The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
583
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
Time frame: Baseline; Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 96
Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Open-Label Extension Week 48
Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
Time frame: Baseline; Open-Label Extension Week 48
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200/300 mg tablet administered orally with food once daily
Tablet administered orally with food once daily
Tablet administered orally with food once daily
Capsule administered orally with food once daily
Tablet administered orally with food once daily
150/150/200/10 mg FDC tablet administered orally with food once daily
University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
IDOCF/ValuhealthMD
Orlando, Florida, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
...and 89 more locations