Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Miltefosine efficacy will be >85%

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Foundation
• Collaborator: World Health Organization
• Treatments: Miltefosine

Criteria

Inclusion Criteria:

• 12 years or older

• nodules and papules consistent with post kala-azar dermal leishmaniasis

• parasitological confirmation of Leishmania infection

Exclusion Criteria:

• platelet count <100x 109/l,

• leukocyte count <2.5 x 109/l ,

• hemoglobin < 8.0 g/100 ml ,

• liver function tests >3 times upper limit of normal range,

• bilirubin >2 times upper limit of normal range,

• serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range);

• any non-compensated or uncontrolled condition,

• lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;

• treatment with any anti-leishmanial drug within the previous 12 weeks.