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

NCT07055451 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GS-US-380-5578
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth

  First dose date up to 8 Weeks

• Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth

  First dose date up to 8 Weeks

• Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf

  AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.

  Predose up to 72 hours postdose

• PK parameters for BIC: AUClast

  AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.

  Predose up to 72 hours postdose

• PK parameters for BIC: AUC0-24h

  AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 hours.

  Predose up to 24 hours postdose

• PK parameters for BIC: Cmax

  Cmax is defined as the maximum observed concentration of drug.

  Predose up to 72 hours postdose

• PK parameters for BIC: Tmax

  Tmax is defined as the time (observed time point) of Cmax.

  Predose up to 72 hours postdose

• PK parameters for BIC: Cmin

  Cmin is defined as the minimum observed concentration of drug.

  Predose up to 72 hours postdose

• PK parameters for BIC: C24h

  C24h is defined as the concentration of drug at time 24 hours.

  At 24 hours postdose

• PK parameters for BIC: t1/2

  t1/2 is defined as the terminal elimination half-life.

  Predose up to 72 hours postdose

• PK parameters for BIC: Apparent CL/F

  Apparent CL/F is defined as the apparent total body clearance for extravascular administration.

  Predose up to 72 hours postdose

• PK parameters for BIC: Apparent Vz/F

  Apparent Vz/F is defined as the apparent volume of distribution based on the terminal phase.

  Predose up to 72 hours postdose

Secondary Outcomes (12)

• PK Parameters for Emtricitabine (FTC), and Tenofovir (TFV): AUCinf

  Predose up to 72 hours postdose

• PK parameters for FTC, TAF, and TFV: AUClast

  Predose up to 72 hours postdose

• PK parameters for FTC, TAF, and TFV: AUC0-24h

  Predose up to 24 hours postdose

• PK parameters for FTC, TAF, and TFV: Cmax

  Predose up to 72 hours postdose

• PK parameters for FTC, TAF, and TFV: Tmax

  Predose up to 72 hours postdose

Study Arms (2)

Cohort 1: Group A of B/F/TAF

EXPERIMENTAL

Full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group A to evaluate a different pharmacokinetic (PK) sampling scheme than Cohort 1 Group B. Neonate participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3.

Drug: B/F/TAF

Cohort 1: Group B of B/F/TAF

EXPERIMENTAL

Once enrollment in Cohort 1 Group A is completed, full-term neonate participants, who are exposed to HIV-1 but uninfected, with a weight of ≥ 2.5 kg at birth and their mothers will be assigned to Cohort 1 Group B to evaluate a different PK sampling scheme than Cohort 1 Group A. Participants will receive a single dose of B/F/TAF fixed-dose combination 1.88/7.5/0.94 mg tablet for oral suspension administered along with 1 antiretroviral as standard of care postnatal prophylaxis at both Visits 1 and 3.

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

Tablet for oral suspension administered

Cohort 1: Group A of B/F/TAF; Cohort 1: Group B of B/F/TAF

Eligibility Criteria

• Age: Up to 120 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (7)

Ronald Reagan UCLA Medical Center (inpatient hospital)

Los Angeles, California, 90095, United States

Location

Grady Health System - Ponce de Leon Center

Atlanta, Georgia, 30308, United States

Location

St Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Family Centre for Research with Ubuntu (FAMCRU)

Cape Town, 7505, South Africa

Location

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, 4013, South Africa

Location

Perinatal HIV Research Unit (PHRU)

Gauteng, 1864, South Africa

Location

WITS RHI Shandukani Research Centre

Johannesburg, 2001, South Africa

Location

Related Links

• Gilead Clinical Trials Website

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 9, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); ZA (4)