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) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
85
Cobicistat (COBI) 150 mg tablet administered orally once daily
Ritonavir (RTV) 100 mg soft gelatin capsule administered orally once daily
Atazanavir (ATV) 300 mg capsule administered orally once daily
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
Placebo to match COBI administered orally once daily
Placebo to match RTV administered orally once daily
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States
AIDS Healthcare Foundation-Research Center
Beverly Hills, California, United States
The Living Hope Foundation
Long Beach, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the missing = failure method.
Time frame: Week 48
Change From Baseline in HIV-1 RNA at Week 24
The change from baseline in log\_10 HIV-1 RNA at Week 24 was analyzed.
Time frame: Baseline to Week 24
Change From Baseline in HIV-1 RNA at Week 48
The change from baseline in log\_10 HIV-1 RNA at Week 48 was analyzed.
Time frame: Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 24
The change from baseline in CD4 cell count at Week 24 was analyzed.
Time frame: Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
The change from baseline in CD4 cell count at Week 48 was analyzed.
Time frame: Baseline to Week 48
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Orange Coast Medical Group
Newport Beach, California, United States
David J. Shamblaw, MD Inc.
San Diego, California, United States
Metropolis Medical
San Francisco, California, United States
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
...and 21 more locations