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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Trifluridine

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.