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1 Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar :23:33 GMT) CTRI Number Last Modified On 03/02/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/06/ [Registered on: 06/06/2012] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group Trial Study of effectiveness of Stavudine 20mg taken two times daily in patients suffering from HIV-1 infection A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily)Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Efavirenz in Antiretroviral-Naive Patients Infected With HIV-1. 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) WRHI 001 (Version 2 dated 25 Oct 2012) Protocol Number Details of Principal Investigator Dr Nagalingeswaran Kumarasamy Principal Investigator Phone Fax YR Gaitonde Medical Educational & Research Foundation YR Gaitonde Medical Educational & Research Foundation, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai,. Chennai TAMIL NADU kumarasamy@yrgcare.org Details Contact Person (Scientific Query) Arun Sundriyal Phone Fax Associate Director, Clinical Management PPD Pharmaceutical Development Pvt. Ltd. PPD Pharmaceutical Development Pvt Ltd., Vatika City Point, 11th floor Sector 25, Mehrauli Gurgaon Road, Gurgaon HARYANA Arun.Sundriyal@ppdi.com Details Contact Person (Public Query) Arun Sundriyal Associate Director - Clinical Management PPD Pharmaceutical Development Pvt Ltd. PPD Pharmaceutical Development Pvt Ltd., Vatika City Point, 11th floor Sector 25, Mehrauli Gurgaon Road, Gurgaon HARYANA page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone Fax Arun.Sundriyal@ppdi.com Source of Monetary or Material Support > Wits Reproductive Health and HIV Institute (WRHI), University of the Witwatersrand, Hillbrow Health Precinct, Hugh Solomon Building, Corner Esselen Street, and Klein Street Hillbrow, 2001, South Africa Type of Sponsor Primary Sponsor Details Wits Reproductive Health and HIV Institute WRHI University of the Witwatersrand, Hillbrow Health Precinct, Hugh Solomon Building, Corner Esselen Street, and Klein Street Hillbrow, 2001, South Africa Research institution and hospital PPD Pharmaceutical Development Pvt Ltd List of Countries South Africa Uganda of Principal Investigator Dr Nagalingeswaran Kumarasamy 01-Dynasty B-Wing(Kanakia Spaces) Andheri-Kurla Road, Andheri East, Mumbai, MAHARASHTRA , of Site Site Phone/Fax/ YR Gaitonde Medical Educational & Research Foundation I Floor Room # 3 Clinical Trials Unit, YRGCARE Medical Centre VHS Chennai CRS, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai ,. Chennai TAMIL NADU kumarasamy@yrgcare. org of Committee Approval Status Date of Approval Is Independent Ethics Committee? YRGCARE Institutional Review Board, Chennai (PI - Dr Nagalingeswaran Kumarasamy) Status Approved 10/12/2011 No Date Approved/Obtained 24/04/2012 Health Type Patients Condition Type Details Intervention Stavudine (d4t) 20-mg capsules, Twice daily [BID]) Antiretroviral-Naive Patients Infected With HIV-1 Stavudine (d4t) 20-mg Oral capsules, Twice daily [BID]) A 96-week treatment Comparator Agent Tenofovir (TDF) 300 mg Tenofovir (TDF) 300 mg Oral page 2 / 5

