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...

Date First Received: November 2, 1999

Last Updated: June 23, 2005

Verified by: NIH AIDS Clinical Trials Information Service, April 1996

Clinical Trial Phase: N/A | Start Date: 

Overall Status: Completed

Brief Summary

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

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Treatment, Double-Blind, Safety Study

Intervention(s) in this Clinical Trial

  • Drug: Itraconazole
  • Drug: Fluconazole

Criteria for Participation in this Clinical Trial

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Janssen, LP

Related Publications

References

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.

Additional Information

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002132

Study ID Number: 236A

ClinicalTrials.gov Identifier: NCT00002132

Health Authority: United States: Food and Drug Administration

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