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.
Purpose
