Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
Cytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The
purpose of this study is to compare a 6-week course to a 6-month course of the drug
valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment.
Participants will include 104 infants (30 days old or younger) born with CMV disease. All
infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period,
subjects will be assigned by chance to receive either valganciclovir or placebo (inactive
substance) to complete the 6 months of antiviral treatment. Patients will be followed for the
study related evaluations of safety, changes to hearing, and developmental milestones for up
to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus,
participants may be involved in study related procedures for approximately 5 years.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)