Pharmacokinetics of Miltefosine in Children and Adults (PK)
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics of Miltefosine in Children and Adults: Implications for the Treatment of Cutaneous Leishmaniasis in Colombia.|
- Intracellular and plasma concentration of miltefosine [ Time Frame: Participants will be followed up to 26 weeks. ] [ Designated as safety issue: No ]
- Parasite burden in lesions and extralesional tissues. [ Time Frame: Participants will be followed up to 26 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||December 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days
Children (2-12 years of age) and adults (18-60 years of age) will receive Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days.
Other Name: pharmacokinetic
An open-label phase IV clinical trial of miltefosine, designed to evaluate intracellular and plasma drug pharmacokinetics in children and adults using a population pharmacokinetics design. Two study groups have been defined: 1) children 2-12 years of age (n=30) and 2) adults 18-60 years of age (n=30) with confirmed parasitological diagnosis of cutaneous leishmaniasis. The participants will receive supervised standard treatment with miltefosine: 1.8 - 2.5 mg/Kg of weight for 28 days.
Miltefosine concentration will be determined in plasma and Peripheral Blood Mononuclear Cell (PBMCs), from 3 or 10ml peripheral blood samples in children and adults respectively. Sampling will be conducted pre-dosing at days 0,1,15 and 29 during treatment, and at months 1, 2, 3 and 6 post-treatment.
A population pharmacokinetics analysis will be performed using a non-linear model of mixed effects with the software Nonlinear Mixed-effects Model (NONMEM), R and Piranha. Parasite burden will be determined by 7SLRNA Quantitative Polymerase Chain Reaction (qPCR) of Leishmania from swab samples of lesions and extralesional tissues before and at the end of treatment. The relationship between pharmacokinetics and parasite persistence/burden will be determined by correlation analysis and pharmacodynamic modeling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462500
|Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas|
|Cali, Valle, Colombia, 5930|
|Principal Investigator:||Nancy C Saravia, PhD||Centro Internacional de Entrenamiento e Investigaciones Médicas, CIDEIM|