A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons

Exclusion Criteria

• •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).
• •Megestrol acetate.
• •Agents known to cause neutropenia.
• •Ganciclovir.
• •Cytotoxic chemotherapy.
• •Concurrent Treatment:
• •Excluded:
• •Radiation therapy.
• •Patients with the following prior conditions are excluded:
• •Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B).
• •Missed more than one clinic visit on the Phase I protocol.
• •Prior Medication:
• •Excluded:
• •Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.
• •Patients meet the following criteria:
• •Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B.
• •Active illicit drug abuse.