Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.

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

Details

• Lead Sponsor: Banaras Hindu University
• Collaborator: Rajendra Memorial Research Institute of Medical Sciences
• Treatments: Amphotericin B; Liposomal amphotericin B; Miltefosine

Criteria

Inclusion Criteria:

• Male and female age between 2 and 65 years (inclusive)

• Parasites visualized on splenic aspiration

• Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)

• Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate

• Fever for at least 2 weeks

• Written informed consent from the patient/or from parent or guardian if under 18 years old

Exclusion Criteria:

• Hemoglobin < 6 g/dl

• White blood cell count < 1000/mm3

• Platelets <50,000

• Prothrombin time > 5 sec above control

• ASAT > 3 times the upper limit of normal

• Serum creatinine or BUN > 1.5 times the upper limit of normal

• Malaria

• Tuberculosis

• HIV positive serology

• Lactation, pregnancy

• Refusing contraception method during treatment period plus 3 months

• Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs

• Any concomitant drug that is nephrotoxic