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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 - Article


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CD4


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

This study has been completed.

Sponsored by: Otsuka America Pharmaceutical
Information provided by: AIDS Clinical Trials Information Service

Purpose

To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Vesnarinone
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study

Further Study Details: 

Expected Total Enrollment:  36

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

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

Prior Treatment: Excluded:

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

Location Information


California
      UCLA School of Medicine, Los Angeles,  California,  900121973,  United States

More Information

Publications

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)

Study ID Numbers:  234A; 22-93-251
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002129
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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