This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Congenital cytomegalovirus (CMV) infection is the most common congenital infection in humans and leaves approximately 9,000 children each year with permanent neurologic sequelae. This multicenter clinical trial is the first attempt to scientifically study an antiviral therapeutic intervention for congenital CMV disease. Phase I/II trials are completed and a Phase III, multicenter controlled trial was begun in 1991 to determine if treatment of neonates, with virologically confirmed congenital CMV disease and evidence of central nervous system involvement, with ganciclovir, administered at a dose of 6 mg/kg intravenously every 12 hours for 6 weeks, will accelerate resolution of acute disease, produce adverse clinical or laboratory toxicity which may negate clinical benefits of treatment, or beneficially influence growth and development, decrease auditory and visual impairment, and improve intellectual outcome. Recently, on December 9, 1999, enrollment of new subjects was halted, resulting in a total of 16 subjects enrolled, here in Houston, and 100 nationally. Preliminary analysis reveals ganciclovir treatment protects against hearing deterioration at one year of age (p = 0.0037). Treated subjects also had greater mean head circumference at 6 weeks of age (p = 0.022) than untreated subjects. However, treated subjects also had significantly more instances of reversible neutropenia (p = 0.0001) than untreated subjects. Neonatal treatment with intravenous ganciclovir may provide clinical benefit during the first year, but is associated with frequent but manageable early side effects. Continued follow-up is needed to see if the benefit is long-lasting or if long-term toxicities occur.
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