Search / Trial NCT00002130

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

Launched by OTSUKA AMERICA PHARMACEUTICAL · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Antiviral Agents Vesnarinone

ClinConnect Summary

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.

Gender

ALL

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.

About Otsuka America Pharmaceutical

Otsuka America Pharmaceutical, Inc. is a leading biopharmaceutical company committed to improving the health and quality of life for patients through innovative research and development. A subsidiary of Otsuka Pharmaceutical Co., Ltd., based in Japan, Otsuka America focuses on delivering novel therapeutic solutions in areas such as mental health, nephrology, and oncology. With a strong emphasis on scientific integrity and collaboration, the company engages in clinical trials to advance its pipeline of drug candidates, striving to address unmet medical needs and enhance patient outcomes. Otsuka America is dedicated to ethical practices and upholding the highest standards in clinical research.

Locations

Atlanta, Georgia, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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