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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka America Pharmaceutical
• Treatments: Vesnarinone

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.