To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma
concentration range comparable to that obtained after currently used oral dosages of
itraconazole oral solution; and to obtain preliminary safety data in patients with advanced
Patients will receive intravenous itraconazole solution twice daily for 2 days and then once
daily for five additional days. Patients then randomized to receive twice-daily or
once-daily itraconazole oral solution for an additional 28 days.
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
- 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.
Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8
weeks prior to study entry.
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.
- H2 blockers.
- Continual antacids.
- Any medication known to affect absorption, metabolism or excretion of imidazole or
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.
Excluded within 15 days prior to study entry:
Excluded within 8 weeks prior to study entry:
- Change in antiretroviral therapy.
Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.