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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

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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

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

Trial documents
7

Trial contacts and locations

125

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Data sourced from clinicaltrials.gov

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