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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Fluconazole; Hydroxyitraconazole; Itraconazole

Criteria

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).