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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 3

Conditions: Cytomegalovirus Infections

Treatments: Drug: ganciclovir

Study type: Interventional

Funder types: NIH

Identifiers

NCT00004278

NIAID-558607

199/11689

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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