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

Sponsor
Otsuka America Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT00002130
Collaborator
(none)
2
Locations

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 0 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA School of Medicine Los Angeles California United States 900121973
    2 AIDS Research Consortium of Atlanta Atlanta Georgia United States 30308

    Sponsors and Collaborators

    • Otsuka America Pharmaceutical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002130
    Other Study ID Numbers:
    • 234C
    • 22-93-253
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Apr 1, 1996
    Keywords provided by , ,
    Acquired Immunodeficiency Syndrome
    Antiviral Agents
    vesnarinone
    Additional relevant MeSH terms:
    HIV Infections
    Vesnarinone

    Study Results

    No Results Posted as of Jun 24, 2005