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

Condition(s) targeted: Cytomegalovirus Infections

Intervention: ganciclovir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Richard J. Whitley, Study Chair

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.

Study design: Interventional, Treatment, Randomized

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).

Maximum age: 1 Month. Gender(s): Both.

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

Starting date: December 1991
Last updated: June 23, 2005