The purpose of this study is to evaluate how ganciclovir is metabolized when administered
intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by
mouth to newborns and young infants with symptoms of congenital (present at birth)
cytomegalovirus (CMV) disease. The study also seeks to identify a dose of valganciclovir that
provides a comparable blood concentration to ganciclovir present in the blood of newborns
with symptomatic congenital CMV disease. All study participants will receive 6 weeks of
antiviral therapy (defined as ganciclovir and/or valganciclovir). Infants from 0 to 30 days
old will participate in the study for 2 years.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)