Study of Itraconazole in Patients With Advanced HIV Infection

Launched by JANSSEN, LP · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.