This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
668
200/300 mg FDC tablets administered orally once daily
Tablets administered orally once daily
An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).
Tablets administered orally once daily
Tablets administered orally once daily
University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Tarrant County ID Associates
Los Angeles, California, United States
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 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
Percentage Change From Baseline in Spine BMD at Week 48
Spine BMD was assessed by DXA scan.
Time frame: Baseline; Week 48
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis
The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 Change From Baseline in Hip BMD at Week 96
Hip BMD was assessed by DXA scan.
Time frame: Baseline; Week 96
Percentage 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 CD4+ Cell Count at Week 96
Time frame: Baseline; Week 96
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Southern California Men's Medical Group
Los Angeles, California, United States
Highland Hospital - Alameda Health System (formerly Alameda County medical Center)
Oakland, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Kaiser Permanente Medical Group San Francisco
San Francisco, California, United States
...and 68 more locations