RecruitingPhase 1NCT07055451

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

Sponsor

Gilead Sciences

Enrollment

16 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

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.

Eligibility

Max Age: 120 Hours

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug HIV prevention pill — bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) — in newborns whose mothers are living with HIV, to see if it is safe and effective at preventing the baby from acquiring HIV during or around birth. Newborns at risk of HIV currently have limited medication options. **You may be eligible if...** - Your newborn was born to a mother living with HIV - Your baby was born at full term (37 weeks or later) with a birth weight of at least 2.5 kg - Your baby is less than 120 hours (5 days) old at enrollment - Your baby is able to take oral medication - Your baby is already receiving or will receive the standard HIV prevention treatment after birth **You may NOT be eligible if...** - Your baby is premature (born before 37 weeks) - Your baby needs a blood exchange transfusion - Your baby is already receiving B/F/TAF or dolutegravir as part of standard care - You are breastfeeding while taking bictegravir or emtricitabine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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