Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

Phase 3

Completed

• Conditions: HIV-1 Infection
• Interventions: Drug: B/F/TAF; Drug: ABC/DTG/3TC; Drug: ABC/DTG/3TC Placebo; Drug: B/F/TAF Placebo

• Registration Number: NCT02603120
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study Start: 2015-11-11
• Study First Posted: 2015-11-11
• Primary Completion: 2017-05-09
• Results First Submitted: 2018-05-01
• Results First Submitted QC: 2018-06-25
• Results First Posted: 2018-07-23
• Study Completion: 2019-10-23
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

• Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
• Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
• HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.
• Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
• Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key

Exclusion Criteria

• Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
• Active tuberculosis infection.
• Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
• Females who are pregnant.
• Females who are breastfeeding.
• Acute hepatitis in the 30 days prior to study entry.
• Chronic Hepatitis B Virus (HBV) infection.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded Phase: B/F/TAF	B/F/TAF	B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
Blinded Phase: B/F/TAF	ABC/DTG/3TC Placebo	B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
Blinded Phase: ABC/DTG/3TC	ABC/DTG/3TC	ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
Blinded Phase: ABC/DTG/3TC	B/F/TAF Placebo	ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
Open-Label Phase	B/F/TAF	At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified 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.

Secondary Outcome Measures

Name	Time	Method
Spine Bone Mineral Density (BMD) at Baseline	Baseline
Percentage Change From Baseline in Spine BMD at Week 48	Baseline; Week 48
Hip Bone Mineral Density at Baseline	Baseline
Percentage Change From Baseline in Hip BMD at Week 48	Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 48	Baseline; Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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.