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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002159

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: December 1997

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections Histoplasmosis Blastomycosis
Intervention ^ICMJE	Drug: Itraconazole Drug: Amphotericin B
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients must have: HIV positive or negative status. Blastomycosis or histoplasmosis. Life expectancy of at least 1 week. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Liver disease. Self-limiting fungal disease. Very severe fungal disease such as meningeal involvement. Acute respiratory disease. Concurrent Medication: Excluded at any time: Terfenadine. Astemizole. Oral midazolam. Triazolam. Cisapride. Phenytoin. Phenobarbital. Rifampin. Rifabutin. Excluded during oral consolidation: H2 blockers. Chronic antacids. Omeprazole. Lansoprazole. Patients with the following prior condition are excluded: Hypersensitivity to azole antifungals. Prior Medication: Excluded at any time: More than 3 days of amphotericin B, fluconazole, or ketoconazole. Excluded within 2 weeks prior to study entry: Phenytoin. Phenobarbital. Rifampin. Rifabutin.
Gender	Both
Ages	13 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00002159
Other Study ID Numbers ^ICMJE	254A, ITR-USA-118
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Janssen, LP
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1997
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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