The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
872
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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 With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient'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: Weeks 48 and 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
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time frame: Baseline; Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablet administered orally once daily
University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States
University of Southern California AIDS Clinical Trials Group
Los Angeles, California, United States
Peter J. Ruane, Inc.
Los Angeles, California, United States
Anthony Mills MD Inc
Los Angeles, California, United States
Alameda County Medical Center
Oakland, California, United States
Stanford University
Palo Alto, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
...and 107 more locations
Percent Change From Baseline in Hip BMD at Week 96
Hip BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 96
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline; Week 48
Change From Baseline in Serum Creatinine at Week 96
Time frame: Baseline; Week 96
Percentage of Participants With Treatment-emergent Proteinuria Through Week 48
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time frame: Baseline to Week 48
Percentage of Participants With Treatment-emergent Proteinuria Through Week 96
Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.
Time frame: Baseline to Week 96
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 48
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 96
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 48
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 96