Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naïve Adults

• Status: Completed
• Trial end date: 2021-07-02
• Target enrollment: 0
• Participant gender: All

Summary

The 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 a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Abacavir; Dolutegravir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Tenofovir; Triumeq

Criteria

Key Inclusion Criteria:

• Antiretroviral treatment naïve (≤ 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 RNA levels ≥ 500 copies/mL at screening

• Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula

• Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences

Key Exclusion Criteria:

• An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)

• Decompensated cirrhosis (e.g, 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

• Chronic Hepatitis B Virus (HBV) infection

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