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

Launched by OTSUKA AMERICA PHARMACEUTICAL · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
• • Acyclovir for acute treatment of herpes.
• • 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.