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1 Clinical Trial Details (PDF Generation Date :- Tue, 17 Jul :15:16 GMT) CTRI Number Last Modified On 01/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/10/ [Registered on: 11/10/2011] - Terminated Trial Registered Interventional Drug Other A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NCT A ClinicalTrials.gov Protocol Number Details of Principal Investigator Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, , C/O Wyeth Limited, 6th Floor, Platina, Plot C-59, G Block, Bandra-Kurla Complex, Bandra (E), Details Contact Person (Scientific Query) Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West,,, , C/O Wyeth Limited, 6th Floor, Platina, Plot C-59, G Block, Bandra-Kurla Complex, Bandra (E), Details Contact Person (Public Query) Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study,, , C/O Wyeth Limited, 6th Floor, Platina, Plot C-59, G Block, Bandra-Kurla Complex, Bandra (E), Source of Monetary or Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Type of Sponsor NIL List of Countries Argentina Australia Brazil Canada Italy Mexico Other Poland Portugal South Africa Switzerland Taiwan Ukraine United Kingdom United States of America of Principal Investigator Dr. Janak Keshavlal Maniar, MD Dr. Ravindran Gherad Dhanapal, M.D., DNBE Dr. Sanjay Pujari Primary Sponsor Details Pfizer Limited Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, , Pharmaceutical industry-global Nil of Site Site Phone/Fax/ Department of HIV Medicine, Jaslok & Research Centre Department of Medicine, St. John's Medical College IID Institute of Infectious Diseases Kumar Business Court 15, Dr. Deshmukh Marg, Sarjapur Road,, Bangalore KARNATAKA D Wing 1st Floor, Near Swargate Bus Stand,Mukund Nagar Pune / jkmaniar@vsnl.com gd_ravindran@yahoo.c o.in sanjaypujari@gmail.co m page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr. Manjunath Dinaker Mediciti, Secretariat Road, Hyderabad ANDHRA PRADESH Dr. Amar Pazare Dr. Nagalingeswaran Kumarasamy, MBBS., PhD Seth G. S. Medical College and KEM Acharya Dhonde Marg, YR Gaitonde Centre for Taramani,, AIDS Research and Chennai Education (YRG CARE) TAMIL NADU Voluntary Health Services Extn: jitika@sify.com arpazare@rediffmail.co m 044? kumarasamy@yrgcare. org of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee, Jaslok & Research Centre Ethics Committee for Research on Human Subjects, Seth G.S. Medical College & KEM Independent Ethics Committee, Chest Research Foundation Institutional Ethics Board, St. Johns Medical College Medical Ethics Committee, Department of Medicine, Mediciti YRGCARE Institutional Board, Y.R.Gaitonde Medical Educational & Research Foundation Status Date Approved/Obtained 28/07/2010 Health Type Patients Condition HIV-1 Type Details Intervention Intervention the lersivirine arms Who discontinue for virologic failure or any other reason the lersivirine arms Who are on a dropped lersivirine the week 24 futility analysis Yes Yes May go into the A study. The study does not involve lersivirine. These patients will be observed for one year (six monthly visits) May go into A They will have their investigator-prescribed treatment regimen reimbursed by Pfizer while enrolled in study A until lersivirine is page 3 / 5

4 Inclusion Criteria Comparator Agent Age From Age To Gender Details the comparator arm Who discontinue for virologic failure or any other reason Year(s) Year(s) Both Inclusion Criteria marketed or discontinued. May go into the A study. The study does not involve lersivirine. These patients will be observed for one year (six monthly visits) 1. Previous participation in a qualifying study. 2. Male or female at least 18 years of age available for a follow-up period of at least 96 weeks. te: there is no upper age limit for inclusion criteria for this trial Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details t Applicable t Applicable t Applicable Exclusion Criteria Concurrent treatment in another clinical trial. Unwilling or unable to be followed for Primary Outcome Outcome Timepoints Safety assessed by adverse events Secondary Outcome Outcome Timepoints Target Sample Size Percentage of subjects with HIV 1 RNA level <50 copies/ml CD4+ lymphocyte count (absolute and percentage) Total Sample Size=330 Sample Size from =10 Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 01/07/2009 Years= Months= Days= Completed Other (Terminated) ne Study Design is Open-label Single arm trial. Stydy Type: n-randomized, roll over observational study Phase of the trial is Phase 2B/3. A total of 10 subjects from will be included in the study. In the study has not been initiated and will be initiated only after the DCGI approval and CTRI registration. The anticipated date of enrollment in is 15 v Intervention and Comparator/Control agent: Investigational page 4 / 5

5 Powered by TCPDF ( PDF of Trial drug- Lersivirine will not be administered in study A This rollover study will only include patients who discontinue early from the parent study (A with reference as CTRI/2010/091/ ) due to virologic failure or for any other reason. All such patients will be followed for one year to determine how they are responding to their next regimen (Standard of Care) and to capture information we have been asked to obtain by regulatory agencies. Patients will be contacted by phone at 6 month intervals. At the time of each telephone call, if it is determined that the patient has not had a viral load measurement taken within a specified period then s/he will be asked to come in to the clinic to have this testing done. te: There are two lersivirine arms (750 mg once daily and 1000 mg once daily) in A (CTRI reference no. as CTRI/2010/091/001049). At the 24 week futility analysis it is possible that one of these arms may be dropped. For patients entering study A from a discontinued lersivirine arm, the investigator-prescribed treatment regimen will be reimbursed by Pfizer until lersivirine is marketed or discontinued and for as long as the patient remains enrolled in study A This duration of follow-up will allow patients on a discontinued arm to retain the same duration of treatment originally offered when they agreed to participate in the parent studies. However, the study duration has not changed for patients discontinuing from the parent studies due to reasons other than meeting the Week 24 futility criteria, i.e., these patients will be followed for a duration of one year. Globally the recruitment is Completed: Closed to recruitment of participants and follow up ongoing) (This study was not initiated in for recruitment as Global recruitment completed prior to Regulatory Approval. Globally, recruitment has completed and follow up is ongoing for recruited subjects.) page 5 / 5