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

This study has been completed.

Sponsored by: Janssen, LP
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002438
  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

MedlinePlus related topics:   AIDS    Fungal Infections    Molds   

Drug Information available for:   Itraconazole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Safety Study
Official Title:   Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection
  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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

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

Locations
United States, Indiana
Infectious Diseases of Indianapolis    
      Indianapolis, Indiana, United States, 46280
Infectious Diseases Research Clinic / Indiana Univ Hosp    
      Indianapolis, Indiana, United States, 46202
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 Mark A Pierce    
      Nashville, Tennessee, United States, 37232
Dr Michael Threikeld    
      Memphis, Tennessee, United States, 38105

Sponsors and Collaborators
Janssen, LP
  More Information


Study ID Numbers:   235B, MSG 28, ITR-USA-73
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002438
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Itraconazole  
Histoplasmosis  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Histoplasmosis
Acquired Immunodeficiency Syndrome
Tioconazole
Itraconazole
Hydroxyitraconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
Antiparasitic Agents
Antiprotozoal Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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