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Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2000


I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.

Condition Intervention Phase
Cytomegalovirus Infections Drug: ganciclovir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 130
Study Start Date: December 1991
Detailed Description:

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.

Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.

Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).


Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Symptomatic cytomegalovirus (CMV) infection: Central nervous system disease, with or without other organ system involvement, e.g.: Microcephaly, i.e., less than 5% for age Radiologic changes indicating brain disease Cerebrospinal fluid exam abnormal for age Chorioretinitis Hearing defects
  • CMV confirmed by urine, throat, buffy coat, and/or conjunctiva culture
  • No hydroencephalopathy or other devastating brain involvement

--Prior/Concurrent Therapy--

  • No concurrent antiviral agent No concurrent immune globulin

--Patient Characteristics--

  • Age: Under 1 month (preferably under 2 weeks)
  • Life expectancy: No imminent demise
  • Renal: Creatinine no greater than 1.5 mg/dL
  • Other: Birth weight at least 1200 g Gestational age at least 32 weeks No HIV infection No concurrent bacterial infection Eligible if resolved following 2-week treatment and CMV symptoms persist
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Please refer to this study by its identifier: NCT00004278

Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Richard J. Whitley
  More Information Identifier: NCT00004278     History of Changes
Other Study ID Numbers: 199/11689
Study First Received: October 18, 1999
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
congenital cytomegalovirus infection
cytomegalovirus infection
herpesvirus infection
immunologic disorders and infectious disorders
neonatal disorders
rare disease
viral infection

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017