Study of Itraconazole in Patients With Advanced HIV Infection

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry. Patients must have: Documented HIV infection. CD4 lymphocyte count < 300 cells/mm3. No clinically significant abnormalities, elicited by history and physical examination. No clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry. Negative urine screening. No clinically significant abnormalities of electrocardiogram. Prior Medication: Allowed: Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days. Unable to swallow oral solution. Obesity greater than 25% of ideal body weight. Concurrent Medication: Excluded: Rifampin. Rifabutin. Phenobarbital. Phenytoin. Carbamazepine. Digoxin. Warfarin. Midazolam. Triazolam. Terfenadine. Astemizole. Cisapride. H2 blockers. Omeprazole. Continual antacids. Didanosine. Any medication known to affect absorption, metabolism or excretion of imidazole or azole compounds. Patients with the following prior symptoms and conditions are excluded: Previous hypersensitivity to azole antifungals. History of surgical procedure that may interfere with absorption of itraconazole. History of significant blood loss in the previous 30 days. Prior Medication: Excluded: Excluded within 15 days prior to study entry: Rifampin. Rifabutin. Phenobarbital. Phenytoin. Carbamazepine. Digoxin. Warfarin. Midazolam. Triazolam. Excluded within 8 weeks prior to study entry: Change in antiretroviral therapy. Risk Behavior: Excluded: Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.