Pharmacokinetics of Miltefosine in Children and Adults

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
• Collaborator: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Treatments: Miltefosine

Criteria

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