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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infection

Treatments: Drug: B/F/TAF Placebo; Drug: ABC/DTG/3TC; Drug: B/F/TAF; Drug: ABC/DTG/3TC Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02603120

GS-US-380-1844

2015-004025-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 567 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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567 participants in 3 patient groups

Blinded Phase: B/F/TAF

Experimental group

Description:

B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks

Treatment:

Drug: ABC/DTG/3TC Placebo

Drug: B/F/TAF

Blinded Phase: ABC/DTG/3TC

Active Comparator group

Description:

ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks

Treatment:

Drug: B/F/TAF Placebo

Drug: ABC/DTG/3TC

Open-Label Phase

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF