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. 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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Stribild
- drug : Stribild
- drug : ATV/r + FTC/TDF
Phase: Phase 3
Ages Eligible For Study:
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Plasma HIV-1 RNA levels ? 5,000 copies/mL at screening - No prior use of any approved or investigational antiretroviral drug for any length of time - Screening genotype report must show sensitivity to FTC, TDF, and ATV - Normal electrocardiogram (ECG) - Adequate renal function (estimated glomerular filtration rate ? 70 mL/min according to the Cockcroft Gault formula) - Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ? 5 x the upper limit of the normal range (ULN) - Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ? 5 x ULN - Males and Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug - Age ? 18 years - Life expectancy ? 1 year