Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002024
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1989
  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: Primary Purpose: Treatment
Official Title: Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

Resource links provided by NLM:


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

  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
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, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00002024     History of Changes
Other Study ID Numbers: 029B, ICM 1257A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on September 30, 2014