HIV Infections
Conditions
Keywords
Itraconazole, Administration, Oral, Antifungal Agents, Acquired Immunodeficiency Syndrome, Drug Administration Schedule
Brief 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.
Detailed description
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.
Interventions
DRUGItraconazole
Sponsors
Janssen, LP
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed