drugset / Trial / NCT00031434
Valganciclovir in Congenital CMV Infants
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate how ganciclovir is metabolized when administered intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by mouth to newborns and young infants with symptoms of congenital (present at birth) cytomegalovirus (CMV) disease. The study also seeks to identify a dose of valganciclovir that provides a comparable blood concentration to ganciclovir present in the blood of newborns with symptomatic congenital CMV disease. All study participants will receive 6 weeks of antiviral therapy (defined as ganciclovir and/or valganciclovir). Infants from 0 to 30 days old will participate in the study for 2 years.
Timeline
- Start
- 2002-07
- Primary completion
- 2007-07
- Completion
- 2007-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganciclovir | Small molecule | 6 mg/kg | Intravenous |
| Subject | Valganciclovir | Small molecule | 14 mg/kg | Oral |