Testing a new antiviral drug to prevent herpes in newborns

Valacyclovir Phase I Trial

NIH-funded research University of Alabama at Birmingham · NIH-10915387

This study is looking at how safe and effective the antiviral medicine Valacyclovir is for newborns at risk of getting herpes from their mothers during birth, with the goal of keeping these little ones healthy and safe.

Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionUniversity of Alabama at Birmingham NIH-funded
Lab location1 site (Birmingham, United States)
Project IDNIH-10915387 on NIH RePORTER

What this research studies

This research investigates the safety and effectiveness of Valacyclovir, an antiviral medication, in infants who are at risk of acquiring neonatal herpes simplex virus (HSV) disease. The study aims to identify mothers who may be shedding the virus during delivery through a rapid test, allowing targeted treatment for their newborns. By preventing the onset of HSV disease, which can lead to severe complications or death in infants, this research seeks to improve outcomes for vulnerable newborns. The approach includes multiple doses of the medication and monitoring its pharmacokinetics in the infant population.

Who could benefit from this research

Good fit: Ideal candidates for this research include infants at risk of neonatal herpes simplex virus disease, particularly those born to mothers who may be shedding the virus.

Not a fit: Patients who are not newborns or those not at risk of neonatal herpes will not benefit from this research.

Why it matters

Potential benefit: If successful, this research could significantly reduce the incidence of neonatal herpes and its associated complications in newborns.

How similar studies have performed: Previous research has shown promising results with antiviral therapies in preventing neonatal herpes, making this approach a continuation of established methods.

Where this research is happening

Birmingham, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Acquired Immune Deficiency SyndromeAcquired Immunodeficiency Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.