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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002015
• Other study ID #: 029G
• Secondary ID: ICM 1788
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Univ of Chicago / Wylers	Chicago	Illinois
United States	Baylor College of Medicine / Texas Children's Hosp	Houston	Texas
United States	Children's Hosp of Los Angeles	Los Angeles	California
United States	Ctr for the Health Sciences / UCLA Med Ctr	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Nebraska Med Ctr	Omaha	Nebraska
United States	Univ of Rochester Med Ctr	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roche Global Development

Country where clinical trial is conducted

United States,