Fluconazole versus ketoconazole in the treatment of oropharyngeal candidiasis in HIV-infected children. Multicentre Study Group.

In an open multicentre study the efficacy and safety of fluconazole versus ketoconazole were evaluated in the treatment of 46 pediatric patients with oropharyngeal candidiasis and AIDS or HIV infection. Twenty-four subjects received oral fluconazole in a dosage of 3 mg/kg/day and 22 subjects received oral ketoconazole in a dosage of 7 mg/kg/day. The treatment duration ranged from 5 to 49 days. Results showed that fluconazole and ketoconazole have comparable efficacy and safety in the treatment of oropharyngeal candidiasis in HIV-infected children. Patients treated with fluconazole had higher clinical and mycological cure rates at the end of therapy (88% and 71% respectively) than those treated with ketoconazole (81% and 57% respectively). One case of drug-related side effects (diarrhea and abdominal pain) in a patient receiving ketoconazole resulted in discontinuation of treatment. Follow-up examinations 2 and 4 weeks post-treatment showed a comparably high rate of relapse in both patient groups.