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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002438
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002438 on ClinicalTrials.gov Archive Site
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A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • HIV Infections
  • Histoplasmosis
Drug: Itraconazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002438
235B, MSG 28, ITR-USA-73
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Janssen, LP
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NIH AIDS Clinical Trials Information Service
April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP