A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening.
• •Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix.
• •Concurrent Medication:
• •Excluded:
• •Antiretroviral agents, including ddI, ddC, and AZT.
• •Immunosuppressive agents.
• •Investigational HIV drugs/therapies including vaccines.
• •Interferon.
• •Steroids (other than topical).
• •Hematopoietins.
• •Megestrol acetate.
• •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) drug-induced neutropenia or documented abnormalities in granulocyte number or function.
• •Prior Medication:
• •Excluded:
• •AZT, ddI, and ddC within 14 days prior to study entry.
• •Prior cytotoxic chemotherapy.
• •Prior Treatment:
• •Excluded:
• •Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.
• •Active illicit drug abuse.