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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Janssen, LP


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002438

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections
Histoplasmosis

Drug : Itraconazole

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002438

Locations

United States, Indiana
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Infectious Diseases of Indianapolis
Indianapolis, Indiana, United States, 46280
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, United States, 64132
United States, Tennessee
ASCC
Memphis, Tennessee, United States, 38103
Dr Michael Threikeld
Memphis, Tennessee, United States, 38105
Dr Mark A Pierce
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Janssen, LP
More Information

More Information


Responsible Party: Janssen, LP  
ClinicalTrials.gov Identifier: NCT00002438   History of Changes  
Other Study ID Numbers: 235B  
  MSG 28  
  ITR-USA-73  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Itraconazole
Histoplasmosis
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Histoplasmosis
Acquired Immunodeficiency Syndrome
Itraconazole
Hydroxyitraconazole

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.