Purpose

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.


Condition Intervention
Cytomegalovirus Infections
Cytomegalovirus Retinitis
HIV Infections
 Drug: Ganciclovir

Genetics Home Reference related topics:   Retinal Disorders  

MedlinePlus related topics:   AIDS   Cytomegalovirus Infections  

ChemIDplus related topics:   Ganciclovir   Ganciclovir sodium  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
  Eligibility
Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002025

Locations
United States, California
Roche Global Development - Palo Alto    
      Palo Alto, California, United States, 94303

Sponsors and Collaborators
Hoffmann-La Roche
United States, California
Roche Global Development - Palo Alto    
      Palo Alto, California, United States, 94303
Hoffmann-La Roche
  More Information

Study ID Numbers:   029D, ICM 1691
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002025
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
AIDS-Related Opportunistic Infections  
Immune Tolerance  
Injections, Intravenous  
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
Bacterial Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Cytomegalovirus retinitis
Mycoses
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Cytomegalovirus Infections
DNA Virus Infections
Cytomegalic inclusion disease
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Eye Infections, Viral
Eye Diseases
Infection
Antiviral Agents
Pharmacologic Actions
Virus Diseases
Bacterial Infections and Mycoses
Therapeutic Uses
Lentivirus Infections

Source: National Library of Medicine (NLM) June 26, 2008

  
 
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