Cmv Congenital clinical trials at UCSF
1 in progress, 0 open to new patients
Sorry, accepting new patients by invitation only
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.
San Francisco, California and other locations