Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial

Objective To test short course, low dose liposomal amphotericin B as single or daily infusion treatment in Indian visceral leishmaniasis (kala-azar). Design Randomised, open label study. Setting Inpatient unit for leishmaniasis in Bihar, India. Participants 91 adults and children with splenic aspirate positive for infe ction. Interventions Total dose of 5 mg/kg of liposomal amphotericin B given as a single infusion (n = 46) or as once daily infusions of 1 mg/kg for five day s (n = 45). Main outcome measures Clinical and parasitological cure assessed 14 days af ter treatment and long term definitive cure (healthy, no relapse) at six mo nths. Results All but one person in each group had an initial apparent cure. Duri ng six months of follow up, three patients in the single dose group and two in the five dose group relapsed. Complete response (definitive cure) was t herefore achieved in 84 of 91 subjects (92%): 42 of 46 patients in the sing le dose group (91%, 95% confidence interval 79% to 98%) and 42 of 45 in the five dose group (93%, 82% to 99%). Response rates in the two groups were n ot significantly different. Conclusion Low dose liposomal amphotericin B (5 mg/kg), given either as a f ive day course or as a single infusion, seems to be effective for visceral leishmaniasis and wan-ants further testing.