This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent
development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital
cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of
newborns to identify eligible subjects, and treatment of those newborns who have confirmed
CMV infection at birth but without outward manifestations of congenital CMV infection. 229
newborns with confirmed CMV infection but without baseline SNHL and who meet all
inclusion/exclusion criteria will be enrolled into the treatment phase. Study duration is 5
years. Primary objective of this study is to estimate the proportion of subjects with
asymptomatic congenital CMV infection who, following treatment with 4 months of oral
valganciclovir, develop SNHL by 6 months of life.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)