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.

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.