An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
2 other identifiers
interventional
20
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Ctr for the Health Sciences / UCLA Med Ctr
Los Angeles, California, 90095, United States
Univ of Chicago / Wylers
Chicago, Illinois, 60637, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681983280, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Baylor College of Medicine / Texas Children's Hosp
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04