A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
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To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.
Condition or disease
Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
Acyclovir for acute treatment of herpes.
Antiretroviral agents, including ddI, ddC, AZT, and d4T.
Investigational HIV drugs/therapies including vaccines.
Interferon or other immunomodulating agents.
Corticosteroids (other than topical).
Agents known to cause neutropenia.
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.
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.