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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Janssen, LP
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002159

Purpose

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

Condition	Intervention	Phase
HIV Infections Histoplasmosis Blastomycosis	Drug: Itraconazole Drug: Amphotericin B	Phase III

Study Type:	Interventional
Study Design:	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 NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Itraconazole Amphotericin B

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, United States, 64132
Univ of Missouri / Division of Infectious Diseases
Kansas City, Missouri, United States, 641082792

Sponsors and Collaborators

Janssen, LP

More Information

No publications provided

Study ID Numbers:	254A, ITR-USA-118
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002159 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Abelcet
Anti-Infective Agents
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Blastomycosis
Histoplasmosis
Infection
Liposomal amphotericin B
Itraconazole
Hydroxyitraconazole
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Antifungal Agents

Therapeutic Uses
Antibiotics, Antifungal
Amebicides
Retroviridae Infections
Amphotericin B
RNA Virus Infections
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Skin Diseases, Infectious
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 27, 2009