Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

Inclusion Criteria

Concurrent Medication:

Allowed:

• Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks.
• AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study.

Concurrent Treatment:

Allowed:

• Blood transfusions.

Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Other antiretroviral agents.
• Immunomodulators.
• Corticosteroids.
• Cytotoxic chemotherapy.
• Aspirin.
• H2 blockers.
• Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a.
• Other experimental medications.

Concurrent Treatment:

Excluded:

• Radiation therapy.

Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study.

Prior Medication:

Excluded:

• Interferon therapy.
• Excluded within 30 days of study entry:
• Immunomodulators.
• Corticosteroids.
• Cytotoxic chemotherapeutic agents.
• Excluded within 14 days of study entry:
• Zidovudine (AZT).

Prior Treatment:

Excluded within 30 days of study entry:

• Blood transfusions.
• Radiation therapy.

Patients may not have any of the following diseases or symptoms:

• Active opportunistic infection associated with AIDS.
• Significant neurologic disease associated with AIDS, as manifested by motor abnormalities including impaired rapid eye movement or ataxia, motor weakness in the lower extremities, sensory deficit consistent with a peripheral neuropathy, bladder or bowel incontinence.
• Internal organ involvement with Kaposi's sarcoma, i.e., nonnodal visceral Kaposi's sarcoma, excluding minimal gastrointestinal disease of less than 5 lesions.
• Tumor-associated edema.
• Current neoplasm other than Kaposi's sarcoma.
• Significant cardiac disease, including a recent history of myocardial infarction or significant current cardiac arrhythmias.

Active drug or alcohol abuse.