CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 698 enrolled
Drug / intervention
COBI +5 moredrug
Likely dose
COBI 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01108510
NCT01108510Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences·interventional·Posted Apr 22, 2010·Updated May 23, 2016

In Brief

A Phase 3 clinical trial evaluating COBI, RTV, and 4 other interventions for HIV and HIV Infections. Completed, enrolled 698 participants across 134 sites in 19 countries.

Detailed Summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Infections
CountriesAustralia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Switzerland, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2010
Enrollment StartApr 1, 2010
Primary CompletionNov 1, 2011
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.2 years ago

Interventions

COBIdrug

Cobicistat (COBI) 150 mg tablet administered orally once daily

RTVdrug

Ritonavir (RTV) 100 mg tablet administered orally once daily

ATVdrug

Atazanavir (ATV) 300 mg capsule administered orally once daily

FTC/TDFdrug

Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily

COBI placebodrug

Placebo to match COBI administered orally once daily

RTV placebodrug

Placebo to match RTV administered orally once daily