Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh

• Status: Completed
• Trial end date: 2015-10-14
• Target enrollment: 0
• Participant gender: All

Summary

The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.

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

Details

• Lead Sponsor: Medecins Sans Frontieres, Netherlands
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

-Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)

Exclusion Criteria:

• PKDL and concurrent VL

• Prior treatment for PKDL

• On medication with a side effect profile overlapping with that of AmBisome

• A known hypersensitivity to AmBisome

• Pregnant and lactating women,

• Known cardiac disease, hepatic impairment or another severe chronic underlying disease -Renal impairment (baseline serum creatinine > 1.3 mg/dL)

• Serum potassium <3.5mmol/L at baseline