3 Inclusion Criteria Age From Age To Gender Details Capsules, Once daily [QD] Year(s) Year(s) Both Inclusion Criteria Capsules, Once daily [QD], A 96-week treatment 1. Patient is male or female aged more than or equal to 18 years (upper limit of less than 65 years in ) 2. Patient has a documented laboratory diagnosis of infection with HIV-1 (positive enzyme-linked immunosorbent assay HIV-1 antibody test) at screening or from previous records 3. Patient has a life expectancy of more than or equal to 2 years in the opinion of the investigator 4. Patient has a plasma HIV-1 RNA level more than 1000 copies/ml 5. Patient has a plasma CD4 count less than 350 cells/mm3 using standard flow cytometry within 60 days of baseline 6. Patient has the following clinical chemistry and haematological laboratory results at screening: Serum creatinine less than or equal 1.5 mg/dl (133 micromol/l) and a calculated creatinine clearance level more than or equal 60 ml/min according to the Cockcroft-Gault formula Serum alanine aminotransferase less than 5 upper limit of normal (ULN) Serum aspartate aminotransferase less than 5 ULN Serum lipase less than or equal 1.5 ULN Total bilirubin less than or equal 1.5 mg/dl (25 micromol/l) unless felt by clinician to be due to Gilbert syndrome Haemoglobin more than or equal 7.0 g/dl Absolute neutrophil count more than or equal 500/mm3 Platelet count more than or equal /mm3 7. Female patients of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, or sexual abstinence) while participating in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit. Women Not of Childbearing Potential - Women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Women of Childbearing Potential (WOCBP) - Any female who has experienced menarche and does not meet the criteria for "Women Not of Childbearing Potential". 8. Patient has the ability to comprehend the full nature and purpose of the study, in the opinion of the investigator, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study page 3 / 5

4 9. Patient is informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study Exclusion Criteria Details Exclusion Criteria Patients meeting any of the following criteria will be excluded from the study: 1. Patients who have previously received treatment with any form of ART, including preventing mother-to-child transmission regimens 2. Patients who are taking and can not discontinue the following prohibited concomitant medications at least 1 week prior to the baseline visit and for the duration of the study period: Patients who are clinically unstable, in the investigator s opinion, should be stabilized prior to inclusion into this study and their baseline concomitant medications should be stable for at least 1 month (30 days) prior to enrolment. In addition, investigators should not anticipate changing dose levels or medications for the duration of the study. Patients who, in the investigator s opinion, require HIV-related prophylaxis (such as cotrimoxazole) and/or other HIV-related treatments (e.g. treatment for oral thrush, tuberculosis, etc) and who, in the investigator s opinion are clinically stable may have such treatment initiated or discontinued during the screening period. The 30-day waiting period will not apply to the latter. 3. Patients who have a current history of drug or alcohol abuse that, in the opinion of the investigator, may be an impediment to patient adherence to the protocol 4. Patients who have a medical history or evidence of gastrointestinal malabsorption syndrome, chronic nausea, or vomiting which may prevent patients from receiving oral medication 5. Patients who have participated in a study with an investigational drug within 60 days of screening or who are currently receiving treatment with any other investigational drug or device 6. Patients who are hepatitis B surface antigen positive 7. Patients with symptomatic peripheral neuropathies 8. Female patients who are currently pregnant or breastfeeding 9. Female patients desiring pregnancy during the next 2 years Method of Generating Random Sequence Computer generated randomization 10. Patients who have a strong likelihood of relocating far enough to make access to the study site difficult page 4 / 5

5 Powered by TCPDF ( Method of Concealment Blinding/Masking Centralized Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints The primary efficacy endpoint will be the proportion of patients with undetectable plasma HIV-1 RNA levels (less than 50 copies/ml) at Week 48. Patients who do not have a HIV-1 RNA sample taken at Week 48 will be considered as not having achieved undetectable plasma HIV-1 RNA levels (less than 50 copies/ml) at Week 48. Week 48. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial 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 Proportion of patients with plasma HIV-1 RNA levels less than 200 copies/ml at Week 96 Time to virologic failure (defined as confirmed HIV-1 RNA levels greater than or equal 1000 copies/ml at Week or greater than or equal 200 copies/ml at or after Week 24) Proportion of patients in each regimen with undetectable plasma HIV-1 RNA levels (less than 50 copies/ml) at Weeks 48 and 96 Change from baseline in plasma HIV-1 RNA levels by visit. Change from baseline in plasma CD4 levels by visit Total Sample Size=1068 Sample Size from =356 25/09/ /07/2012 Years=2 Months=0 Days=0 Open to Recruitment Open to Recruitment NA Week 96 Week Weeks 48 and 96 By visit. By visit This study aims to demonstrate the non-inferiority of a lower dose of d4t compared to TDF over 2 years of therapy, in terms of virological efficacy and early toxicity. page 5 / 5