To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected
patients with CD4 count > 300 cells/mm3.
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.
- 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
- Antiretroviral agents, including ddI, ddC, and AZT.
- Immunosuppressive agents.
- Investigational HIV drugs/therapies including vaccines.
- Steroids (other than topical).
- Megestrol acetate.
- Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg
sulfamethoxazole thrice weekly.
- Cytotoxic chemotherapy.
- 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.
- 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
Active illicit drug abuse.