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 - Full Text View

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 3


Study Type:	Interventional
Study Design:	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 NLM:

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

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


Estimated Enrollment:	60

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

Choosing 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


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

No publications provided


ClinicalTrials.gov Identifier:	NCT00002159 History of Changes
Other Study ID Numbers:	254A, ITR-USA-118
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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:


Blastomycosis Histoplasmosis Dermatomycoses Infection Mycoses Skin Diseases Skin Diseases, Infectious Amphotericin B Hydroxyitraconazole Itraconazole Liposomal amphotericin B	14-alpha Demethylase Inhibitors Amebicides Anti-Bacterial Agents Anti-Infective Agents Antifungal Agents Antiparasitic Agents Antiprotozoal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015