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OpenTrials
Completed

NCT Number: NCT00002015

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

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.

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Key information

Conditions

Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Amino Acid Metabolism, Inborn Errors Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytomegalovirus Infections DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Genetic Diseases, Inborn Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases RNA Virus Infections Retinal Diseases Retinitis Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

3 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ganciclovir

Drug

Sponsors and collaborators

Lead sponsor

Roche Global Development

Other

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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