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Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Hoffmann-La Roche
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002024
  Purpose

To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.


Condition Intervention
Cytomegalovirus Infections
HIV Infections
Drug: Ganciclovir

Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical acyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
  • Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
  • Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
  • Neutropenia unless it is pre-existing.
  • Thrombocytopenia unless it is pre-existing.

Concurrent Medication:

Excluded:

  • Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs.

Patients with the following are excluded:

  • Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
  • Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
  • Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
  • Neutropenia unless it is pre-existing.
  • Thrombocytopenia unless it is pre-existing.

Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002024

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

Publications:
Study ID Numbers: 029B, ICM 1257A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002024     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Ganciclovir
Antiviral Agents
Cytomegalovirus
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Cytomegalic Inclusion Disease
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Ganciclovir
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009