At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Stribild, ATV, and 6 other interventions for HIV and HIV Infections. Completed, enrolled 708 participants across 146 sites in 17 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
Atazanavir 300 mg capsule administered orally once daily
Ritonavir (RTV; /r) 100 mg tablet administered orally once daily
FTC/TDF 200/300 mg tablet administered orally once daily
Placebo to match Stribild administered orally once daily
Placebo to match ATV administered orally once daily
Placebo to match RTV administered orally once daily
Placebo to match FTC/TDF administered orally once daily