Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
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.
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 RNA levels ≥ 500 copies/mL at screening

 -  Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50
 mL/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.