Clinical trial NCT00002370: Study of Itraconazole in Patients With Advanced HIV Infection
Official title: Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Itraconazole
Administration, Oral
Antifungal Agents
Acquired Immunodeficiency Syndrome
Drug Administration Schedule
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Erie County Med Ctr / Pharmacy D
state: New York
Study officials:
References: