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NCT07055451 · ClinicalTrials.gov registry record · Phase 1
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
A Phase 1 study of HIV-1-infection, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 7
- Study locations
NCT07055451: Recruiting Phase 1 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT07055451 is a Phase 1 study of HIV-1-infection that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 16 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07055451, a Phase 1 study of HIV-1-infection, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 7
- Study locations
Study 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 Studied
Interventions
- DRUG B/F/TAF
Study Locations (7)
Other
- Family Centre for Research with Ubuntu (FAMCRU) - Cape Town
- Durban International Clinical Research Site, Enhancing Care Foundation - Durban
- Perinatal HIV Research Unit (PHRU) - Gauteng
- WITS RHI Shandukani Research Centre - Johannesburg
California
- Ronald Reagan UCLA Medical Center (inpatient hospital) - Los Angeles
Georgia
- Grady Health System - Ponce de Leon Center - Atlanta
Tennessee
- St Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-08-12 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
What NCT07055451 shows while recruiting
NCT07055451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (95% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which B/F/TAF is the first listed.
NCT07055451 lists 7 locations in 4 states (Other, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT07055451 about?
NCT07055451 is a clinical study titled "Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV". 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 im...
What is the current status of trial NCT07055451?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2025-08-12. Estimated completion is 2028-03.
What conditions does trial NCT07055451 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT07055451?
The interventions under investigation include: B/F/TAF (DRUG).
Who is sponsoring clinical trial NCT07055451?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07055451 being conducted?
This trial has 7 study locations across California, Georgia, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07055451's enrollment target sits among peer trials
16 66th of 71 higher than 6 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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