FLUCONAZOLE THERAPY OF ORAL CANDIDIASIS IN HIV-INFECTED PATIENTS - RESULTS OF A MULTICENTER STUDY

In an open phase-III study 103 HIV-positive patients with oral candidi asis were treated with oral fluconazole 100 mg/day for 7-21 days (mean 12.2 +/- 6.1 days). Ninety per cent of the patients presented with th e full clinical picture of AIDS, in 83% CD4-lymphocytes were < 100/mm( 3) Clinical and mycological (smear and mouth rinsing) examinations wer e performed at the start of therapy, after weeks 1, 2, and 3, and at t he end of therapy. The clinical findings showed fluconazole therapy to have achieved cure in 71% of the patients and improvement in 16%. The rapy failed in 13%. Mycological tests revealed elimination in 57% and reduction in colony counts in 23% of patients. Therapy failure accordi ng to mycological criteria was observed in 20% of all subjects. Advers e events were recorded for 26% of all patients. A causal connection wi th study therapy was considered as ''unlikely'' in 20 cases, ''questio nable'' in 17 cases, and ''likely'' in three cases. Premature disconti nuation of fluconazole therapy was required in seven patients, in thre e of them because of adverse events due to fluconazole. Even in patien ts with advanced HIV infection and consequently severe immunodeficienc y, fluconazole is an important improvement of the therapeutic spectrum .