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A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

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ClinicalTrials.gov Identifier: NCT00002129
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 safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Vesnarinone Phase 1

Detailed Description:
Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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

Inclusion Criteria

Concurrent Medication:


  • Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and herpes simplex.

Patients must have:

  • Asymptomatic HIV infection.
  • CD4 count > 300 cells/mm3.
  • No prior AIDS-defining illness or current constitutional symptoms of HIV disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening.
  • Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix.

Concurrent Medication:


  • Antiretroviral agents, including ddI, ddC, and AZT.
  • Immunosuppressive agents.
  • Investigational HIV drugs/therapies including vaccines.
  • Interferon.
  • Steroids (other than topical).
  • Hematopoietins.
  • Megestrol acetate.
  • Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
  • Cytotoxic chemotherapy.

Concurrent Treatment:


  • Radiation therapy.

Patients with the following prior conditions are excluded:

  • Prior history of cardiac disease.
  • History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function.

Prior Medication:


  • AZT, ddI, and ddC within 14 days prior to study entry.
  • Prior cytotoxic chemotherapy.

Prior Treatment:


  • Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.

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 ClinicalTrials.gov identifier (NCT number): NCT00002129

United States, California
UCLA School of Medicine
Los Angeles, California, United States, 900121973
Sponsors and Collaborators
Otsuka America Pharmaceutical

Mitsuyasu R, Bort L, Miles SA, Hardy WD, Petit RG. Preliminary results of a phase I study of vesnarinone (OPC-8212) in HIV-infected persons with CD4 > 300 cells/MM3. Int Conf AIDS. 1994 Aug 7-12;10(1):8 (abstract no 005B)

ClinicalTrials.gov Identifier: NCT00002129     History of Changes
Other Study ID Numbers: 234A
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:

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