Safety and Efficacy of Bictegravir/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.
This research study is led by Dr. Durane Walker.
November 03, 2015
Baystate Infectious Diseases Clinical Research,
3300 Main Street,
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
- 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
- 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.
Interventional (Clinical Trial), Randomized