Congenital Cytomegalovirus clinical trials at UCSF
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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. Primary Objective: To determine if treatment of cCMV-infected hearing impaired infants with isolated hearing loss with the antiviral drug valganciclovir reduces the maximum worsening in left or right ear hearing 8 months after randomization compared to untreated cCMV-infected hearing impaired infants. Main Secondary Objectives: 1. To determine if valganciclovir treatment improves the following outcomes when compared to the control group: 1. The risk of a clinically significant worsening of hearing defined by occurrence of cochlear implantation due to progressive hearing loss or a ≥ 10 dB (decibel) increase in the minimum response level (MRL) at two or more audiometric test frequencies (from among 1 kHz, 2 kHz, and 4kHz) in either the left or right ear or a ≥ 15 dB increase at any of these frequencies in either the left or right ear between baseline and 8 months post-randomization. 2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for words produced at 22 months of age. 3. The change in the average MRL across the 2 and 4 kHz frequencies from baseline to 8 months post-randomization in the best-ear. 2. To evaluate safety measures based on all grade 3 or greater new adverse events designated by the NIAID Division of AIDS (DAIDS) toxicity tables.
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