NCT07055451

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Neonates Exposed to HIV-1

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 120 Hours
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	Tablet for oral suspension administered

Timeline

• Start date: 2025-08-12
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-07-09
• Last updated: 2026-04-15

Locations

7 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study