A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
NCT ID: NCT00002438
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Itraconazole
Eligibility Criteria
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Inclusion Criteria
* HIV infection.
* Residence in an area endemic for H. capsulatum.
* Absolute CD4 count \< 150 cells/mm3.
* No current or past active histoplasmosis.
* No other active fungal infection.
* Life expectancy of at least 1 year.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma.
* Inability to take oral medication.
Concurrent Medication:
Excluded:
* Systemically-active antifungals.
* Investigational drugs (expanded access drugs are acceptable).
* Rifampin.
* Rifabutin.
* Terfenadine.
* Astemizole.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* H2 blockers.
* Omeprazole.
* Continual antacids.
Patients with the following prior conditions are excluded:
History of intolerance to imidazole or azole compounds.
Prior Medication:
Excluded within 1 month prior to study entry:
* Investigational drugs (expanded access drugs are acceptable).
Excluded within 15 days prior to study entry:
* Rifampin.
* Rifabutin.
* Terfenadine.
* Astemizole.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
13 Years
ALL
No
Sponsors
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Janssen, LP
INDUSTRY
Locations
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Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States
Infectious Diseases of Indianapolis
Indianapolis, Indiana, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, United States
ASCC
Memphis, Tennessee, United States
Dr Michael Threikeld
Memphis, Tennessee, United States
Dr Mark A Pierce
Nashville, Tennessee, United States
Countries
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Other Identifiers
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MSG 28
Identifier Type: -
Identifier Source: secondary_id
ITR-USA-73
Identifier Type: -
Identifier Source: secondary_id
235B
Identifier Type: -
Identifier Source: org_study_id