Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Completed · Phase 3
Conditions studied: HIV Infections
In brief
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) \< 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.
Key facts
- Study ID
- NCT00112047
- Run by
- Gilead Sciences
- People needed
- 517
- Starts
- 2003-07-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2010-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- AIDS Healthcare Foundation Research — Beverly Hills, California, United States
- Capital Medical Associates, P.C. — Washington D.C., District of Columbia, United States
- Orlando Immunology Center — Orlando, Florida, United States
- NorthStar Medical Center — Chicago, Illinois, United States
- Jemsek Clinic — Huntersville, North Carolina, United States
Full record on ClinicalTrials.gov
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