Evaluation of efficacy and safety of itraconazole oral solution for the treatment of oropharyngeal candidiasis in aids patients

ABSTRACT

This study was a non-comparative multicenter clinical trial to evaluate the efficacy and tolerability of itraconazole oral solution 200 mg/day (100 mg twice a day in the fasting state) for the treatment of oropharyngeal candidiasis in AIDS patients. We included 50 patients who were treated and followed for up 3 weeks after ending therapy in the analysis. Mycological cures at the end of therapy occurred in 20/50 patient (40 percent), but colonization by Candida sp. was recorded in 42/50 (84 percent) by the end of follow-up. A high rate of clinical response was observed in 46/50(92 percent), and the response was sustained for up to 21 days after stopping therapy in 24/46 patients (52 percent). Clinical relapse were documented among 22 patients, but all causative fungal organisms associated with a relapse were susceptible to itraconazole. There were many patients with persistence or recorrence of Candida, but without mucositis. Relapse of Candida mucositis was significantly related low levels of CD4 lymphocytes exhibited by symptomatic patients. The drug was well tolerated bt all but 1 patient. We conclude that itraconazole oral solution (100 mg bid for 7-14 days) is a well tolerated and effective treatment for suppressing the symptoms of oropharyngeal candidiasis in AIDS patients. Patients with severe immunosupression may relapse and require frequent cycles of treatment or longterm supressive therapy.