To provide maintenance treatment with itraconazole solution for patients who were clinical
responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole
oral solution for up to 6 months.
Patients must have:
- Met criteria for clinical response on protocol FDA 236B with no residual visible
lesion of oropharyngeal candidiasis upon completion of that study OR had initial
response on protocol FDA 236B with subsequent relapse and retreatment with
itraconazole solution or other therapies.
- Life expectancy of at least 3 months.
Patients with the following symptoms or conditions are excluded:
- Underlying clinical condition that would preclude completion of study or place
subject at significant risk.
- Judged unreliable with respect to physician's directives.
- Systemic antifungals.
Patients with the following prior conditions are excluded:
- Previously documented disseminated candidiasis.
- Previous clinically significant adverse event during treatment with itraconazole oral
solution, unless clearly attributable to an intercurrent illness or condition.
- History of significant hepatic abnormalities or clinical evidence of significant
hepatic disease within 2 months prior to study entry.
- Any investigational drug (other than itraconazole solution) within 1 month prior to