A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma

Inclusion Criteria

• Patients must have biopsy-proven AIDS-associated Kaposi's sarcoma.
• Evidence of HIV infection as manifested by a positive antibody test.

Exclusion Criteria

• Active drug or alcohol abuse.

Co-existing Condition:

Excluded are patients with:

• Active opportunistic infections requiring ongoing therapy.
• Excluded within 90 days of study entry:
• Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.
• Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
• Concurrent neoplasms other than basal cell carcinoma of the skin.
• Known hypersensitivity to polymycin B or neomycin.

Excluded are patients with:

• Active opportunistic infections requiring ongoing therapy.
• Excluded within 90 days of study entry:
• Must be off therapy for Pneumocystis carinii pneumonia (PCP) unless recovered.
• Clinically significant cardiac disease, including a history of myocardial infarction or arrhythmia.
• Concurrent neoplasms other than basal cell carcinoma of the skin.
• Known hypersensitivity to polymycin B or neomycin.

Prior Medication:

Excluded:

• Interferon.
• Zidovudine (AZT).
• Excluded within 30 days of study entry:
• Any biologic modifiers, corticosteroids, cytotoxic chemotherapeutic agents.
• Other drugs which can cause neutropenia or significant nephrotoxicity.
• Rifampin or rifampin derivatives, or systemic anti-infectives.
• Excluded within 90 days of study entry:
• Other antiviral agents.
• A history of Pneumocystis carinii pneumonia (PCP) completed treatment.

Prior Treatment:

Excluded within 30 days of study entry:

• Radiation therapy.