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A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002159
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002159 on ClinicalTrials.gov Archive Site
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A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis

To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.

Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.

Interventional
Phase 3
Primary Purpose: Treatment
  • HIV Infections
  • Histoplasmosis
  • Blastomycosis
  • Drug: Itraconazole
  • Drug: Amphotericin B
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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
60
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Inclusion Criteria

Patients must have:

  • HIV positive or negative status.
  • Blastomycosis or histoplasmosis.
  • Life expectancy of at least 1 week.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Liver disease.
  • Self-limiting fungal disease.
  • Very severe fungal disease such as meningeal involvement.
  • Acute respiratory disease.

Concurrent Medication:

Excluded at any time:

  • Terfenadine.
  • Astemizole.
  • Oral midazolam.
  • Triazolam.
  • Cisapride.
  • Phenytoin.
  • Phenobarbital.
  • Rifampin.
  • Rifabutin.

Excluded during oral consolidation:

  • H2 blockers.
  • Chronic antacids.
  • Omeprazole.
  • Lansoprazole.

Patients with the following prior condition are excluded:

Hypersensitivity to azole antifungals.

Prior Medication:

Excluded at any time:

More than 3 days of amphotericin B, fluconazole, or ketoconazole.

Excluded within 2 weeks prior to study entry:

  • Phenytoin.
  • Phenobarbital.
  • Rifampin.
  • Rifabutin.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002159
254A, ITR-USA-118
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Janssen, LP
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NIH AIDS Clinical Trials Information Service
December 1997

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