Neonatal Phase 1 Valacyclovir Study

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jul 19, 2022

Keywords

ClinConnect Summary

The Neonatal Phase 1 Valacyclovir Study is a clinical trial designed to find the right dose of a medication called valacyclovir for newborns who might be at risk of getting a herpes infection. The goal is to see how well this oral medication can provide a similar level of protection as a commonly used injectable drug called acyclovir. The study will involve two groups of infants. The first group will receive an initial dose of valacyclovir, and the researchers will closely monitor how the medication works in their bodies. If the results are positive, a second group will then receive an adjusted dose based on the findings from the first group.

To participate in this trial, infants must be between 1 and 2 days old, weigh at least 2,000 grams, and be born to mothers with a history of genital herpes who have received specific antiviral treatments just before delivery. It's important to note that infants with signs of herpes infection or other serious health issues will not be eligible. Families who choose to participate can expect a thorough evaluation and ongoing support throughout the study to ensure the safety and well-being of their babies.

Gender

ALL

Eligibility criteria

• 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