Expired Study
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Buffalo, New York 14215


Purpose:

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.


Study 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.


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.


NCT ID:

NCT00002370


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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