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 pentamidine(2014-10)General 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 dose(2014-06)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.