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



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/20/2018
Start Date:November 13, 2015
End Date:August 2020

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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

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.


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*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.
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