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A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

Primary Purpose

HIV Infections, Histoplasmosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Itraconazole
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, Acquired Immunodeficiency Syndrome

Eligibility Criteria

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

Inclusion Criteria Patients must have: 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 Co-existing Condition: 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.

Sites / Locations

  • Infectious Diseases Research Clinic / Indiana Univ Hosp
  • Infectious Diseases of Indianapolis
  • Univ of Missouri at Kansas City School of Medicine
  • Infectious Diseases Association / Research Med Ctr
  • ASCC
  • Dr Michael Threikeld
  • Dr Mark A Pierce

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
NCT00002438
Brief Title
A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
Official Title
Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
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 and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Histoplasmosis
Keywords
Itraconazole, Histoplasmosis, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Itraconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: 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 Co-existing Condition: 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.
Facility Information:
Facility Name
Infectious Diseases Research Clinic / Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Infectious Diseases of Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Infectious Diseases Association / Research Med Ctr
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
ASCC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Dr Michael Threikeld
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Dr Mark A Pierce
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients

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