NCT03960645

Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the steady state PK of bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed pregnant women in their second and third trimesters.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	50/200/25 mg FDC tablet administered orally once daily without regard to food.

Timeline

• Start date: 2019-06-28
• Primary completion: 2022-07-21
• Completion: 2022-08-18
• First posted: 2019-05-23
• Last updated: 2024-06-14
• Results posted: 2024-05-28

Locations

8 sites across 3 countries: United States, Dominican Republic, Thailand

Regulatory

• FDA-regulated drug study