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A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
This study has been completed.
Study NCT00002131   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002131 on ClinicalTrials.gov Archive Site
 
 
 
A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma

To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.

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).

Phase II
Interventional
Treatment, Open Label, Safety Study
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Vesnarinone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
28
 
 

Inclusion Criteria

Concurrent Medication:

Allowed:

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

Concurrent Treatment:

Allowed:

  • 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:

Excluded:

  • 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:

Excluded:

  • 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:

Excluded:

  • 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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002131
 
234D, 22-93-254
Otsuka America Pharmaceutical
 
 
NIH AIDS Clinical Trials Information Service
April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP