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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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

Key facts

Study ID

NCT00002131

Run by

Otsuka America Pharmaceutical

People needed

28

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• Northwestern Univ Med School — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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