HIV prevention drug tested in newborns: a step toward protecting infants

NCT ID NCT05406583

Completed Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

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

Summary

This study tested the safety and how the body processes the HIV drug dolutegravir in newborns whose mothers have HIV. A total of 48 mother-infant pairs from four countries participated. Infants received either a liquid or tablet form of the drug during their first weeks of life, and researchers monitored for side effects and drug levels in the blood. The goal was to find a safe dose that could help prevent HIV transmission to the baby.

What this could mean

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

Active substance: Dolutegravir (DTG) liquid suspension or dispersible tablets
What this could lead to: If successful, this could help establish a safe and effective dose of dolutegravir to prevent HIV infection in newborns exposed to the virus.
What could go wrong: This is an early phase 1 study focused on safety and dosing, not on proving the drug prevents HIV. The results may not apply to all newborns or settings.

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.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

Baylor College of Medicine/ Texas Children's Hospital NICHD CRS

Houston, Texas, 77030, United States
Bronx-Lebanon Hospital Center NICHD CRS

The Bronx, New York, 10457, United States
Chiang Mai University HIV Treatment

Chiang Mai, 50200, Thailand
Chiangrai Prachanukroh Hospital NICHD CRS

Chiang Rai, 57000, Thailand
David Geffen School of Medicine at UCLA NICHD CRS

Los Angeles, California, 90095-1752, United States
Emory University School of Medicine NICHD CRS

Atlanta, Georgia, 30322, United States
FAMCRU

Cape Town, 7500, South Africa
Rush University, Cook County Hospital Chicago NICHD CRS

Chicago, Illinois, 60612, United States
Siriraj Hospital, Mahidol University NICHD CRS

Bangkok, 10700, Thailand
Soweto

Johannesburg, Gauteng, 1864, South Africa
St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States
USC - Maternal Child Adolescent/Adult Center

Los Angeles, California, 90033-1075, United States
Umlazi

Durban, KwaZulu-Natal, 4013, South Africa
University of Colorado Denver NICHD CRS

Aurora, Colorado, 80045, United States
Wits RHI Shandukani Research Centre CRS

Johannesburg, Gauteng, 2001, South Africa

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