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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002024 on ClinicalTrials.gov Archive Site
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Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

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.

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Interventional
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Primary Purpose: Treatment
  • Cytomegalovirus Infections
  • HIV Infections
Drug: Ganciclovir
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Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002024
029B, ICM 1257A
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
September 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP