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

June 23, 2005 updated by: Janssen, LP
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Station / Infectious Division
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Univ of Arkansas for Med Sciences
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Division of Infectious Diseases
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Division of Inf Diseases/ Indiana Univ Hosp
      • Indianapolis, Indiana, United States, 46218
        • Community Hosp
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • LSU Med Ctr / Div of Pulmonary & Critical Care Med
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Ann Arbor Veterans Administration Med Ctr
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Infectious Diseases Association / Research Med Ctr
      • Kansas City, Missouri, United States, 641082792
        • Univ of Missouri / Division of Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen, LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 254A
  • ITR-USA-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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