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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001100 |
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 | Intervention | Phase |
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Cytomegalovirus Infections |
Drug: ganciclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 130 |
Estimated Study Completion Date: | November 2005 |
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 |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Infants may be eligible for this study if they:
Exclusion Criteria:
Infants will not be eligible for this study if they:
Study ID Numbers: | DMID ARB-AL-91-CMV, DAB-AL-558607 |
Study First Received: | November 2, 1999 |
Last Updated: | November 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00001100 |
Health Authority: | United States: Federal Government |
Virus Diseases Cytomegalovirus Infections Ganciclovir Congenital cytomegalovirus |
DNA Virus Infections Cytomegalic inclusion disease Cytomegalovirus Herpesviridae Infections |
Anti-Infective Agents Communicable Diseases Therapeutic Uses |
Infection Antiviral Agents Pharmacologic Actions |