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Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002037
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
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.
Not Provided
Interventional
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Masking: None (Open Label)
Primary Purpose: Treatment
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
Drug: Trifluridine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
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Inclusion Criteria

Patients must have:

  • Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
  • Life expectancy of at least 3 months.
  • Baseline chest X-ray and EKG (electrocardiogram).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Known hypersensitivity to interferons or other exogenous lymphokine.
  • History of cardiac abnormality or disease.
  • History of hypertension.

Patients with the following are excluded:

  • Known hypersensitivity to interferons or other exogenous lymphokine.
  • History of cardiac abnormality or disease.
  • History of hypertension.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Corticosteroids.
  • Anti-inflammatory medication (except aspirin).
  • Changes in the dose of anti-mycobacterial drugs.
  • Immune agents.

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Radiotherapy.

Risk Behavior:

Excluded:

  • Intravenous drug abuse.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002037
062B
IFNG-8701
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Amgen
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NIH AIDS Clinical Trials Information Service
May 1991

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