This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
438
PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)
RTV administered according to prescribing information FTC/TDF administered according to prescribing information
FTC/TDF (200/300 mg) administered according to prescribing information
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
Spectrum Medical Group
Phoenix, Arizona, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
AIDS Healthcare Foundation
Beverly Hills, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Time frame: Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Time frame: Week 96
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96
Time frame: Baseline; Week 96
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Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, M.D., Inc.
Los Angeles, California, United States
OASIS Clinic
Los Angeles, California, United States
Anthony Mills MD Inc
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
...and 89 more locations