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

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002015

Run by

Roche Global Development

People needed

20

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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