The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,443
150/150/200/10 mg FDC tablet administered orally once daily
150/150/200/300 mg FDC tablet administered orally once daily
600/200/300 mg FDC tablet administered orally once daily
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
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. BMD is calculated as grams per square centimeter (g/cm\^2); the mean (SD) percentage change is presented.
Time frame: Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan. BMD is calculated as g/cm\^2; the mean (SD) percentage change is presented.
Time frame: Baseline; Week 48
Change From Baseline in Serum Creatinine at Week 48
Time frame: Baseline; Week 48
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement. EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit.
Time frame: Baseline; Week 48
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100 mg tablet administered orally once daily
300 mg capsule administered orally once daily
200/300 mg tablet administered orally once daily
150 mg tablet administered orally once daily
University of Alabama at Birmingham
Birmingham, Alabama, United States
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, United States
AHF Research Center
Beverly Hills, California, United States
Michael Keith Wensley, MD, Inc., A Medical Corporation
Costa Mesa, California, United States
Living Hope Clinical Foundation
Long Beach, California, United States
Kaiser Permanente
Los Angeles, California, United States
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States
Peter J Ruane, MD, Inc
Los Angeles, California, United States
...and 157 more locations
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 Week 48
The percentage of participants achieving HIV-1 RNA \< 20 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 < 20 Copies/mL at Week 96
The percentage of participants achieving HIV-1 RNA \< 20 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
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time frame: Baseline; Week 48
Change From Baseline in CD4 Cell Count at Weeks 96
The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen.
Time frame: Baseline; Week 96