An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
NCT ID: NCT00002015
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Ganciclovir
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Months
12 Years
ALL
No
Sponsors
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Roche Global Development
OTHER
Locations
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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
Countries
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Other Identifiers
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ICM 1788
Identifier Type: -
Identifier Source: secondary_id
029G
Identifier Type: -
Identifier Source: org_study_id