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A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma | Clinical Trials | Clareo Health

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

NCT00002131•Otsuka America Pharmaceutical

View on ClinicalTrials.gov

Summary

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

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+1 more criteria

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).
+24 more criteria

Locations (2)

UCLA School of Medicine

Los Angeles, California, United States

Northwestern Univ Med School

Chicago, Illinois, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

Sarcoma, KaposiHIV Infections

Interventions

Vesnarinone

DRUG

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HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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