Status:
COMPLETED
Pharmacokinetics of Miltefosine in Children and Adults
Lead Sponsor:
Centro Internacional de Entrenamiento e Investigaciones Médicas
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
2-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the pharmacokinetics of miltefosine in children and adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the parasitologic...
Detailed Description
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 g...
Eligibility Criteria
Inclusion
- Age: 2-12 years of age, or 18-60 years of age
- Weight greater than 10 kg
- Parasitologic confirmation of cutaneous leishmaniasis
- Normal hepatic and kidney function
Exclusion
- Pregnant or lactating women, and women who are planning to conceive during the study or that reject the use of birth control methods.
- Use of drugs with antileishmanial potential during the previous 6 months, including pentavalent antimonials, amphotericin B, miltefosine, and pentamidine
- Mucocutaneous or visceral leishmaniasis
- For female children, menses or other evidence of reproductive maturity
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01462500
Start Date
October 1 2011
End Date
December 1 2015
Last Update
August 22 2016
Active Locations (1)
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1
Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas
Cali, Valle del Cauca Department, Colombia, 5930