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

Phase 3

Completed

• Conditions: HIV Infections; Histoplasmosis; Blastomycosis

• Registration Number: NCT00002159
• Lead Sponsor: Janssen, LP

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 Timeline

• Status Verified: 1997-12
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (9)

Community Hosp; 🇺🇸 Indianapolis, Indiana, United States

LSU Med Ctr / Div of Pulmonary & Critical Care Med; 🇺🇸 Shreveport, Louisiana, United States

Univ of Arkansas for Med Sciences; 🇺🇸 Little Rock, Arkansas, United States

Division of Infectious Diseases; 🇺🇸 Atlanta, Georgia, United States

Division of Inf Diseases/ Indiana Univ Hosp; 🇺🇸 Indianapolis, Indiana, United States

UAB Station / Infectious Division; 🇺🇸 Birmingham, Alabama, United States

Ann Arbor Veterans Administration Med Ctr; 🇺🇸 Ann Arbor, Michigan, United States

Univ of Missouri / Division of Infectious Diseases; 🇺🇸 Kansas City, Missouri, United States

Infectious Diseases Association / Research Med Ctr; 🇺🇸 Kansas City, Missouri, United States