A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring vesnarinone
Eligibility 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.
Sites / Locations
- UCLA School of Medicine