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.

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.

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.