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

Completed · Phase 1

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID

NCT03960645

Run by

Gilead Sciences

People needed

62

Starts

2019-06-28

Expected to finish

2022-08-18

Last updated by the study team

2024-06-14

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

Where it is running

• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
• Instituto Dominicano de Estudios Virologics (IDEV) — Santo Domingo, Dominican Republic
• Faculty of Medicine Siriraj Hospital — Bangkok Noi, Thailand
• Faculty of Medicine-Khon Kaen University — Khon Kaen, Thailand
• Bamrasnaradura Infectious Diseases Institute — Nonthaburi, Thailand
• Research Institute for Health Sciences, Chiang Mai University — Nonthaburi, Thailand
• Thai Red Cross AIDS Research Centre — Pathumwan, Thailand

Full record on ClinicalTrials.gov

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