Study of Itraconazole in Patients With Advanced HIV Infection

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 HIV disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Hydroxyitraconazole; Itraconazole

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.