24
Participants
Start Date
July 31, 2002
Primary Completion Date
July 31, 2007
Study Completion Date
July 31, 2007
Valganciclovir
Valganciclovir is a mono-valyl ester pro-drug of ganciclovir, which is rapidly converted to ganciclovir on absorption. Valganciclovir oral syrup formulation for administration will be provided as a 15g powder blend containing 3g valganciclovir base, for constitution in 120 mL amber glass bottles. The beginning oral valganciclovir dose under investigation is 14 mg/kg. The dose of oral valganciclovir syrup will be adjusted for the baby's weight and renal function. Weights upon which dosage will be adjustments will be made will be obtained on study days 1, 7, 14, 21, 28, and 35.
Ganciclovir
Ganciclovir for intravenous infusion will be provided as sterile, lyophilized powder in sealed vials containing 500 mg ganciclovir for re-constitution. The dose of intravenous ganciclovir is 6 mg/kg. Intravenous ganciclovir will be adjusted for the baby's weight and renal function. Weights upon which dosage adjustments will be made will be obtained on study days 1, 7, 14, 21, 28, and 35. Each dose of intravenous ganciclovir should be given over 1 hour using an intravenous pump.
Schneider Children's Hospital, Manhasset
SUNY Upstate Medical University, Syracuse
Johns Hopkins University, Baltimore
Medical University of South Carolina, Charleston
University of Florida, Jacksonville
University of Alabama at Birmingham, Birmingham
Ohio State University, Columbus
Stroger Cook Hospital, Chicago
Washington University in St. Louis, St Louis
Tulane University, New Orleans
Cook Children's Medical Center, Fort Worth
The University of Texas Medical Branch, Galveston
The University of Texas Health Science Center, San Antonio
University of Southern California, Los Angeles
Children's Hospital of Orange County, Orange
Stanford University, Stanford
University of Arkansas, Little Rock
University of Louisville, Louisville
Creighton University, Omaha
MetroHealth Medical Center, Cleveland
The University of Texas Southwestern Medical Center, Dallas
National Institute of Allergy and Infectious Diseases (NIAID)
NIH