An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children
This study has been completed.
Sponsor:
Roche Global Development
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002015
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 3 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002015
Locations
| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Ctr for the Health Sciences / UCLA Med Ctr | |
| Los Angeles, California, United States, 90095 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| United States, Illinois | |
| Univ of Chicago / Wylers | |
| Chicago, Illinois, United States, 60637 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681983280 | |
| United States, New York | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| United States, Texas | |
| Baylor College of Medicine / Texas Children's Hosp | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Roche Global Development
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002015 History of Changes |
| Other Study ID Numbers: | 029G, ICM 1788 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Retinitis Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Immunocompromised Host |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013