The purpose of this study is to evaluate the benefits and safety of the antiviral drug
ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with
cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body,
resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain
damage in a large percentage of surviving babies. Children in this study have a CMV
infection of the central nervous system (CNS).
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.
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
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