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Assessment of valganciclovir in neonates with CMV
This study is currently recruiting patients.
| Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
Primary:
Secondary:
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Cytomegalovirus Infections |
Drug: Ganciclovir Drug: Valganciclovir (Oral) |
Phase I Phase II |
MedlinePlus related topics: Cytomegalovirus Infections
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Uncontrolled, Factorial Assignment
Official Title: A Phase I/II Pharmacokinetic and Pharmacodynamic Evaluation of Oral Valganciclovir in Neonates with Symptomatic Congenital Cytomegalovirus (CMV) Infection Involving the Central Nervous System (CASG 109)
Expected Total Enrollment: 24
Study start: July 2002
Recent trials have demonstrated that ganciclovir treatment of neonates with symptomatic congenital CMV disease involving the CNS 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.
Ganciclovir therapy must be administered intravenously and often requires the establishment of a central line in these babies. Valganciclovir, the oral prodrug of ganciclovir, has been developed as a syrup formulation and presents the opportunity to treat longer without the requirement for a central line, but pharmacokinetic data are needed in infants first to assure the correct dose is being utilized.
This Phase I/II, multi-center, open-label trial will assess the safety/tolerability and pharmacokinetics (ganciclovir concentrations) following administration of oral valganciclovir to neonates with symptomatic congenital CMV disease. A total of 24 patients will be evaluated.
Two different dose determination strategies will be applied in this protocol. The first is an individual patient approach. The second is a group dose modification strategy.
The primary endpoint is pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup. The pharmacokinetics will be assessed by a population approach to PK data analysis. Secondary endpoints are: the pharmacokinetics of valganciclovir following administration of oral valganciclovir; the correlation of ganciclovir plasma concentrations following intravenous ganciclovir or oral valganciclovir syrup with CMV whole blood viral load; the incidence of emesis following oral valganciclovir administration (tolerability); safety as assessed by neutropenia incidence
Eligibility
Ages Eligible for Study: up to 1 Month, Genders Eligible for Study: Both
Criteria
INCLUSION CRITERIA:
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).
EXCLUSION CRITERIA:
Location
and Contact
Information
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