Study of Itraconazole in Patients With Advanced HIV Infection
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
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.
||Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
||Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry.
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.
- H2 blockers.
- Continual antacids.
- 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.
Excluded within 15 days prior to study entry:
Excluded within 8 weeks prior to study entry:
- Change in antiretroviral therapy.
Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002370
|Erie County Med Ctr / Pharmacy D
|Buffalo, New York, United States, 14215 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Drug Administration Schedule
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 02, 2015
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
14-alpha Demethylase Inhibitors
Molecular Mechanisms of Pharmacological Action