A DOSE COMPARISON STUDY OF A NEW TRIAZOLE ANTIFUNGAL (D0870) IN HIV-POSITIVE PATIENTS WITH ORAL CANDIDIASIS

Objective: This multicentre study evaluated the clinical efficacy and tolerability of D0870 in treating oropharyngeal candidiasis in HIV-pos itive patients who had no history of clinical resistance to fluconazol e. Methods: Three regimens were evaluated in two phases. in phase I a 50 mg initial dose was followed by 10 mg for 4 days (Group 1). In phas e II a 100 mg initial dose was followed by 25 mg for 4 days (Group 2), or 10 mg for 5 days (Group 3). Results: Clinical cure was obtained in 27 patients of a total of 35 (77%) and six other patients improved (1 7%). Two patients at the lowest dose failed and both had very low plas ma concentration of D0870. No association was found between clinical o utcome, minimum inhibitory concentration of D0870 pre-therapy for Cand ida albicans, maximum recorded plasma D0870 concentration, cfu of cult ure or CD4 cell count at entry. Overall, 37% of the patients experienc ed relapse during the 2 weeks post therapy. Tolerance was excellent. M ild adverse events possibly related to the study drug were recorded in five patients. Conclusion: D0870 demonstrates excellent efficacy at l ow doses in the treatment of HIV-related OPC and exhibits a favourable safety profile.