Itraconazole oral solution for treatment of fluconazole resistant oral/esophageal candidosis in HIV-infected patients: Results of a prospective multicenter study I. Clinical assessment

Objective. To evaluate the efficacy and safety of itraconazole oral solutio n in candidosis unresponsive to fluconazole we performed a prospective, mul ticenter, pilot study in thirteen hospitals in France. Patients and treatment. Sixty AIDS patients with oral and/or esophageal can didosis persisting despite fluconazole treatment of at least 14 days at a m inimum daily dose of 100 mg (oral candidosis) or 200 mg (esophageal candido sis) received itraconazole oral solution (100 mg b.i.d. for 14 days, then 2 00 mg b.i.d. for 14 days if not clinically cured at day 14). Results. Forty-five patients were assessed for efficacy. At day 14, 60 % of patients were clinically cured; the other patients were all improved. At t he end of treatment (day 14 or 28), 67 % of patients (78 % of those with or al candidosis and 47 % of those with oral and esophageal candidosis) were c linically cured. Mycology became negative in 21 % of cases. Three of the fi ve patients receiving concomitant rifampin or rifabutin were cured. Clinica l response was not strictly correlated with itraconazole plasma levels, whi ch may reflect an additional topical activity. No significant adverse event was observed. Conclusion. Itraconazole oral solution is effective and well tolerated in f luconazole resistant candidosis in AIDS patients.