Dose Optimisation of Stavudine for the Treatment of HIV Infection

Summary

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.

Timeline

Start

2012-07

Primary completion

2014-12

Completion

2015-12

Publications

• 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.
• 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.

Drugs

Indications