Overview

KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Recently, the fixed-dose combinations (FDC) KIVEXAâ„¢ (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.
Phase:
Phase 4
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Abacavir
Efavirenz
Emtricitabine
Lamivudine
Tenofovir