Study of Itraconazole in Patients With Advanced HIV Infection
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 1997
History of Changes
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.
Drug : Itraconazole
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- 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.
- Change in antiretroviral therapy.
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:
Patients with the following prior symptoms and conditions are excluded:
Excluded within 15 days prior to study entry:
Excluded within 8 weeks prior to study entry:
Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
Contacts and LocationsChoosing 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
Locations Show More
|United States, New York|
|Erie County Med Ctr / Pharmacy D|
|Buffalo, New York, United States, 14215|
Sponsors and CollaboratorsJanssen, LP
|Responsible Party:||Janssen, LP|
|ClinicalTrials.gov Identifier:||NCT00002370 History of Changes|
|Other Study ID Numbers:||254B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Itraconazole
Acquired Immunodeficiency Syndrome
Drug Administration Schedule
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.