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.

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ganciclovir; Ganciclovir triphosphate

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.