- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002025
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
June 23, 2005 updated by: Hoffmann-La Roche
To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy.
To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration.
To tabulate the patient's clinical response.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94303
- Roche Global Development - Palo Alto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
- Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
- Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
- Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
- Hypersensitivity to acyclovir or ganciclovir.
- Receiving antimetabolite treatment that cannot be discontinued.
Concurrent Medication:
Excluded:
- Antimetabolites.
- Alkylating agents.
- Nucleoside analogs (topical ophthalmics are permitted).
- Interferon.
- Foscarnet.
- Cytokines.
Patients with the following are excluded:
- Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
- Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
- Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
- Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
- Hypersensitivity to acyclovir or ganciclovir.
- Receiving antimetabolite treatment that cannot be discontinued.
Patients must qualify as follows:
- Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study.
- Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection.
- Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
September 1, 1989
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Eye Diseases
- Disease Attributes
- Retinal Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Eye Infections
- Eye Infections, Viral
- Infections
- Communicable Diseases
- Retinitis
- Cytomegalovirus Infections
- Cytomegalovirus Retinitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Ganciclovir
- Ganciclovir triphosphate
Other Study ID Numbers
- 029D
- ICM 1691
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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