Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

• Status: Completed
• Trial end date: 2019-10-23
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Dolutegravir; Emtricitabine; Emtricitabine tenofovir alafenamide; Lamivudine; Tenofovir; Triumeq

Criteria

Key Inclusion 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 Exclusion Criteria:

• 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.