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The overall goal of this study is to determine the clinical benefit and safety of antiviral therapy for asymptomatic congenital cytomegalovirus (cCMV) infected hearing-impaired infants. We will conduct a multi-center double-blind randomized placebo-controlled trial to determine whether hearing-impaired infants with asymptomatic cCMV have better hearing and language outcomes if they receive valganciclovir antiviral treatment. We will also determine the safety of antiviral valganciclovir therapy for asymptomatic cCMV-infected hearing impaired infants. This study will be unique in that the cohort enrolled will only include hearing-impaired infants with asymptomatic cCMV. Aim 1: Test the hypothesis that asymptomatic CMV-infected hearing impaired infants treated with antiviral valganciclovir will have better hearing and language outcomes compared with untreated CMV-infected hearing impaired infants. Aim 2: Evaluate the safety of antiviral valganciclovir therapy for asymptomatic CMV-infected hearing impaired infants. Aim 3: Evaluate the pharmacokinetics (pK) of valganciclovir using pharmacometrics modeling to develop a population pK model.
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