Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial

Autor: Willem Daniel Francois, Venter, Andrew, Kambugu, Matthew F, Chersich, Stephen, Becker, Andrew, Hill, Natasha, Arulappan, Michelle, Moorhouse, Mohammed, Majam, Godspower, Akpomiemie, Simiso, Sokhela, Selvamuthu, Poongulali, Charles, Feldman, Chris, Duncombe, David H Brown, Ripin, Alinda, Vos, Nagalingeswaran, Kumarasamy
Rok vydání: 2019
Předmět:
Zdroj: Journal of Acquired Immune Deficiency Syndromes (1999)
ISSN: 1944-7884
Popis: Supplemental Digital Content is Available in the Text.
Background: Reducing doses of antiretroviral drugs, including stavudine (d4T), may lower toxicity, while preserving efficacy. There are substantial concerns about renal and bone toxicities of tenofovir disoproxil fumarate (TDF). Setting: HIV-1–infected treatment-naive adults in India, South Africa, and Uganda. Methods: A phase-4, 96-week, randomized, double-blind, noninferiority trial compared d4T 20 mg twice daily and TDF, taken in combination with lamivudine (3TC) and efavirenz (EFV). The primary endpoint was the proportion of participants with HIV-1 RNA
Databáze: OpenAIRE