Valganciclovir in Congenital CMV Infants

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Mar 6, 2002

Keywords

ClinConnect Summary

Recent trials have demonstrated that ganciclovir treatment of neonates with symptomatic congenital cytomegalovirus (CMV) disease involving the central nervous system results in improved hearing function (or maintenance of normal hearing function) and prevents hearing deterioration at 6 months. Furthermore, ganciclovir therapy may prevent hearing deterioration at 1 year. Ganciclovir recipients also have a more rapid resolution of their transaminase elevations and a greater degree of short term growth in weight and head circumference compared with untreated patients. Valganciclovir, the oral ...

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Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent from parent(s) or legal guardian(s).
• • Culture confirmation of cytomegalovirus (CMV) from urine or throat swab specimens.
• * Symptomatic congenital CMV disease, as manifest by one or more of the following:
• • Thrombocytopenia Petechiae Hepatomegaly Splenomegaly Intrauterine growth restriction Hepatitis (elevated transaminases and/or bilirubin) Central nervous system involvement of the CMV disease (such as microcephaly, radiographic abnormalities indicative of CMV CNS disease, abnormal CSF indices for age, chorioretinitis, hearing deficits as detected by brainstem evoked response, and/or positive CMV PCR from CSF)
• • Less than or equal to 30 days of age at study enrollment.
• • Weight at study enrollment greater than or equal to 1800 grams.
• • Gestational age greater than or equal to 32 weeks.
• Exclusion Criteria:
• • Imminent demise.
• • Patients receiving other antiviral agents or immune globulin.
• • Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis).
• • Creatinine clearance \< 10mL/min/1.73 square meters at time of study enrollment.
• • Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).