Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
Purpose
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.
Condition
- HIV-1-infection
Eligibility
- Eligible Ages
- Under 120 Hours
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1: Group A of B/F/TAF |
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. |
|
|
Experimental Cohort 1: Group B of B/F/TAF |
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. |
|
Recruiting Locations
Los Angeles 5368361, California 5332921 90095
Atlanta 4180439, Georgia 4197000 30322
Memphis 4641239, Tennessee 4662168 38105
More Details
- Status
- Recruiting
- Sponsor
- Gilead Sciences
Study Contact
Gilead Clinical Study Information Center1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com