A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
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To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.
Condition or disease
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
Antiretroviral agents, including ddI, ddC, and AZT.
Investigational HIV drugs/therapies including vaccines.
Steroids (other than topical).
Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
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.
AZT, ddI, and ddC within 14 days prior to study entry.
Prior cytotoxic chemotherapy.
Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.
Mitsuyasu R, Bort L, Miles SA, Hardy WD, Petit RG. Preliminary results of a phase I study of vesnarinone (OPC-8212) in HIV-infected persons with CD4 > 300 cells/MM3. Int Conf AIDS. 1994 Aug 7-12;10(1):8 (abstract no 005B)