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Pharmacokinetics of Miltefosine in Children and Adults (PK)

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ClinicalTrials.gov Identifier: NCT01462500
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):

Study Description
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 response. The results will provide pharmacologic bases to optimize the use of miltefosine for the treatment of cutaneous leishmaniasis, and will provide the knowledge base to assess the impact of pharmacokinetic behavior in children and adults on the emergence of drug resistance.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Miltefosine Phase 4

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 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Miltefosine in Children and Adults: Implications for the Treatment of Cutaneous Leishmaniasis in Colombia.
Study Start Date : October 2011
Primary Completion Date : May 2014
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis
Drug Information available for: Miltefosine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Miltefosine
Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days
Drug: Miltefosine
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

Outcome Measures

Primary Outcome Measures :
  1. Intracellular and plasma concentration of miltefosine [ Time Frame: Participants will be followed up to 26 weeks. ]
  2. Parasite burden in lesions and extralesional tissues. [ Time Frame: Participants will be followed up to 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462500

Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas
Cali, Valle, Colombia, 5930
Sponsors and Collaborators
Centro Internacional de Entrenamiento e Investigaciones Médicas
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Nancy C Saravia, PhD Centro Internacional de Entrenamiento e Investigaciones Médicas, CIDEIM
More Information

Responsible Party: Centro Internacional de Entrenamiento e Investigaciones Médicas
ClinicalTrials.gov Identifier: NCT01462500     History of Changes
Other Study ID Numbers: 2229-519-28930
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by Centro Internacional de Entrenamiento e Investigaciones Médicas:
cutaneous leishmaniasis

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents