This study was an open evaluation of the efficacy and safety of Ketoconazole, 15 mg/kg/day orally for 3 weeks in 7 evaluable patients with Visceral Leishmaniasis in Kenya. Of all the seven patients who received ketoconazole, none had appreciable clearance of parasites from the splenic aspirate smears that were microscopically examined. All the splenic aspirate cultures done on these patients in the three weeks remained positive for leishmania parasites. Splenic sizes of these patients generally remained unchanged throughout the study period. The mean haemoglobin at the start of treatment was not different from that at the end of treatment. Liver function tests throughout treatment remained unchanged, i.e. within normal limits. It is concluded that Ketoconazole, 15 mg/kg/day orally given to these patients was not effective as an antileishmania drug although there was a one log drop in the parasite load. However, no serious side effect were noted in all of the patients during treatment.

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