Protocol > Research Protocol
Diro EGJ, Griensven JV, Woldegebreal T, Belew Z, Taye M, et al.
2018 July 1
2.1 OBJECTIVES
2.1.1 General objective:
To document the effectiveness, safety and feasibility of monthly PM secondary prophylaxis (PSP) in VL/HIV co-infected patients that have documented parasite clearance after VL treatment when used for prevention of VL relapse.
2.1.2 Specific objectives of the primary study period
2.1.2.1 Primary objectives
In VL/HIV co-infected patients that have documented parasite clearance after VL treatment:
- to assess the effectiveness of PSP in terms of preventing relapse and death;
- to assess the safety of PSP in terms of drug-related serious adverse events or permanent drug discontinuations due to adverse events;
- to assess the feasibility of PSP in terms of number of patients compliant to therapy
during the first year of monthly PM secondary prophylaxis.
2.1.2.2 Secondary objectives;
In VL/HIV co-infected patients that have documented parasite clearance after VL treatment:
- to assess the safety of PSP in terms of:
- drug-related non-serious adverse events
- serious adverse events (drug-related or not)
- to assess the feasibility of PSP in terms of:
- number of treatment interruptions/discontinuations,
- number of therapeutic interventions needed to treat adverse drug reactions
2.1.1 General objective:
To document the effectiveness, safety and feasibility of monthly PM secondary prophylaxis (PSP) in VL/HIV co-infected patients that have documented parasite clearance after VL treatment when used for prevention of VL relapse.
2.1.2 Specific objectives of the primary study period
2.1.2.1 Primary objectives
In VL/HIV co-infected patients that have documented parasite clearance after VL treatment:
- to assess the effectiveness of PSP in terms of preventing relapse and death;
- to assess the safety of PSP in terms of drug-related serious adverse events or permanent drug discontinuations due to adverse events;
- to assess the feasibility of PSP in terms of number of patients compliant to therapy
during the first year of monthly PM secondary prophylaxis.
2.1.2.2 Secondary objectives;
In VL/HIV co-infected patients that have documented parasite clearance after VL treatment:
- to assess the safety of PSP in terms of:
- drug-related non-serious adverse events
- serious adverse events (drug-related or not)
- to assess the feasibility of PSP in terms of:
- number of treatment interruptions/discontinuations,
- number of therapeutic interventions needed to treat adverse drug reactions
Protocol > Research Protocol
Hailu ADE, Diro EGJ, Kolja S, Ritmeijer KKD, Yifru S, et al.
2018 July 1
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
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
Journal Article > ResearchFull Text
PLoS Negl Trop Dis. 2010 October 26; Volume 4 (Issue 10); DOI:10.1371/journal.pntd.0000709
Hailu ADE, Musa AM, Wasunna M, Balasegaram M, Yifru S, et al.
PLoS Negl Trop Dis. 2010 October 26; Volume 4 (Issue 10); DOI:10.1371/journal.pntd.0000709
Visceral leishmaniasis (VL) is a major health problem in developing countries. The untreated disease is fatal, available treatment is expensive and often toxic, and drug resistance is increasing. Improved treatment options are needed. Paromomycin was shown to be an efficacious first-line treatment with low toxicity in India.