Clinical Trial Details (PDF Generation Date :- Tue, 17 Jul 2018 00:15:15 GMT) CTRI Number CTRI/2010/091/001049 [Registered on: 28/06/2010] - 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 Interventional Drug Randomized, Parallel Group, Active Controlled Trial A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced Infected Subjects With Evidence Of NNRTI Resistant A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced Infected Subjects With Evidence Of NNRTI Resistant 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) A5271022 NCT00823979 Protocol Number ClinicalTrials.gov Details of Principal Investigator,, 400 102, C/O Wyeth Limited, 6th Bandra (E), 400098. Details Contact Person (Scientific Query),, 400 102, C/O Wyeth Limited, 6th Bandra (E), 400098. Details Contact Person (Public Query) page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study,, 400 102, C/O Wyeth Limited, 6th Bandra (E), 400098. Source of Monetary or Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, 400 102 Type of Sponsor NIL List of Countries Brazil Germany Italy Malaysia Other Poland Portugal South Africa Spain 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, 400 102, 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 15, Dr. Deshmukh Marg,-400 026 Sarjapur Road,-560034 Bangalore KARNATAKA Kumar Business Court, D Wing 1st Floor,Near Swargate Bus Stand, 0222368 0288 02223523504 jkmaniar@vsnl.com 0802206 5352/09880081770 080-25530070/ 25633727 gd_ravindran@yahoo.c o.in 020-24274950 020-242648025 sanjaypujari@gmail.co page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Mukund Nagar-411 037 Pune Dr. Manjunath Dinaker Mediciti Secretariat Road,-560 063 Hyderabad ANDHRA PRADESH Dr. Amar Pazare Dr. Nagalingeswaran Kumarasamy, MBBS., PhD Seth G. S. Medical College and KEM Acharya Dhonde Marg,Parel -400 012 YR Gaitonde Centre for Taramani,-600113 AIDS Research and Chennai Education (YRG CARE) TAMIL NADU Voluntary Health Services m 040-23231111 Extn:-67 2/+91-9848052862 040-23231631 jitika@sify.com 022-24126766/+91-982 0572212/+91-97677308 21 022-24126766 arpazare@rediffmail.co m 04422542929 04422542939 kumarasamy@yrgcare. org of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee for Research on Human Subjects, Seth G.S. Medical College & KEM Submittted/Under Review Ethics Committee, Jaslok & Research Centre, 15, Dr. G. Deshmukh Marg, -400026 Maharashtra Approved 18/01/2011 Independent Ethics Committee, Chest Research Foundation, Institutional Ethics Review Board, St. Johns Medical College Mediciti Ethics Committee, Institutional Ethical Review Board, Department of Medicine, Mediciti YRGCARE Institutional Review Board, Y.R.Gaitonde Medical Educational & Research Foundation, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai 600 113 TamilNadu Status Approved 09/02/2011 Yes Approved 20/07/2010 Approved 04/06/2010 Yes Submittted/Under Review Date Approved/Obtained 26/05/2010 Health Type Condition page 3 / 5
Intervention / Comparator Agent Inclusion Criteria Patients Type Details Intervention UK- 453,061 Dose One Drug: UK-453,061 Dose 1: UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir Intervention UK- 453,061 Dose Two Drug: UK-453,061 Dose 2: UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir. Comparator Agent Active Comparator Drug: Etravirine: Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir Age From Age To Gender Details 18.00 Year(s) 65.00 Year(s) Both Inclusion Criteria 1.Male or female at least 18 years of age available for a follow-up period of at least 96 weeks. 2.HIV 1 RNA viral load of greater then 500 copies/ml. 3.Negative urine pregnancy test. Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Centralized t Applicable Exclusion Criteria 1. Suspected or documented active, untreated related opportunistic infection or other condition requiring acute therapy at the time of randomization. 2. Subjects with acute Hepatitis B and/or C within 30 days of randomization. 3. Previous use of Darunavir or etravirine Primary Outcome Outcome Timepoints Percentage of subjects with RNA <50 copies/ml at 24 weeks. 24 weeks Secondary Outcome Outcome Timepoints The percentage of subjects with RNA <50 copies/ml and <400 copies/ml at various time points The change from baseline in log10 transformed HIV 1 RNA levels Assessment of Genotypic and phenotypic resistance at various time points The time-averaged difference (TAD) in log10 transformed HIV 1 RNA levels at various time points. The percentage of subjects with virologic response at different time points. Change from baseline in CD4+ cell counts (absolute and percentage). Safety and tolerability as measured by spontaneous adverse event reports, serious TBD 48-96 weeks 96 weeks page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Target Sample Size adverse events and safety laboratory tests. Pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analyses (to be reported separately). Total Sample Size=90 Sample Size from =0 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 01/03/2009 Years=3 Months=0 Days=0 Completed t Applicable ne 48 weeks This study was not initiated in for recruitment as Global recruitment completed prior to Regulatory Approval, Study is ongoing globally. page 5 / 5