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

• Patient must have a histologically confirmed diagnosis of Kaposi's sarcoma.
• Positive antibody to HIV confirmed by ELISA or Western blot on the same serum.

Exclusion Criteria

• Active drug or alcohol abuse.

Co-existing Condition:

Patients with the following complications are excluded:

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

Patients with the following complications are excluded:

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

Prior Medication:

Excluded:

• Any prior zidovudine (AZT) or interferon alpha protocol participation.
• Excluded within 30 days of study entry:
• Immunomodulating agents.
• Other drugs that can cause neutropenia or significant nephrotoxicity, or systemic anti-infectives.
• Excluded within 90 days of study entry:
• Antiretroviral agents.
• Treatment of Pneumocystis carinii pneumonia (PCP).

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