Study of Itraconazole in Patients With Advanced HIV Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itraconazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itraconazole, Administration, Oral, Antifungal Agents, Acquired Immunodeficiency Syndrome, Drug Administration Schedule