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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002037
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1991

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002037 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
Drug: Trifluridine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002037
062B, IFNG-8701
Not Provided
Not Provided
Amgen
Not Provided
Not Provided
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