A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma

Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria. Acyclovir as acute treatment for herpes outbreaks. Concurrent Treatment: Allowed: Limited electron-beam radiation therapy to non-marker lesions for treatment of Kaposi's sarcoma. Patients must have: Documented HIV infection. Kaposi's sarcoma. No current constitutional signs of HIV disease or AIDS-defining conditions other than Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in situ carcinoma of the cervix. Current significant cardiac disease or anomaly (including prolonged QTC on EKG). Abnormal cardio-thoracic ratio on chest x-ray. Concurrent Medication: Excluded: Antiretroviral agents, including ddI, ddC, AZT, and d4T. Immunosuppressive agents. Investigational HIV drugs/therapies including vaccines (except those on treatment IND for approved indications). Other anti-Kaposi's sarcoma/HIV drugs. Corticosteroids (other than topical). Biologic response modifiers. Megestrol acetate. Agents known to cause neutropenia. Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. Cytotoxic chemotherapy. Concurrent Treatment: Excluded: Radiation therapy including electron beam irradiation (other than limited electron-beam radiation to non-marker lesions for treatment of Kaposi's sarcoma). Patients with the following prior conditions are excluded: Prior history of significant cardiac disease or anomaly. History of agranulocytosis or severe grade 3 drug-induced neutropenia or documented abnormalities in granulocyte function. Prior Medication: Excluded: AZT within 14 days prior to study entry. Acyclovir as prophylaxis for herpes within 48 hours prior to study entry. Excluded within 30 days prior to study entry: Interferon. Biologic response modifiers. Cytotoxic chemotherapy. Prior Treatment: Excluded within 30 days prior to study entry: Blood or cellular blood product. Active illicit drug abuse (specifically cocaine, amyl nitrate, heroin, or other cardioactive agents).