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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 03:01:46 GMT) CTRI Number CTRI/2009/091/000298 [Registered on: 16/07/2009] - Last Modified On 26/09/2014 Post Graduate Thesis No Type of Trial Interventional Type of Study Vaccine Other (Specify) [Pilot study to study the safety and immunogenicity of Merck Quadrivalent HPV vaccine] Study Design Single Arm Trial Public Title of Study A clinical trial to study prevention of HPV in HIV-Positive women in India Scientific Title of A Single-Arm, Open-Label, Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Study Human Papillomavirus Vaccine among HIV-Positive Women in India: A Trial of AIDS Malignancy Clinical Trials Consortium Acronym: AMC Protocol # 054 Secondary IDs if Any Secondary ID Identifier AMC-054 Version 9.0; May 4 2012 Protocol Number NCT00667563 ClinicalTrials.gov Details of Principal Details of Principal Investigator Investigator or overall Name Dr N Kumarasamy Trial Coordinator (multi-center study) Designation Principal Investigator Affiliation YR Gaitonde Medical Educational & Research Foundation Address YR Gaitonde Medical Educational & Research Foundation, Voluntary Health Services, Rajiv Gandhi Salai, Taramani Chennai TAMIL NADU 600113 India Phone 04439106789 Fax 04422542949 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr N Kumarasamy Query) Designation Principal Investigator Affiliation YR Gaitonde Medical Educational & Research Foundation Address YR Gaitonde Medical Educational & Research Foundation, Voluntary Health Services, Rajiv Gandhi Salai, Taramani Chennai TAMIL NADU 600113 India Phone 04439106789 Fax 04422542949 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Sumeela Nair Designation Lead Data Manager Affiliation The EMMES Corporation Address EMMES Services Pvt. Ltd., Unit#3, The Mayfair, 316, 100 Feet Road, Indiranagar Bangalore page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in KARNATAKA 560008 India Phone 08041262300 Fax 08041480550 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > The National Cancer Institute (NCI) BG 9609 MSC 9760 9609 Medical Center Drive Bethesda, MD 20892-9760 Primary Sponsor Primary Sponsor Details Name AIDS Malignancy Clinical Trials Consortium Address AIDS-Associated Malignancies Clinical Trials Consortium, 9911 West Pico Boulevard Suite 980, Los Angeles, CA 90035 Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor Pharmaleaf India Pvt Ltd Represents The 2nd Floor, Daarul Awkaf, 6, Cunningham Road, EMMES Corporation for regulatory submission in Bangalore -560052 India Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr N Kumarasamy YR Gaitonde Medical Voluntary Health 04439106789 Educational & Services, Rajiv Gandhi 04422542949 Research Foundation Salai, Taramani 600113 kumarasamy@yrgcare. Chennai org TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? YRG Care Institutional Approved 05/04/2008 Yes Review Board Regulatory Clearance Status Date Status from DCGI Approved/Obtained 05/05/2009 Health Condition / Health Type Condition Problems Studied Patients 150 Female patients aged 18 years or older who have HIV-1 infection,as documented by any licensed ELISA test kit and confirmed by Western blot. Intervention / Type Name Details Comparator Agent Intervention Gardasil 3 doses at Day0, Week 8 and Week 24 Comparator Agent NIL NIL Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Female Details Women age 18 or older.<br/> <br/> Doucmented HIV-1 infection.<br/> <br/> If having a nadir CD4 level less than or equal to 350, must be on HAART for at least 6 months prior to entry.<br/> <br/> If having a nadir CD4 level greater than 350, must not be on page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in HAART at the time of study entry.<br/> <br/> <br/> Karnofsky performance score greater than or equal to 70 within 45 days prior to entry.<br/> <br/> Must not be pregnant at the time of enrollment and must be willing and able to practice contraception to avoid pregnancy for the one year duration of the study.<br/> <br/> Must not be breastfeeding a baby during the study.<br/> Exclusion Criteria Exclusion Criteria Details Current or history of high-grade CIN or cervical cancer. Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry. NOTE: Routine standard of care, including hepatitis B, influenza, and tetanus vaccines are not excluded. Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements. Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry. Inability to provide informed consent. Allergy to yeast or any of the components of Gardasil. Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To Determine the proportion of participants who Baseline through study discontinuation. respond serologically to the vaccine and the kinetics of the serologic response. Secondary Outcome Outcome Timepoints To determine the presence and level of CIN and Baseline, 9 months and one year after the spectrum of cervical HPV types in vaccination. participants. Target Sample Size Total Sample Size=150 Sample Size from India=150 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 1 Date of First 21/11/2009 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Publication Details CROI Abstract: AMC 054: Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Indian HIV-infected Women Conclusions: The quadrivalent HPV vaccine was safe and immunogenic in Indian HIV-infected women, regardless of CD4 level and HIV viral load. A high proportion of Indian HIV-infected women were “naïve” to vaccine HPV types and should be considered for HPV vaccination to reduce their risk of cervical cancer even though their mean age exceeded 26 years, the upper limit for catch-up vaccination in many countries. Brief Summary This primary goal of this study is to look at the side effects of Gardasil, an HPV vaccine, in HIV-infected women with no history of cancer of the cervix or changes in the cervix that could lead to cancer. The vaccine does not contain any infectious HPV and cannot lead to HPV infection. Another purpose of this study is to determine how often HIV-positive women acquire HPV infection of the cervix during the study. During the study the doctors will collect samples of cells from the cervix to test for HPV, collect samples of blood to test for antibodies, and perform examinations to look for signs of adverse events of the vaccine. The duration of the study is 52 weeks; a total of 150 participants will be enrolled based on their CD4+ levels. All participants will be vaccinated with Gardasil by intramuscular injection at Day 0, Weeks 8 and 24. Note: Change in protocol inclusion criteria with respect to nadir CD4+ levels. This change has been implemented based on the DCGI approval received on 28Apr2010 for amended version of the protocol. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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