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

Gilead Sciences

Status and phase: Enrolling; Phase 1

Conditions: HIV-1-infection

Treatments: Drug: B/F/TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT07055451

GS-US-380-5578

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: Under 120 hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cohort 1: Group A of B/F/TAF

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF

Cohort 1: Group B of B/F/TAF

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF