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.

Cytomegalovirus Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001100
• Other study ID #: DMID ARB-AL-91-CMV
• Secondary ID: DAB-AL-558607
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: August 26, 2010
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infection

Intervention

Drug:
• ganciclovir

Locations

Country	Name	City	State
United States	NIAID/DMID/CASG Central Unit	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,