Mycobacterium Avium Complex/mac |
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Clinical Trial: 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.
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Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| Mycobacterium avium-intracellulare Infection HIV Infections | Drug: Trifluridine |
MedlinePlus related topics: AIDS; Bacterial Infections
Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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.
Location Information
New York
New York Hosp - Cornell Med Ctr, New York, New York, 10021, United States
More Information
Record last reviewed: May 1991
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002037
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
Resources
- Simple Facts Sheets: MAC (AIDS Treatment Data Network)

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