NCT03797014

B/F/TAF Switch Study for HIV-HBV Coinfection

Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.

Conditions

• HIV-1-infection
• Hepatitis B

Interventions

Type	Name	Description
DRUG	B/F/TAF	Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.

Timeline

• Start date: 2019-04-30
• Primary completion: 2022-11-22
• Completion: 2023-05-05
• First posted: 2019-01-08
• Last updated: 2023-11-03
• Results posted: 2023-07-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study