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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety