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

This study has been completed.

Sponsored by: Hoffmann-La Roche
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention
Cytomegalovirus Infections
HIV Infections
 Drug: Ganciclovir

MedlinePlus related topics:  AIDS;   Cytomegalovirus Infections

Study Type: Interventional
Study Design: Treatment, Dose Comparison

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.


Location Information


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

More Information

Publications

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.

Study ID Numbers:  029B; ICM 1257A
Record last reviewed:  September 1989
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002024
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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