Abstract

The combination of one intravenous administration of 5 mg/kg Ambisome and oral administration of miltefosine, 2.5 mg/kg/day for 14 days, was evaluated in 135 Indian patients with kala-azar. The Intent-to-Treat cure rate at 6 months was 124 of the 135 enrolled patients (91.9%: 95% CI = 86–96%), and the per protocol cure rate was 124 of 127 evaluable patients (97.6%: 95% CI = 93–100%). Side effects could be attributed to each drug separately: fevers, rigors and back pain due to Ambisome; gastrointestinal side effects due to miltefosine. This combination is attractive for reasons of efficacy, tolerance, and feasibility of administration, although the gastrointestinal side effects of miltefosine require medical vigilance. Clinical Trials.gov identification number: NCT00371995.

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