Longitudinal CMV Study

CPIC 8604: A Longitudinal Study of the Durability of Valganciclovir Therapy on Long-Term Hearing and Neurodevelopmental Outcomes in Adolescents Treated During Infancy for Symptomatic Congenital Cytomegalovirus Diseases

Status: Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) and the most frequent viral cause of mental retardation. Approximately 10% of infants born with CMV infection are symptomatic at birth, and of these, one-third will develop SNHL and two-thirds will experience developmental delays. A previous clinical trial run by the Collaborative Antiviral Study Group (CASG study 112) studied babies with congenital CMV infection who received either 6 weeks or 6 months of oral valganciclovir therapy. The results from this study suggested that 6 months of oral valganciclovir improved measures of neurodevelopment and hearing compared to 6 weeks of the treatment. The purpose of the current study is to assess participants from the CASG trial as they turn 12 years old to determine if there are long-term benefits of antiviral therapy on hearing and neurodevelopmental outcomes. Further, the current study will examine the long-term safety profile of valganciclovir when administered during infancy by assessing reports of cancer diagnoses and signs of puberty in the CASG 112 participants. The goal of the study is to determine the long-term benefit and any potential toxicities of oral valganciclovir for the treatment of congenital CMV in infancy.