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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vesnarinone
Sponsored by
Otsuka America Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA School of Medicine
  • AIDS Research Consortium of Atlanta

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00002130
Brief Title
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
Official Title
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka America Pharmaceutical

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, Antiviral Agents, vesnarinone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vesnarinone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
900121973
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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