A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1997
History of Changes
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Drug : Itraconazole
Drug : Amphotericin B
Primary Purpose: Treatment
|Official Title:||A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- HIV positive or negative status.
- Blastomycosis or histoplasmosis.
- Life expectancy of at least 1 week.
- Liver disease.
- Self-limiting fungal disease.
- Very severe fungal disease such as meningeal involvement.
- Acute respiratory disease.
- Oral midazolam.
- H2 blockers.
- Chronic antacids.
Patients with the following symptoms or conditions are excluded:
Excluded at any time:
Excluded during oral consolidation:
Patients with the following prior condition are excluded:
Hypersensitivity to azole antifungals.
Excluded at any time:
More than 3 days of amphotericin B, fluconazole, or ketoconazole.
Excluded within 2 weeks prior to study entry:
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: NCT00002159
Locations Show More
|United States, Alabama|
|UAB Station / Infectious Division|
|Birmingham, Alabama, United States, 35294|
|United States, Arkansas|
|Univ of Arkansas for Med Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Georgia|
|Division of Infectious Diseases|
|Atlanta, Georgia, United States, 30303|
|United States, Indiana|
|Division of Inf Diseases/ Indiana Univ Hosp|
|Indianapolis, Indiana, United States, 46202|
|Indianapolis, Indiana, United States, 46218|
|United States, Louisiana|
|LSU Med Ctr / Div of Pulmonary & Critical Care Med|
|Shreveport, Louisiana, United States, 71130|
|United States, Michigan|
|Ann Arbor Veterans Administration Med Ctr|
|Ann Arbor, Michigan, United States, 48105|
|United States, Missouri|
|Univ of Missouri / Division of Infectious Diseases|
|Kansas City, Missouri, United States, 641082792|
|Infectious Diseases Association / Research Med Ctr|
|Kansas City, Missouri, United States, 64132|
Sponsors and CollaboratorsJanssen, LP
|Responsible Party:||Janssen, LP|
|ClinicalTrials.gov Identifier:||NCT00002159 History of Changes|
|Other Study ID Numbers:||254A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Itraconazole
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Liposomal amphotericin B
ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.