HIV prevention drug tested in newborns: a step toward protecting infants
NCT ID NCT05406583
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Baylor College of Medicine/ Texas Children's Hospital NICHD CRS
Houston, Texas, 77030, United States
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Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, 10457, United States
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Chiang Mai University HIV Treatment
Chiang Mai, 50200, Thailand
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Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Rai, 57000, Thailand
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David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, 90095-1752, United States
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Emory University School of Medicine NICHD CRS
Atlanta, Georgia, 30322, United States
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FAMCRU
Cape Town, 7500, South Africa
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Rush University, Cook County Hospital Chicago NICHD CRS
Chicago, Illinois, 60612, United States
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Siriraj Hospital, Mahidol University NICHD CRS
Bangkok, 10700, Thailand
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Soweto
Johannesburg, Gauteng, 1864, South Africa
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-3678, United States
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USC - Maternal Child Adolescent/Adult Center
Los Angeles, California, 90033-1075, United States
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Umlazi
Durban, KwaZulu-Natal, 4013, South Africa
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University of Colorado Denver NICHD CRS
Aurora, Colorado, 80045, United States
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Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, 2001, South Africa