Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002132
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 NCT00002132 on ClinicalTrials.gov Archive Site
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Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.

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Interventional
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Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Candidiasis, Esophageal
  • HIV Infections
  • Drug: Itraconazole
  • Drug: Fluconazole
Not Provided
Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7.

*   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:

  • Esophageal candidiasis.
  • Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
  • HIV infection or other predisposing risk factor.
  • Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
  • Evidence of systemic fungal infection.
  • Underlying clinical condition that would preclude study completion.
  • Judged to be unreliable in regard to following physician's directives.

Concurrent Medication:

Excluded:

  • Rifampin.
  • Rifabutin.
  • Phenobarbital.
  • Phenytoin.
  • Carbamazepine.
  • Terfenadine.
  • Astemizole.
  • H2 blockers.
  • Continual antacids.
  • Any investigational drug (expanded access drugs are allowed).

Patients with the following prior conditions are excluded:

  • History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
  • History of hypersensitivity to imidazole or azole compounds.

Prior Medication:

Excluded:

  • Other orally administered antifungal therapy within 3 days prior to study entry.
  • Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002132
236A, ITR-USA-12
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Janssen Pharmaceuticals
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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