Clotrimazole troche vs. itraconazole oral solution in the treatment of oral candidosis in AIDS patients

This prospective study was designed to compare the efficacy and safety of i traconazole oral solution with those of clotrimazole troche in the treatmen t of oropharyngeal candidosis in acquired immunodeficiency syndrome (AIDS) patients. Patients were excluded if they had been treated with any antifung al agents 2 weeks prior to the study entry, were pregnant or nursing, or ha d significant liver disease. Twenty-nine patients (20 men and nine women), with a mean age of 32 years (15-62 years), were randomly, observer-blind tr eated with clotrimazole troche (10 mg, five times daily) or itraconazole or al solution (100 mg/10 mL, twice daily) for 1 week. Clinical and mycologic assessment were carried out on four consecutive days, in week 1, week 2, an d week 4 after the start of treatment. Clinical evaluation was assessed by a scoring method (0-3, absent to severe) as follows: soreness, change in ta ste, erythema, removable white plaque, and extent of lesions. Mycologic ass essment was performed by KOH preparation and fungal culture. Global evaluat ion, which is a summary of clinical and mycologic assessment at the end of treatment, was classified as cure (all signs and symptoms resolved with no evidence of infection), improvement (decrease in clinical score without com plete resolution), or failure (lack of improvement or further deterioration ). (Pons V, Greenspan D, Debruin M. Therapy for oropharyngeal candidiasis i n HIV-infected patients: a randomized, prospective multicenter study of ora l fluconazole versus clotrimazole troches. J Acquir Immune Defic Syndr 1993 ; 6: 1311-1316.) Global evaluation at week 2 and week 4 was made in terms o f no relapse or relapse. Any intercurrent medical events, whether human imm unodeficiency virus (HIV)-related or not, were recorded. An intention-to-tr eat analysis was employed. Data were analyzed using the chi-squared test, M ann-Whitney U-test, and Student's t-test.