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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: HIV-1-infection

Treatments: Drug: B/F/TAF; Drug: F/TAF; Drug: B/F/TAF Placebo; Drug: DTG Placebo; Drug: F/TAF Placebo; Drug: DTG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03110380

2017-000308-17 (EudraCT Number)

GS-US-380-4030

Details and patient eligibility

About

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.

Enrollment: 567 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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567 participants in 4 patient groups

B/F/TAF

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF

Drug: F/TAF Placebo

Drug: DTG Placebo

DTG + F/TAF

Active Comparator group

Description:

DTG 50 mg tablet + F/TAF FDC tablet + B/F/TAF placebo tablet administered without regard to food for at least 48 weeks.

Treatment:

Drug: DTG

Drug: F/TAF

Drug: B/F/TAF Placebo

Open-label Phase B/F/TAF from B/F/TAF

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF

Open-label Phase B/F/TAF from DTG + F/TAF

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF