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Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

This study has been completed.
Study NCT00002025.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Official Title  Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cytomegalovirus Infections
Cytomegalovirus Retinitis
HIV Infections
Intervention  Drug: Ganciclovir
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

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.
Gender Both
Ages 3 Months and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002025
Organization ID 029D
Secondary IDs †† ICM 1691
Study Sponsor  Hoffmann-La Roche
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date September 1989
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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