Overview

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