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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002015
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00002015     History of Changes
Other Study ID Numbers: 029G, ICM 1788
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
HIV Infections
Infection
Retinitis
Cytomegalovirus Infections
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retinal Diseases
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Ganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014