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:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001100
First received: November 2, 1999
Last updated: August 26, 2010
Last verified: November 2005

November 2, 1999
August 26, 2010
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Complete list of historical versions of study NCT00001100 on ClinicalTrials.gov Archive Site
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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.
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.

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cytomegalovirus Infections
Drug: ganciclovir
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Oliver SE, Cloud GA, Sánchez PJ, Demmler GJ, Dankner W, Shelton M, Jacobs RF, Vaudry W, Pass RF, Soong SJ, Whitley RJ, Kimberlin DW; National Institute of Allergy, Infectious Diseases Collaborative Antiviral Study Group. Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system. J Clin Virol. 2009 Dec;46 Suppl 4:S22-6. Epub 2009 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
November 2005
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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.
Both
up to 1 Month
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001100
DMID ARB-AL-91-CMV, DAB-AL-558607
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP