This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA \< 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
Kaiser Permanente Los Angeles
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc
Los Angeles, California, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Central Texas Clinical Research
Austin, Texas, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, United States
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12
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 12
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities
This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.
Time frame: Up to 48 weeks plus 30 days
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 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: Weeks 24 and 48
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