Valacyclovir in Neonatal Herpes Simplex Virus Disease
Status:
Recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
This is an open-label, single center, pharmacokinetic (PK) study to assess valacyclovir
pharmacokinetics and pharmacodynamics in neonates and compare to the pharmacokinetics and
pharmacodynamics of the standard of care treatment dose of intravenous acyclovir. 6 (up to 10
infants) with virologically confirmed neonatal herpes simplex virus (HSV) disease who meet
all inclusion/exclusion criteria will be enrolled in the study. Study duration is 5 years.
Primary objective is to define the pharmacokinetics of valacyclovir and assess its safety in
neonates 2-12 weeks of age who are ≥ 34 weeks gestation.