To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, United States
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Infectious Diseases Research Clinic / Indiana Univ Hosp
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