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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002130
• Other study ID #: 234C
• Secondary ID: 22-93-253
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Vesnarinone

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	UCLA School of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka America Pharmaceutical

Country where clinical trial is conducted

United States,