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

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Janssen

Status

Completed

Conditions

Candidiasis, Esophageal
HIV Infections

Treatments

Drug: Itraconazole
Drug: Fluconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002132
ITR-USA-12
236A

Details and patient eligibility

About

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

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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