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A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease

This study has been completed.

Sponsored by: Otsuka America Pharmaceutical
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002337
  Purpose

To evaluate the safety and tolerability of four doses of oral vesnarinone in patients with advanced HIV disease.


Condition Intervention Phase
HIV Infections
Drug: Vesnarinone
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Vesnarinone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   A Phase I Safety and Tolerability Study of Four Doses of OPC-8212 (Vesnarinone) in Advanced HIV Disease

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   56

Detailed Description:

Fourteen patients per dose level receive vesnarinone at 1 of 4 doses for 12 weeks. At least seven patients at a given dose level must have completed 4 weeks of treatment before dose is escalated in subsequent patients.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and other opportunistic infections.
  • Acyclovir for up to 14 days for acute herpes outbreaks.

Patients must have:

  • Documented HIV infection.
  • CD4 count 50 - 300 cells/mm3.
  • No active opportunistic infections.
  • No fever, diarrhea, or Herpes zoster.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinically significant current cardiac disease, including patients who exhibit long QTC syndrome on EKG screening and who have an abnormal cardiothoracic ratio on chest x-ray at baseline.
  • Active malignancy (other than cutaneous Kaposi's sarcoma or cutaneous basal cell carcinoma or in situ carcinoma of the cervix).

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).
  • Hematopoietins.
  • Megestrol acetate.
  • Agents known to cause neutropenia.
  • 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 or worse) drug-induced neutropenia or documented abnormalities in granulocyte function.

Prior Medication:

Excluded:

  • AZT, ddI, ddC, d4T, or other nucleoside analog antiretroviral therapy within 14 days prior to study entry.
  • Prior cytotoxic chemotherapy.
  • Acyclovir for herpes prophylaxis within 48 hours prior to study entry.

Prior Treatment:

Excluded within 30 days prior to study entry:

  • Erythropoietin, transfusion, or blood product use.
  • Radiation therapy (including electron beam irradiation). Active use of illicit drugs (specifically cocaine, amyl nitrate, heroin, and other cardioactive agents).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002337

Locations
United States, Georgia
AIDS Research Consortium of Atlanta    
      Atlanta, Georgia, United States, 30308

Sponsors and Collaborators
Otsuka America Pharmaceutical
  More Information


Study ID Numbers:   234B, 22-93-252
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002337
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Vesnarinone
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Cardiotonic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Cardiovascular Agents
Infection
Protective Agents
Antiviral Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008




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