Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Lead Sponsor

Gilead Sciences

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)
•Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
•Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
•Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
•CD4+ cell count ≥ 200 cells/µL at screening

•A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol
•Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
•Chronic hepatitis B virus (HBV) infection
•Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
•Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
•Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial