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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.

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

UAB Station / Infectious Division

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

Univ of Arkansas for Med Sciences

πŸ‡ΊπŸ‡Έ

Little Rock, Arkansas, United States

Division of Infectious Diseases

πŸ‡ΊπŸ‡Έ

Atlanta, Georgia, United States

Division of Inf Diseases/ Indiana Univ Hosp

πŸ‡ΊπŸ‡Έ

Indianapolis, Indiana, United States

Community Hosp

πŸ‡ΊπŸ‡Έ

Indianapolis, Indiana, United States

LSU Med Ctr / Div of Pulmonary & Critical Care Med

πŸ‡ΊπŸ‡Έ

Shreveport, Louisiana, United States

Ann Arbor Veterans Administration Med Ctr

πŸ‡ΊπŸ‡Έ

Ann Arbor, Michigan, United States

Univ of Missouri / Division of Infectious Diseases

πŸ‡ΊπŸ‡Έ

Kansas City, Missouri, United States

Infectious Diseases Association / Research Med Ctr

πŸ‡ΊπŸ‡Έ

Kansas City, Missouri, United States

UAB Station / Infectious Division
πŸ‡ΊπŸ‡ΈBirmingham, Alabama, United States

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