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A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3



A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3

For Condition: HIV Infections
Status: Completed
Sponsor(s): Otsuka America Pharmaceutical ,
Synopsis: To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.
Details: Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.
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, mycobacteria, and herpes simplex. Patients must have: - Asymptomatic HIV infection. - CD4 count > 300 cells/mm3. - No prior AIDS-defining illness or current constitutional symptoms of HIV disease. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening. - Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix. Concurrent Medication: Excluded: - Antiretroviral agents, including ddI, ddC, and AZT. - Immunosuppressive agents. - Investigational HIV drugs/therapies including vaccines. - Interferon. - Steroids (other than topical). - Hematopoietins. - Megestrol acetate. - Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. - Cytotoxic chemotherapy. Concurrent Treatment: Excluded: - Radiation therapy. Patients with the following prior conditions are excluded: - Prior history of cardiac disease. - History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function. Prior Medication: Excluded: - AZT, ddI, and ddC within 14 days prior to study entry. - Prior cytotoxic chemotherapy. Prior Treatment: Excluded: - Radiation therapy (including electron beam irradiation) within 30 days prior to study entry. Active illicit drug abuse.
Total Enrollment: 36

Location and Contact Information:

UCLA School of Medicine
Los Angeles,  California,  900121973
United States
 


Additional Information:
Study ID Numbers:  234A;  22-93-251
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002129

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