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

Amgen

Status: Completed

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Treatments: Drug: Trifluridine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002037

062B

IFNG-8701

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.