Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV (NCT07055451) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
United States, South Africa16 participantsStarted 2025-08-12
Plain-language 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.
Who can participate
Age range
120 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on safety and how the drug behaves in newborns' bodies rather than proving it works, what does that mean for the level of uncertainty my baby might be exposed to compared to existing standard newborn HIV prevention options?
2The trial is actively enrolling but no longer recruiting — does that mean my newborn would not be eligible to join, and if so, are there other similar studies we should look into?
3The study is measuring side effects and lab abnormalities through the first 8 weeks of life — what kinds of adverse events or lab changes are most concerning in newborns taking HIV medications, and how would those be monitored and managed?
4This combination drug, bictegravir/emtricitabine/tenofovir alafenamide, is already used in adults and older children — what is currently known about how safe and appropriate the dosing might be for newborns specifically, given that this trial is partly designed to figure that out?
5If my baby were to participate in a study like this, what would the visit schedule, blood draw requirements, and other demands look like during those first 8 weeks, and how would that compare to what standard newborn HIV prophylaxis would require anyway?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAs) Though Week 8 After Neonate Birth
Timeframe: First dose date up to 8 Weeks
2
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities Through Week 8 After Neonate Birth
Timeframe: First dose date up to 8 Weeks
3
Pharmacokinetic (PK) parameters for Bictegravir (BIC): AUCinf