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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
698
Cobicistat (COBI) 150 mg tablet administered orally once daily
Ritonavir (RTV) 100 mg tablet 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
University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, United States
Living Hope Clinical Foundation
Long Beach, California, United States
Kaiser Permanente
Los Angeles, California, United States
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 snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.
Time frame: Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.
Time frame: Week 144
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.
Time frame: Week 192
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline to Week 48
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline to Week 96
Change From Baseline in CD4 Cell Count at Week 144
Time frame: Baseline to Week 144
Change From Baseline in CD4 Cell Count at Week 192
Time frame: Baseline to Week 192
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