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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ganciclovir; Ganciclovir triphosphate

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