Abstract
General objective
To evaluate the effectiveness and safety of PKDL treatment with AmBisome 15 mg/kg total dose, given over 15 days in 5 infusions (twice weekly) of 3mg/kg on an ambulatory basis in a primary health care setting.
Primary objective: to evaluate the effectiveness of AmBisome 15 mg/kg total dose at 12 M
Secondary objective:
• Evaluate the safety of AmBisome 3mg/kg x 5 infusions (twice weekly) (15 mg/kg total dose)
• Evaluate the occurrence of hypokalaemia
• Evaluate at which point in time lesions start to respond to treatment.