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).