# Longitudinal CMV

> **NIH NIH U54** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2020 · $375,626

## Abstract

This project, 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 (CMV) Diseases, will be led by David W. Kimberlin, MD. It uses a randomized cohort from an
earlier study of the treatment of infants with symptomatic congenital CMV disease to ascertain whether the
treatment benefits on hearing and developmental outcomes seen to 2 years of age persist over the ensuing
decade. That study, known as the CASG 112 trial, was conducted by the Collaborative Antiviral Study Group
and enrolled 109 subjects between 2008 and 2011. It documented that a 6 month duration of treatment of
symptomatic congenital CMV provided superior hearing and developmental outcomes compared with 6 weeks
of antiviral treatment, and that these benefits persisted to 2 years of age. What is not known, though, is
whether these benefits persist longer than this, and whether there are any longer-term toxicities from
valganciclovir therapy provided very early in life.
Subjects previously enrolled in the CASG 112 study are approaching their 12th birthday. We will bring them
back when they are 12 years of age for hearing and developmental assessments. Returning subjects also will
have a pubertal assessment as a marker for potential gonadotoxicity from the earlier valganciclovir therapy,
and for inquiry about development of any cancers.
The results of this study will be important. If these benefits on hearing and development are durable, it
suggests that treatment does not need to be longer than 6 months duration. On the other hand, if the benefits
of 6 months of treatment are not durable (that is, if they wane over time), this is of equal value because it
illumines the next study that needs to be conducted to assesses treatment of perhaps 12 months (or even
longer), with or without the addition of a second antiviral drug such as letermovir. Also, if longer-term toxicities
from the earlier valganciclovir therapy are identified, this will have a direct impact on the clinical treatment of
patients with symptomatic congenital CMV disease. Most importantly, knowledge will be gained from this
longitudinal study of long-term hearing and developmental outcomes following what is now the standard
duration of treatment (6 months) that will benefit children who have received this course of therapy.

## Key facts

- **NIH application ID:** 10001430
- **Project number:** 5U54AI150225-02
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** David W. Kimberlin
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $375,626
- **Award type:** 5
- **Project period:** 2019-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10001430

## Citation

> US National Institutes of Health, RePORTER application 10001430, Longitudinal CMV (5U54AI150225-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10001430. Licensed CC0.

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