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

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ClinicalTrials.gov Identifier: NCT00002159

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

Study Description

Brief Summary:

To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Condition or disease	Intervention/treatment	Phase
HIV Infections Histoplasmosis Blastomycosis	Drug: Itraconazole Drug: Amphotericin B	Phase 3

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 Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	60 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Histoplasmosis

Drug Information available for: Amphotericin B Itraconazole Liposomal Amphotericin B

Genetic and Rare Diseases Information Center resources: Blastomycosis

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002159

Locations


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
Community Hosp
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 Collaborators

Janssen, LP

More Information


ClinicalTrials.gov Identifier:	NCT00002159 History of Changes
Other Study ID Numbers:	254A ITR-USA-118
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	December 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:


Itraconazole Histoplasmosis Antifungal Agents Acquired Immunodeficiency Syndrome	Amphotericin B AIDS-Related Complex Blastomycosis Antibiotics, Antifungal

Additional relevant MeSH terms:


HIV Infections Histoplasmosis Blastomycosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycoses Dermatomycoses Skin Diseases, Infectious Infection	Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Itraconazole Hydroxyitraconazole Amphotericin B Liposomal amphotericin B Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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