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.

This study has been completed.

First Received: November 2, 1999 Last Updated: November 11, 2005 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001100

Purpose

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
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.

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	130
Estimated Study Completion Date:	November 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	up to 1 Month
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001100

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Virus Diseases
Anti-Infective Agents
Communicable Diseases
Therapeutic Uses
Cytomegalovirus Infections
Ganciclovir

DNA Virus Infections
Infection
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009