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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka America Pharmaceutical
• Treatments: Vesnarinone

Criteria

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).