Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

NCT00112047 ↗

Phase 3 Completed 517 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2003-07
Primary completion: 2005-02
Completion: 2009-06

Outcome

Met primary endpoint

registry EFV+FTC/TDF vs CBV+EFV; p = 0.002; Difference in percentages 11.4 (95% CI 4.3 to 18.6) NCT00112047 ↗

paper significantly more patients in the tenofovir-emtricitabine group reached and maintained the primary end point PMID 16421366 ↗

release “show a statistically significant difference favoring Viread/Emtriva in the percentage of patients who achieved and maintained HIV RNA less than 400 copies/mL at 48 weeks” gilead.com ↗

Publications

Results Gallant JE, DeJesus E, Arribas JR, Pozniak AL, Gazzard B, Campo RE, Lu B, McColl D, Chuck S, Enejosa J, Toole JJ, Cheng AK; Study 934 Group. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006 Jan 19;354(3):251-60. doi: 10.1056/NEJMoa051871.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavirenz	Other / unclassified	600 mg	—
Subject	FTC/TDF	Unknown	200 mg	—
Subject	FTC/TDF	Unknown	300 mg	—
Subject	FTC/TDF/EFV	Unknown	200 mg	—
Subject	FTC/TDF/EFV	Unknown	300 mg	—
Subject	FTC/TDF/EFV	Unknown	600 mg	—
Comparator	Lamivudine/zidovudine	Unknown	150 mg	—
Comparator	Lamivudine/zidovudine	Unknown	300 mg	—
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	—
Subject	emtricitabine	Other / unclassified	200 mg	—