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) FDC in HIV-1 positive, antiretroviral treatment-naive adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
872
Percentage of Participants With 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 Weeks 96 and 144
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Weeks 96 and 144 were 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 96 and 144
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Weeks 48, 96, and 144 were 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, 96. and 144
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
Change From Baseline in CD4+ Cell Count at Week 144
Time frame: Baseline; Week 144
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
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Tablet administered orally once daily
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Kaiser Permanente Los Angeles
Los Angeles, California, United States
University of California, 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
East Bay AIDS Center
Oakland, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
University of California, San Diego
San Diego, California, United States
...and 107 more locations
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Time frame: Baseline; Week 48
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 Hip BMD at Week 144
Hip BMD was assessed by DXA scan.
Time frame: Baseline; Week 144
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
Percent Change From Baseline in Spine BMD at Week 144
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 144
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
Change From Baseline in Serum Creatinine at Week 144
Time frame: Baseline; Week 144
Percentage of Participants Experiencing 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: Up to 48 weeks
Percentage of Participants Experiencing 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: Up to 96 weeks
Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144
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: Up to 144 weeks
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 RBP to Creatinine Ratio at Week 144
Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 144
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
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144
Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.
Time frame: Baseline; Week 144