Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
Running, not enrolling · Phase 1
Conditions studied: HIV-1-infection
In brief
The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) in neonates exposed to human immunodeficiency virus type 1 (HIV-1). The primary objective of this study is to evaluate the safety and plasma pharmacokinetics (PK) (how B/F/TAF is absorbed, modified, distributed, and removed from the body of the participants) of B/F/TAF tablet for oral suspension (TOS) in full-term neonates exposed to HIV-1 but uninfected.
Key facts
- Study ID
- NCT07055451
- Run by
- Gilead Sciences
- People needed
- 16
- Starts
- 2025-08-12
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ronald Reagan UCLA Medical Center (inpatient hospital) — Los Angeles, California, United States
- Grady Health System - Ponce de Leon Center — Atlanta, Georgia, United States
- St Jude Children's Research Hospital — Memphis, Tennessee, United States
- Family Centre for Research with Ubuntu (FAMCRU) — Cape Town, South Africa
- Durban International Clinical Research Site, Enhancing Care Foundation — Durban, South Africa
- Perinatal HIV Research Unit (PHRU) — Gauteng, South Africa
- WITS RHI Shandukani Research Centre — Johannesburg, South Africa
Full record on ClinicalTrials.gov
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