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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002130
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  Purpose

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 Intervention
HIV Infections
Drug: Vesnarinone

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: 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 NLM:


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

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.

  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, 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002130

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002130     History of Changes
Other Study ID Numbers: 234C, 22-93-253
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014