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An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

This study has been completed.

Sponsored by: Roche Global Development
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002015
  Purpose

To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Ganciclovir    Ganciclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Pharmacokinetics Study
Official Title:   An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   20

  Eligibility
Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical acyclovir.
  • Consult with the Syntex study monitor for the following:
  • Cytokines.
  • Soluble CD4.
  • Trichosanthin (Compound Q).
  • Imipenem-cilastatin.
  • Other investigational drugs.

Patients must have the following:

  • Congenital or acquired immune deficiency.
  • Eligibility to receive ganciclovir for the treatment of life- or sight-threatening Cytomegalovirus (CMV) disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria.
  • Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.

Concurrent Medication:

Excluded:

  • Other myelosuppressive drugs.
  • Antimetabolites.
  • Alkylating agents.
  • Nucleoside analogs (topical acyclovir is allowed).
  • Interferons.
  • Foscarnet.
  • Consult with the Syntex study monitor for the following:
  • Cytokines.
  • Soluble CD4.
  • Trichosanthin (Compound Q).
  • Imipenem-cilastatin.
  • Other investigational drugs.

Patients with the following are excluded:

  • Mild to moderate Cytomegalovirus (CMV) infection that does not meet the clinical severity criteria.
  • Absolute neutrophil count (ANC) < 500 cells/mm3 or a platelet count < 25000 platelets/mm3. Note:
  • Exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. In such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding.
  • Receiving excluded medications that it is not possible to discontinue.
  • Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
  • Demonstrated hypersensitivity to acyclovir or ganciclovir.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002015

Locations
United States, Alabama
Univ of Alabama at Birmingham    
      Birmingham, Alabama, United States, 35294
United States, California
Ctr for the Health Sciences / UCLA Med Ctr    
      Los Angeles, California, United States, 90095
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
Children's Hosp of Los Angeles    
      Los Angeles, California, United States, 90027
United States, Illinois
Univ of Chicago / Wylers    
      Chicago, Illinois, United States, 60637
United States, Nebraska
Univ of Nebraska Med Ctr    
      Omaha, Nebraska, United States, 681983280
United States, New York
Univ of Rochester Med Ctr    
      Rochester, New York, United States, 14642
United States, Texas
Baylor College of Medicine / Texas Children's Hosp    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
Roche Global Development
  More Information


Study ID Numbers:   029G, ICM 1788
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002015
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
Ganciclovir  
Cytomegalovirus Infections  
Acquired Immunodeficiency Syndrome  
Immunocompromised Host  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Eye Infections, Viral
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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