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

Sponsor

Otsuka America Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00002131

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Vesnarinone	Phase 2

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).

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.