Brief 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.
Brief Title
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
Conditions
Cytomegalovirus Retinitis
HIV Infections
Eligibility 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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Retinitis
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Immunocompromised Host
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
12 Years
Minimum Age
3 Months
NCT Id
NCT00002015
Org Class
Industry
Org Full Name
NIH AIDS Clinical Trials Information Service
Org Study Id
029G
Overall Status
Completed
Phases
Not Applicable
Official Title
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
Secondary Ids
Secondary Id
ICM 1788
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
12
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
George Ofori-Amanfo
Investigator Email
goforiam@montefiore.org
Investigator Phone