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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 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.

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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

HIV-1-infection

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

FieldValue
Enrollment Target 16 participants
Start Date 2025-08-12
Est. Completion 2028-03
Phase Phase 1

Sponsor

Gilead Sciences

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07055451

The ClinicalTrials.gov registry entry for NCT07055451 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (95% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.