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

Hdl Handle:
http://hdl.handle.net/10144/332058
Title:
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
Authors:
Hailu, Asrat; Diro, Ermias; Kolja, Stille; Ritmeijer, Koert; Yifru, Sisay; van Griensven, Johan; Zijlstra, Ed; Dorlo, Thomas
Abstract:
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
Affiliation:
Addis Ababa University, Addis Ababa, Ethiopia; University of Gondar, Gondar, Ethiopia; Médecins Sans Frontières, London, UK; Médecins Sans Frontières, Amsterdam, The Netherlands; University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium; Drugs for Neglected Diseases initiative, Geneva, Switzerland; Slotervaart Hospital, Amsterdam, The Netherlands
Issue Date:
Oct-2014
URI:
http://hdl.handle.net/10144/332058
Type:
Other
Language:
en
Description:
Research Protocol
Appears in Collections:
MSF Research Protocols

Full metadata record

DC FieldValue Language
dc.contributor.authorHailu, Asrat; Diro, Ermias; Kolja, Stille; Ritmeijer, Koert; Yifru, Sisay; van Griensven, Johan; Zijlstra, Ed; Dorlo, Thomasen_GB
dc.date.accessioned2014-10-02T16:27:23Z-
dc.date.available2014-10-02T16:27:23Z-
dc.date.issued2014-10-
dc.identifier.urihttp://hdl.handle.net/10144/332058-
dc.descriptionResearch Protocolen_GB
dc.description.abstractGeneral 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 patientsen_GB
dc.language.isoenen
dc.rightsThese materials can be used, adapted and copied as long as citation of the source is given including the direct URL to the material. This work is licensed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0/ https://i.creativecommons.org/l/by/4.0/88x31.pngen_GB
dc.subjectvisceral leishmaniasisen_GB
dc.subjectHIV/AIDSen_GB
dc.subjectAmBisomeen_GB
dc.subjectMiltefosineen_GB
dc.titleResearch 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 pentamidineen
dc.typeOtheren
dc.contributor.departmentAddis Ababa University, Addis Ababa, Ethiopia; University of Gondar, Gondar, Ethiopia; Médecins Sans Frontières, London, UK; Médecins Sans Frontières, Amsterdam, The Netherlands; University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium; Drugs for Neglected Diseases initiative, Geneva, Switzerland; Slotervaart Hospital, Amsterdam, The Netherlandsen_GB
All Items in MSF are protected by copyright, with all rights reserved, unless otherwise indicated.