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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002130
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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
HIV Infections Drug: Vesnarinone Not Applicable

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 Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
  • Acyclovir for acute treatment of herpes.

Exclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002130

United States, California
UCLA School of Medicine
Los Angeles, California, United States, 900121973
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Otsuka America Pharmaceutical Identifier: NCT00002130     History of Changes
Other Study ID Numbers: 234C
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents