A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.

Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Vesnarinone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma

Resource links provided by NLM:

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

Estimated Enrollment: 28
Detailed Description:
Twenty-eight patients (14 per cohort) receive daily vesnarinone at one of two doses. At least seven patients at the lower dose must have completed 2 weeks of therapy before subsequent patients are entered at the higher dose. Patients who successfully complete 16 weeks of treatment may receive maintenance therapy for the duration of the study (approximately 12-18 months).

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

Inclusion Criteria

Concurrent Medication:


  • Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
  • Acyclovir as acute treatment for herpes outbreaks.

Concurrent Treatment:


  • Limited electron-beam radiation therapy to non-marker lesions for treatment of Kaposi's sarcoma.

Patients must have:

  • Documented HIV infection.
  • Kaposi's sarcoma.
  • No current constitutional signs of HIV disease or AIDS-defining conditions other than Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in situ carcinoma of the cervix.
  • Current significant cardiac disease or anomaly (including prolonged QTC on EKG).
  • Abnormal cardio-thoracic ratio on chest x-ray.

Concurrent Medication:


  • Antiretroviral agents, including ddI, ddC, AZT, and d4T.
  • Immunosuppressive agents.
  • Investigational HIV drugs/therapies including vaccines (except those on treatment IND for approved indications).
  • Other anti-Kaposi's sarcoma/HIV drugs.
  • Corticosteroids (other than topical).
  • Biologic response modifiers.
  • 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:


  • Radiation therapy including electron beam irradiation (other than limited electron-beam radiation to non-marker lesions for treatment of Kaposi's sarcoma).

Patients with the following prior conditions are excluded:

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

Prior Medication:


  • AZT within 14 days prior to study entry.
  • Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.

Excluded within 30 days prior to study entry:

  • Interferon.
  • Biologic response modifiers.
  • Cytotoxic chemotherapy.

Prior Treatment:

Excluded within 30 days prior to study entry:

  • Blood or cellular blood product. Active illicit drug abuse (specifically cocaine, amyl nitrate, heroin, or other cardioactive agents).
  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: NCT00002131

United States, California
UCLA School of Medicine
Los Angeles, California, United States, 900121973
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Otsuka America Pharmaceutical
  More Information

Petit RG, Miles S, Magpantay L, Mitsuyasu R. Vesnarinone inhibits AIDS-KS cells in culture. Int Conf AIDS. 1994 Aug 7-12;10(1):169 (abstract no PB0104)

ClinicalTrials.gov Identifier: NCT00002131     History of Changes
Other Study ID Numbers: 234D  22-93-254 
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:
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antiviral Agents

Additional relevant MeSH terms:
Sarcoma, Kaposi
DNA Virus Infections
Herpesviridae Infections
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Virus Diseases
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Cardiotonic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 26, 2016