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A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma Clinical research trials and A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma. A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma clinical trial. Subjects typically recieve the finest healthcare available for their A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma  A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Otsuka America Pharmaceutical ,
Synopsis: To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.
Details: 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:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 28
Location and Contact Information:
UCLA School of Medicine
Los Angeles, California, 900121973
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: 234D; 22-93-254
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002131
Other Sarcoma, Kaposi Studies:
1. A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
2. Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders
3. A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
4. A Study of HIV Levels During Pregnancy and After Childbirth
5. The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients with AIDS
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A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma
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