A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

The study will enroll 130 newborn infants 1 month of age or younger with CMV involving the CNS. Patients will be assigned randomly (like tossing a coin) to receive either DHPG or no study drug treatment. All babies in the study will receive standard of care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Follow-up evaluations, including hearing and eye exams and developmental assessments, will be done periodically until the child reaches 5 years of age. The degree of improved hearing among surviving patients will be a primary measure of drug effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Infants may be eligible for this study if they:
• • Were full term infants (at least 32 weeks gestation).
• • Are 1 month of age or younger (preferably less than 2 weeks).
• • Weighed at least 1,200 grams (2.5 lbs) at birth.
• • Have confirmed cytomegalovirus.
• • Have evidence of CMV infection of the CNS with or without evidence of other organ involvement.
• Exclusion Criteria:
• Infants will not be eligible for this study if they:
• • Have concurrent bacterial infection.
• • Have HIV infection.
• • Have mild symptoms or no symptoms of CMV infection at birth.
• • Have an abnormal brain development (hydranencephaly) or any devastating brain involvement.