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Study of Itraconazole in Patients with Advanced HIV Infection



Study of Itraconazole in Patients with Advanced HIV Infection

For Condition: HIV Infections
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 36

Location and Contact Information:

Erie County Med Ctr / Pharmacy D
Buffalo,  New York,  14215
United States
 


Additional Information:
Study ID Numbers:  254B; 
Study Start Date: 
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002370

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