An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Study Overview
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Brief Summary
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To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Detailed Description
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Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.

Official Title
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An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

Conditions
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Candidiasis, Oral, HIV Infections

Intervention / Treatment
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* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: HIV antibody seropositivity or diagnosis of AIDS. Confirmed oropharyngeal candidiasis. Failed fluconazole treatment within the past 14 days. Life expectancy of at least 3 months. NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present. NO prior disseminated candidiasis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Underlying clinical condition that precludes study completion or places the patient at significant risk. Considered unreliable about following physician's directives. Concurrent Medication: Excluded: Investigational drugs (approved expanded access drugs are permitted). Rifampin. Rifabutin. Phenobarbital. Phenytoin. Carbamazepine. Terfenadine. Astemizole. Patients with the following prior conditions are excluded: History of hypersensitivity to imidazole or azole compounds. Clinical evidence of significant hepatic disease within the past 2 months. Prior Medication: Excluded: Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Itraconazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral