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

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 Type: Interventional

Study Design: Treatment, Dose Comparison, Pharmacokinetics Study

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.

Intervention(s) in this Clinical Trial

• Drug: Itraconazole

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen, LP

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002370

Study ID Number: 254B

ClinicalTrials.gov Identifier: NCT00002370

Health Authority: United States: Food and Drug Administration