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

Cytomegalovirus Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004278
• Other study ID #: 199/11689
• Secondary ID: NIAID-558607
• Status: Completed
• Phase: Phase 3
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: December 1991

Study information

• Verified date: July 2000
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

PROTOCOL ENTRY CRITERIA:

--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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infection

Intervention

Drug:
• ganciclovir

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	National Institute of Allergy and Infectious Diseases (NIAID)