An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refrac… (NCT00002133) | Clinical Trial Compass
CompletedNot Applicable
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
United States
Plain-language summary
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Who can participate
Age range18 Years – 65 Years
SexALL
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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).