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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001100
First Posted: August 31, 2001
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00001100     History of Changes
Other Study ID Numbers: DMID ARB-AL-91-CMV
DAB-AL-558607
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: August 27, 2010
Last Verified: November 2005

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action