Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||December 1991|
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.
Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).
|Study Chair:||Richard J. Whitley|