Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
Sarcoma, Kaposi, HIV Infections
About this trial
This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Interferon Alfa-2a, Drug Evaluation, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine
Eligibility Criteria
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.
Sites / Locations
- Univ. of Miami AIDS CRS
- Johns Hopkins Adult AIDS CRS
- Beth Israel Deaconess - East Campus A0102 CRS
- Washington U CRS
- Beth Israel Med. Ctr. (Mt. Sinai)
- Univ. of Rochester ACTG CRS
- Case CRS
- The Ohio State Univ. AIDS CRS
- Pitt CRS