Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
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 mean slope of total
hearing thresholds over the 20 months after randomization compared to untreated cCMV-infected
infants with isolated hearing loss.
Main Secondary Objectives:
1. To determine if valganciclovir treatment improves the following outcomes when compared
to the control group:
1. The slope of best ear hearing thresholds over the 20 months after randomization.
2. The MacArthur-Bates Communicative Development Inventory (CDI) percentile score for
words produced at 20 months of age.
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.
Phase:
Phase 2
Details
Lead Sponsor:
Albert Park
Collaborators:
Genentech, Inc. National Institute on Deafness and Other Communication Disorders (NIDCD)