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Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07055451•Gilead Sciences

View on ClinicalTrials.gov

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

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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.
•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

•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.
•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.

Locations (7)

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

Key Dates

Start Date

August 12, 2025

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

HIV-1-infection

Interventions

B/F/TAF

DRUG

Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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