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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

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.

Interventions

  • Drug: Vesnarinone

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Otsuka America Pharmaceutical

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