Study of Itraconazole in Patients With Advanced HIV Infection

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002370
• Other study ID #: 254B
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Itraconazole

Locations

Country	Name	City	State
United States	Erie County Med Ctr / Pharmacy D	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Janssen, LP

Country where clinical trial is conducted

United States,