Valacyclovir PK Study

CPIC 8602: A Phase I Adaptive, Multiple Dose Pharmacokinetic and Safety Assessment of Valacyclovir in Infants At Risk of Acquiring Neonatal Herpes Simplex Virus Disease (DMID 20-0033)

Status: Not Yet Recruiting

The purpose of this study is to evaluate at-risk babies to determine the appropriate dose of oral valacyclovir comparable to the intravenous (IV) acyclovir doses typically used to treat babies with neonatal Herpes Simplex Virus (HSV) disease. IV acyclovir is best for the treatment of babies who already have HSV disease, but it is not ideal to prevent HSV disease because there are risks associated with IV use in babies. Valacyclovir is metabolized to become acyclovir, and although it has been studied in babies as young as one month old, there are no dosing recommendations for those less than three months old. This study focuses on at-risk babies whose mothers have a history of genital HSV infection and have been taking oral acyclovir or valacyclovir for several weeks before delivery. By studying the blood concentration, metabolism, clearance and safety profile of valacyclovir in infants less than one month old, we will determine the best dose of valacyclovir to prevent HSV infection when babies are exposed to it at birth. We will also inform larger studies using valacyclovir to treat neonatal HSV disease.