Study of Itraconazole in Patients With Advanced HIV Infection

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002370

Run by

Janssen, LP

People needed

36

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

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

Full record on ClinicalTrials.gov

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