Valganciclovir in Congenital CMV Infants

Completed · Phase 1/Phase 2

Conditions studied: Cytomegalovirus Infections

In brief

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.

Key facts

Study ID

NCT00031434

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Starts

2002-07-01

Expected to finish

2007-07-01

Last updated by the study team

2011-02-07

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Arkansas — Little Rock, Arkansas, United States
• University of Southern California — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Stanford University — Stanford, California, United States
• University of Florida — Jacksonville, Florida, United States
• Stroger Cook Hospital — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Creighton University — Omaha, Nebraska, United States
• Schneider Children's Hospital — Manhasset, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• The University of Texas Medical Branch — Galveston, Texas, United States
• The University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.