Conditions: Infection, Human Immunodeficiency Virus I HIV Infection
Keywords: tenofovir HIV efavirenz naive lamivudine abacavir emtricitabine renal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 392
Healthy volunteers: no

Brief summary:
Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens. However data from head-to-head randomized trials comparing these two FDCs as part of an initial regimen are not available at present. The long-term toxicity profiles of these regimens are of particular importance, as treatment of HIV is currently life-long and therefore, minimizing long-term toxicity and maximizing adherence and duration of regimen maintenance are critical therapy objectives.

The primary endpoint is estimated glomerular filtration rate (GFR), as measured by the modified diet in renal disease (MDRD) equation, a validated estimate of renal function.

Detailed description:
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Abacavir/lamivudine and efavirenz intervention 2: Tenofovir/Emtricitabine and efavirenz
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: