Candidiasis, Oral, HIV Infections
Conditions
Keywords
Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
Brief summary
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
Detailed description
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
Interventions
DRUGItraconazole
Sponsors
Janssen, LP
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Co-existing Condition: 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. Concurrent Medication: Excluded: * Rifampin. * Rifabutin. * Phenobarbital. * Phenytoin. * Carbamazepine. * Terfenadine. * Astemizole. * 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. Prior Medication: Excluded: * Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.
Countries
United States
Outcome results
None listed