Candidiasis, Oral, HIV Infections
Conditions
Keywords
Itraconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Candidiasis, Oral
Brief summary
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
Detailed description
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.
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: * 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).
Countries
United States
Outcome results
None listed