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New HIV drug cocktail tested in newborns to block transmission

NCT ID NCT07055451

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This early-stage study is testing the safety and how the body handles a new combination HIV drug (B/F/TAF) in full-term newborns who were exposed to HIV at birth. The goal is to see if this drug can be used to prevent the babies from getting infected. The study involves 16 infants and focuses on side effects and drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF)
What this could lead to
If successful, this could provide a safe and effective way to prevent HIV infection in newborns exposed to the virus.
What could go wrong
This is a very early Phase 1b study with only 16 participants, so results may not apply to all newborns. The drug's safety and effectiveness in this age group are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 120 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, 4013, South Africa

  • Family Centre for Research with Ubuntu (FAMCRU)

    Cape Town, 7505, South Africa

  • Grady Health System - Ponce de Leon Center

    Atlanta, Georgia, 30308, United States

  • Perinatal HIV Research Unit (PHRU)

    Gauteng, 1864, South Africa

  • Ronald Reagan UCLA Medical Center (inpatient hospital)

    Los Angeles, California, 90095, United States

  • St Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • WITS RHI Shandukani Research Centre

    Johannesburg, 2001, South Africa

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