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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
Official Title ^ICMJE	An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Pharmacokinetics Study
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Ganciclovir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	3 Months to 12 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002015
Responsible Party
Study ID Numbers ^ICMJE	029G, ICM 1788
Study Sponsor ^ICMJE	Roche Global Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP