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

Launched by JANSSEN, LP · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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).