A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
• •Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).
• •Concurrent Medication:
• •Excluded:
• •Antiretroviral agents, including ddI, ddC, AZT, and d4T.
• •Immunosuppressive agents.
• •Investigational HIV drugs/therapies including vaccines.
• •Interferon or other immunomodulating agents.
• •Corticosteroids (other than topical).
• •Hematopoietins.
• •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.
• •Patients with the following prior conditions are excluded:
• •Prior history of cardiac disease.
• •History of agranulocytosis or severe (grade 3 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function.
• •Prior Medication:
• •Excluded:
• •AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry.
• •Prior cytotoxic chemotherapy.
• •Acyclovir for herpes prophylaxis within 48 hours prior to study entry.
• •Prior Treatment:
• •Excluded within 30 days prior to study entry:
• •Erythropoietin, transfusion, or blood product use.
• •Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).