Browsing MSF Research Protocols by Subjects
Now showing items 1-3 of 3
Research Protocol - A randomized trial of AmBisome monotherapy and combination of AmBisome and miltefosine for the treatment of VL in HIV positive patients in Ethiopia followed by secondary VL prophylactic treatment with pentamidineGeneral Objectives The overall objective of this trial is to identify a safe and effective treatment for VL in HIV coinfected patients. Primary Objective: To evaluate at day 29 assessment the efficacy of a combination regimen of AmBisome® + miltefosine and AmBisome® monotherapy in Ethiopian co-infected HIV + VL patients. Secondary Objectives: 1. To evaluate relapse-free survival at day 390 (after initial cure at day 29 or cure at day 58 after extended treatment). 2. To assess safety of the regimens. Other objectives: 1.To evaluate of viral load and CD4 count in all patients 2. To evaluate the pharmacokinetics of ARV, Ambisome and miltefosine and immune function markers in a subset of patients
Research Protocol - Post-kala-azar Dermal Leishmaniasis (PKDL): a prospective observational study of the effectiveness and safety of an ambulatory short course treatment with AmBisome* 15 mg/kg total doseGeneral 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.