New study tests oral antiviral for newborns exposed to herpes
NCT ID NCT05468619
First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This Phase 1 study tested different doses of the oral antiviral drug valacyclovir in 17 newborns whose mothers had genital herpes. The goal was to find a dose that gives similar drug levels in the blood as the standard IV treatment. Researchers measured how the drug was processed and checked for side effects. The study is complete and helps guide future dosing for infants at risk of neonatal herpes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Valacyclovir (an antiviral drug given by mouth)
- What this could lead to
- If successful, this could help doctors give oral valacyclovir to newborns at risk of herpes, avoiding the need for IV treatment.
- What could go wrong
- This is a very early, small Phase 1 study with only 17 infants. It focuses on dosing and safety, not on curing or preventing disease. Results may not apply to all newborns.
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
-
17 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Jul 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 2 days
- Sex
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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 Hide 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.
Inclusion Criteria: 1. Signed informed consent from parent(s) or legal guardian(s) 2. Maternal history of genital HSV infection 3. Maternal receipt of oral acyclovir, valacyclovir, or famciclovir suppressive therapy for \>/= 7 days prior to delivery 4. Gestational age \>/= 38 weeks at birth 5. \</= 2 days of age at study enrollment\* 6. Weight at study enrollment \>/= 2,000 grams * For purposes of this study, the calendar day of birth is Day of Life 0 Exclusion Criteria: 1. Evidence of neonatal HSV infection 2. Evidence of sepsis 3. Known renal anomalies or dysfunction 4. Maternal genital lesions suspicious for HSV at the time of delivery 5. Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry) 6. Current receipt in the neonate of acyclovir, ganciclovir, famciclovir, or any investigational drugs
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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
Locations
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Atrium Health ID Consultants & Infusion Care Specialists
Charlotte, North Carolina, 28207, United States
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Children's Nebraska
Omaha, Nebraska, 68114-4108, United States
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Children's of Alabama Child Health Research Unit (CHRU)
Birmingham, Alabama, 35233-0011, United States
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Emory University School of Medicine
Atlanta, Georgia, 30322-1014, United States
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M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205-2664, United States
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SUNY Upstate Medical University Hospital - Pediatrics
Syracuse, New York, 13210-2342, United States
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Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease
Queens, New York, 11040, United States
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University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
Louisville, Kentucky, 40202, United States
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University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001, United States
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Washington University in St. Louis
St Louis, Missouri, 63110-1010, United States
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