Clinical trial: 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 itraconazole oral solution with those of clotrimazole troche in the treatment of oropharyngeal candidosis in acquired immunodeficiency syndrome (AIDS) patients. Patients were excluded if they had been treated with any antifungal agents 2 weeks prior to the study entry, were pregnant or nursing, or had 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 treated with clotrimazole troche (10 mg, five times daily) or itraconazole oral 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, and 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 taste, erythema, removable white plaque, and extent of lesions. Mycologic assessment was performed by KOH preparation and fungal culture. Global evaluation, 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 complete resolution), or failure (lack of improvement or further deterioration). (Pons V, Greenspan D, Debruin M. Therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, prospective multicenter study of oral 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 of no relapse or relapse. Any intercurrent medical events, whether human immunodeficiency virus (HIV)-related or not, were recorded. An intention-to-treat analysis was employed. Data were analyzed using the chi-squared test, Mann-Whitney U-test, and Student's t-test.

RCT Entities:   Population Interventions Outcomes