NCT00549198

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

Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection, Human Immunodeficiency Virus I
• HIV Infection

Interventions

Type	Name	Description
DRUG	Abacavir/lamivudine and efavirenz
DRUG	Tenofovir/Emtricitabine and efavirenz

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-10-25
• Last updated: 2011-04-12
• Results posted: 2010-10-15

Locations

68 sites across 13 countries: Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Latvia, Netherlands, Portugal, Spain, Switzerland, United Kingdom