Efficacy and safety of tenofovir disoproxil fumarate versus low-dose stavudine over 96 weeks: a multi-country randomised, non-inferiority trial

BACKGROUNDReducing 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 METHODSA phase-4, 96-week, randomized, double-blind, non-inferiority trial compared d4T 20mg BD and TDF, taken in combination with lamivudine (3TC) and efavirenz (EFV). The primary endpoint was the proportion of participants with HIV-1 RNA