A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.
Inclusion Criteria:
Exclusion Criteria:
Denver, California 80209, United States
Los Angeles, California 90028, United States
San Francisco, California 94118, United States
Washington D.C., District of Columbia 20037, United States
Tampa, Florida 33602, United States
St Louis, Missouri 63110, United States
Philadelphia, Pennsylvania 19107, United States
Dallas, Texas 75204, United States
Annandale, Virginia 22003, United States
Darlinghurst, New South Wales 2010, Australia
Carlton, Victoria 3053, Australia
Vienna, 1090, Austria
Winnipeg, Manitoba R3A 1R9, Canada
Frankfurt am Main, 60590, Germany
Guadalajara, Jalisco 44280, Mexico