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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

Primary Purpose

HIV Infections, Histoplasmosis, Blastomycosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Itraconazole
Amphotericin B
Sponsored by
Janssen, LP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Itraconazole, Histoplasmosis, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Blastomycosis, Antibiotics, Antifungal

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB Station / Infectious Division
  • Univ of Arkansas for Med Sciences
  • Division of Infectious Diseases
  • Division of Inf Diseases/ Indiana Univ Hosp
  • Community Hosp
  • LSU Med Ctr / Div of Pulmonary & Critical Care Med
  • Ann Arbor Veterans Administration Med Ctr
  • Univ of Missouri / Division of Infectious Diseases
  • Infectious Diseases Association / Research Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT00002159
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Janssen, LP

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Histoplasmosis, Blastomycosis
Keywords
Itraconazole, Histoplasmosis, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Blastomycosis, Antibiotics, Antifungal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Itraconazole
Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UAB Station / Infectious Division
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Univ of Arkansas for Med Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Division of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Division of Inf Diseases/ Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46218
Country
United States
Facility Name
LSU Med Ctr / Div of Pulmonary & Critical Care Med
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Ann Arbor Veterans Administration Med Ctr
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Univ of Missouri / Division of Infectious Diseases
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
641082792
Country
United States
Facility Name
Infectious Diseases Association / Research Med Ctr
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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