Leishmaniasis, Visceral Clinical Trial
Official title:
A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in Visceral Leishmaniasis (VL)
Rationale
The overall objective of this trial is to identify a safe and effective combination,
(co-administration) short course treatment for the treatment of VL which could be easily
deployed in a control programme. The hypothesis is that the combination treatment is as
effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of
parasite resistance occurring. Safety and tolerability should be such that the combination
can be easily deployed.
Objective
The specific primary and secondary objectives are as follows:
Primary objective:
To identify a short course combination treatment regimen which is at least as effective as a
single dose of AmBisome 5mg/kg
Secondary objective:
To compare safety and tolerability of the various treatments measured by vital signs, blood
biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse
event reporting
Primary Endpoint:
The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of
treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6
months post treatment.
Parasitology is only carried out at any time during follow-up or at six months post
treatment if there are signs or symptoms of VL infection.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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