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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002025
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002025


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

ClinicalTrials.gov Identifier: NCT00002025     History of Changes
Other Study ID Numbers: 029D
ICM 1691
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: September 1989

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Retinitis
Cytomegalovirus Infections
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Retinal Diseases
Eye Diseases
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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