New HIV drug cocktail tested in newborns to block transmission

NCT ID NCT07055451

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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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