Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Phase 3

Completed

Conditions: HIV-1-infection

Interventions: Drug: B/F/TAF
Drug: F/TAF
Drug: DTG Placebo
Drug: DTG
Drug: F/TAF Placebo
Drug: B/F/TAF Placebo

Registration Number: NCT03110380

Lead Sponsor: Gilead Sciences

Brief Summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 567

Inclusion Criteria

Currently receiving an ARV regimen of DTG+F/TAF or DTG+F/TDF for the following minimum time periods:
- ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance prior to the screening visit)
- ≥ 3 months (if there is no documented or suspected NRTI resistance prior to the screening visit)
Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL during treatment with DTG+F/TAF or DTG+F/TDF (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit
Plasma HIV-1 RNA levels < 50 copies/mL at screening visit
Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
No documented resistance to integrase stand transfer inhibitors (INSTIs) or confirmed virologic failure
Eligible adults with chronic hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection are permitted to enroll

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B/F/TAF	F/TAF Placebo	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks.
B/F/TAF	B/F/TAF	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks.
DTG + F/TAF	B/F/TAF Placebo	DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.
B/F/TAF	DTG Placebo	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet + dolutegravir (DTG) placebo tablet + emtricitabine/tenofovir alafenamide (F/TAF) placebo tablet administered without regard to food for at least 48 weeks.
Open-label Phase B/F/TAF from B/F/TAF	B/F/TAF	Participants who received B/F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
Open-label Phase B/F/TAF from DTG + F/TAF	B/F/TAF	Participants who received DTG + F/TAF in double-blind phase and from a country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
DTG + F/TAF	F/TAF	DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.
DTG + F/TAF	DTG	DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	Week 48	The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	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 participant'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.
Change From Baseline in CD4+ Cell Count at Week 48	Baseline; Week 48

Trial Locations

Locations (92): Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Ruane Clinical Research Group Inc.
🇺🇸
Los Angeles, California, United States
Mills Clinical Research
🇺🇸
Los Angeles, California, United States
Highland Hospital - Alameda Health System
🇺🇸
Oakland, California, United States
Cares Community Health
🇺🇸
Sacramento, California, United States
Kaiser Permanente
🇺🇸
San Francisco, California, United States
Hepatitis/HIV Clinical Trials Group (HHCTG)
🇺🇸
San Francisco, California, United States
Kaiser Permanente, Department of Infectious Diseases
🇺🇸
San Leandro, California, United States
University of Colorado Denver, University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Whitman-Walker Institute
🇺🇸
Washington, District of Columbia, United States
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Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States