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).

Condition	Treatment or Intervention	Phase
Cytomegalovirus Infections	Drug: ganciclovir	Phase III

Further Study Details: 

Expected Total Enrollment:  130

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.

Ages Eligible for Study:  up to  1 Month,  Genders Eligible for Study:  Both

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.

Alabama
      NIAID/DMID/CASG Central Unit, Birmingham,  Alabama,  35294,  United States

Study ID Numbers:  DMID ARB-AL-91-CMV; DAB-AL-558607
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001100
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08