths developed a confdence that the sta were unconditionally ond o them and had their best interests at heart.
10. Te book entitled, “My World,” is pblished and spported by REA Asia
A picture book entitled “My World” was made to support caregivers in reading or telling stories to children. Tis book will help children learn about HIV and how to live with the inection. Counselors and related healthcare proessionals working with children living with HIV in Malaysia and Indonesia elt that the “My World” educational booklet would be hugely benefcial or children there and asked or it to be translated into their respective languages. REA Asia kindly arranged and covered the cost o the translation and printing o “My World” into Bahasa Malaysia and Bahasa Indonesia.
“My World” in Bahasa Indonesia.
“My World” in Bahasa Malaysia
82 H I V- N AT ANNUAL REPORT 2 0 1 2 ACKNOWLEDGEMENS
We would like to express our sincere gratitude and heartelt appreciation to the ollowing Institutional Review Boards (IRBs), without whom these studies would not be possible:
HAILAND 1. Institutional Review Board o the Faculty o Medicine, Chulalongkorn University 2. Te Ethical Review Committee or Research in Human Subjects, Ministry o Public Health (MOPH) 3. Te Institute or the Development o Human Research Protections (IHRP) 4. Internal Ethics committee, Chiangrai Prachanukroh Hopital 5. Te Siriraj Institutional Review Board (SIRB) 6. Institutional Review Board o Bamrasnaraduru Inectious Diseases Institute 7. Committee on Human Rights Related to Researches Involving Human Subjects, Faculty o Medicine, Ramathibodi Hospital 8. Research and Ethic Committee Chonburi Regional Hospital 9. Research and Ethic Committee Queen Savang Vadhana Memorial Hospital 10. Research and Ethic Committee Prapokklao Hospital 11. Te Khon Kaen University Ethics Committee or Human Research 12. Ethics Committee Researches Involving Human Subjects, Te Bangkok Metropolitan Administration 13. Te Ethics Committee Rajavithi Hospital 14. Te Ethics Committee Suratthanee Hospital 15. Te Research Committee, Faculty o Medicine, Chiang Mai University 16. Te Ethics Committee Buddhachinaraj Hospital 17. Te Ethics Committee Nakornping Hospital 18. Te Ethics Committee Phrachomklao Hospital 19. Te Ethics Committee Surin Hospital 20. Te Research Ethic Review Committee o Queen Sirikit National Institute o Child Health (Children’s Hospital) 21. Te Ethics Committee Sappasitthiprasong Hospital 22. Te Ethics Committee Udonthani Hospital 23. Te Committee or Research in Human Subject, Department o Disease Control, Ministry o Public Health 24. Te Khon Kaen Hospital Committee or Human Research
CAMBODIA 1. Ministry o Health, National Ethics Committee or Health Research
INDONESIA 1. Te Kerti Praja Foundation Institutional Review Board, Denpasar, Bali, Indonesia 2. Te Ethical Committee o the Faculty o Medicine, University o Indonesia, Jakarta, Indonesia
VIENAM Te Ethical Review Board or Biomedical Research, Hanoi School o Public Health
Please note that this list is not exclusive nor exhaustive. Since new research studies are developed and existing studies change, it is possible that some IRBs may not be listed.
H I V- N AT ANNUAL REPORT 2 0 1 2 83 SPONSORS
INERNAIONAL SuPPOR DOMESIC SuPPOR
Pharmacetical Partners Governmental Agencies Abbott Commission o Higher Education, Ministry o Bristol-Myers Squibb Education (CHE) Chiron Corporation Governmental Pharmaceutical Organization (GPO) Gilead Sciences Ministry o Public Health (MOPH) Matrix National Health Security Oce (NHSO) Merck & Co., Inc Oce o the National Research Council o ROCHE Pharmaceutical Tailand (NRC) ibotec Pharmaceuticals Social Security Oce (SSO) Viiv Tai Research Fund (RF) Glaxo Smith Kline Department o Disease Control (DDC) Boehringer Ingelheim National Research University (NRU)
Academic Organizations Academic Organizations AMC Amsterdam Institute or Global Health Ratchadaphiseksomphot Fund, Faculty o Medicine, Development (AIGHD) Diseases, University o Chulalongkorn University Amsterdam Foundation or AIDS Research, United States Research Organizations (amAR) HIV-NA Te Kirby Institute or Inection and Immunity Tai Red Cross AIDS Research Centre in Society was ormerly known as the National Centre in HIV Epidemiology and Clinical Research, Fnding Agency University o New South Wales (UNSW), Te Aligning Care and Prevention o (Sydney, Australia) HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project Research Organizations (Global und Tailand) Pediatric European Network or reatment o AIDS Swiss HIV Cohort Study
Fnding Agencies Bill & Melinda Gates Foundation National Institute o Allergy & Inectious Diseases (NIAID), Division o AIDS (DAIDS), National Institute o Health (NIH)
Charities Art AIDS Fund Born to Live Charity Living & Loving Charity
Note: Bristol-Myers Squibb provides lie-time AV or some patients. Gilead-Sciences provides ruvada or some patients. ROCHE Pharmaceutical provides lie-time SQV or all patients rom HIV-NA 001.4, SACCAO, HIV-NA 019, -20, GEMINI, HIV-NA 017 and HIV-NA 096. Te Aligning Care and Prevention o HIV/AIDS with Government Decentralization to Achieve Coverage and Impact: Project (Global und Tailand) supports ARV and some CD4 and viral load testing.
Please note that this list is not exclusive nor exhaustive. Since new research studies are developed and existing studies change, it is possible that some sponsors may not be listed.
84 H I V- N AT ANNUAL REPORT 2 0 1 2 Cover Design: Pornwinit Sattayamongkol
H I V- N AT ANNUAL REPORT 2 0 1 2 85