D4T
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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · OPP1032239
interventional
1,077
3 countries
3
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2015
Actual (reported)The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)December 2015
Actual (reported)January 22, 2016
Actual (reported)February 2, 2016
Actual (reported)Number of participants with undetectable plasma HIV-1 RNA levels
Week 48
Number of participants with adverse events related to treatment
Week 48
Number of patients with plasma HIV-1 RNA levels <200 copies
Week 96
Number of participants with abnormal Bone mineral density and fat distribution
Week 96
Number of participants with abnormal Bone mineral density.
Week 96
Number of participants with abnormal fat distribution
Week 96
Stavudine 20mg twice daily for 96 weeks
Tenofovir 300mg once daily for 96 weeks
Stavudine 20mg twice daily for 96 weeks + Placebo 300mg once daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks
TDF 300mg once daily + Placebo 20mg twice daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks
VHS-YRG Care Medical Centre
Chennai, Tamil Nadu, 600113, India
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2196, South Africa
The Infectious Disease Institute (IDI), Mulago Hospital Complex
Kampala, Kampala, 25641, Uganda
Draaijer M, Lalla-Edward ST, Venter WDF, Vos A. Phone Calls to Retain Research Participants and Determinants of Reachability in an African Setting: Observational Study. JMIR Form Res. 2020 Sep 30;4(9):e19138. doi: 10.2196/19138.
Venter WDF, Kambugu A, Chersich MF, Becker S, Hill A, Arulappan N, Moorhouse M, Majam M, Akpomiemie G, Sokhela S, Poongulali S, Feldman C, Duncombe C, Ripin DHB, Vos A, Kumarasamy N. Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019 Feb 1;80(2):224-233. doi: 10.1097/QAI.0000000000001908.
Francois Venter, FCP (SA)
Wits Reproductive Health & HIV Institute
1,077 participants (actual enrollment reported by the registry).
First Submitted
January 22, 2016
First Posted
February 2, 2016
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Vos AG, Chersich MF, Klipstein-Grobusch K, Zuithoff P, Moorhouse MA, Lalla-Edward ST, Kambugu A, Kumarasamy N, Grobbee DE, Barth RE, Venter WD. Lipid levels, insulin resistance and cardiovascular risk over 96 weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir. Retrovirology. 2018 Dec 14;15(1):77. doi: 10.1186/s12977-018-0460-z.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
February 2, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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