Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02607956

2015-003988-10 (EudraCT Number)

GS-US-380-1490

Details and patient eligibility

About

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.

Enrollment: 657 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
• Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
• Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

• An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
• Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
• Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
• Females who are pregnant (as confirmed by positive serum pregnancy test)
• Females who are breastfeeding

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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657 participants in 4 patient groups

B/F/TAF

Experimental group

Description:

B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.

Treatment:

Drug: F/TAF Placebo

Drug: DTG Placebo

Drug: B/F/TAF

DTG + F/TAF

Active Comparator group

Description:

DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.

Treatment:

Drug: F/TAF

Drug: B/F/TAF Placebo

Drug: DTG

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

Experimental group

Description:

After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Treatment:

Drug: B/F/TAF

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

Experimental group

Description:

After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Treatment:

Drug: B/F/TAF