Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Recruiting in Palo Alto (17 mi)
+133 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Gilead Sciences
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Inclusion Criteria
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
+7 more
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ATV+COBI+FTC/TDFExperimental Treatment4 Interventions
COBI + RTV placebo + ATV + FTC/TDF once daily
Group II: ATV+RTV+FTC/TDFActive Control4 Interventions
RTV + COBI placebo + ATV + FTC/TDF once daily
Atazanavir is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Reyataz for:
- HIV-1 infection
🇪🇺 Approved in European Union as Reyataz for:
- HIV-1 infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Metropolis MedicalSan Francisco, CA
Dupont Circle Physicians GroupWashington, United States
Whitman-Walker ClinicWashington, United States
Infectious Disease Specialists of AtlantaDecatur, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Gilead SciencesLead Sponsor