STATUS Recruitment Complete

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-380-5578

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

August 26, 2026

Clinicaltrials.gov ID

NCT07055451

OVERVIEW

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

PROTOCOL 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.

Participation requirements

Age

0 - 120 Hours

Sex

All

Healthy Volunteers

Study details

Medical Condition

HIV-1-infection

Gender

N/A

Date

August 2025 - March 2028

Study Type

Interventional

Study Phase

Phase 1

Product

B/F/TAF

Eligibility information

Inclusion criteria

Mother inclusion criteria:
Be on standard of care (SOC) antiretroviral therapy for human immunodeficiency virus type 1 (HIV-1) treatment.
Have confirmed HIV-1 infection based on positive test results obtained from medical records.
Neonate inclusion criteria:
Be born at term (≥ 37.0 weeks gestational age).
Be able to take oral medication.
Be ≤ 120 hours of life at enrollment.
Have a birth weight ≥ 2.5 kg.
Is receiving or plans to receive HIV-1 SOC prophylaxis regimen with 1 antiretroviral (ARV) to prevent perinatal transmission.

Exclusion criteria

Mother exclusion criteria:
Has a maternal-fetal blood group incompatibility identified by clinically relevant antibody that can cause hemolytic diseases of the neonate.
Is breastfeeding or plans to breastfeed while on bictegravir (BIC) or emtricitabine (FTC) containing regimen. Mothers on BIC or FTC containing regimen, but not breastfeeding, can be enrolled in the study.
Neonate exclusion criteria:
Had prior or expected to require blood exchange transfusion.
Is receiving or plans to receive any component of B/F/TAF or dolutegravir as part of their SOC ARV prophylaxis regimen.
Has a documented positive HIV-1 nucleic acid test.
Has Grade 2 or higher aspartate aminotransferase, total bilirubin, hemoglobin, platelets or creatinine. Has Grade 1 or higher alanine aminotransferase.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.