Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Otsuka America Pharmaceutical |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002131 |
To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Vesnarinone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma |
Estimated Enrollment: | 28 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within 30 days prior to study entry:
Prior Treatment:
Excluded within 30 days prior to study entry:
United States, California | |
UCLA School of Medicine | |
Los Angeles, California, United States, 900121973 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 |
Study ID Numbers: | 234D, 22-93-254 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002131 |
Health Authority: | United States: Food and Drug Administration |
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antiviral Agents vesnarinone |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Soft tissue sarcomas Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Vesnarinone Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Cardiotonic Agents Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic |
Enzyme Inhibitors Cardiovascular Agents Infection Protective Agents Antiviral Agents Pharmacologic Actions Neoplasms Phosphodiesterase Inhibitors Therapeutic Uses Lentivirus Infections Neoplasms, Vascular Tissue |