A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of switching from a regimen
of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of
abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of
bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC
as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1)
infected adults.
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
- Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
- HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.
- Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
- Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC. Key
- Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
- Active tuberculosis infection.
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- Females who are pregnant.
- Females who are breastfeeding.
- Acute hepatitis in the 30 days prior to study entry.
- Chronic Hepatitis B Virus (HBV) infection. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Powered by
SC CTSI