Status:
COMPLETED
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
Lead Sponsor:
Banaras Hindu University
Collaborating Sponsors:
Rajendra Memorial Research Institute of Medical Sciences
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
2-65 years
Phase:
PHASE2
Brief 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, follo...
Detailed Description
Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15). At two weeks after the en...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00371995
Start Date
October 1 2007
End Date
February 1 2010
Last Update
June 22 2011
Active Locations (2)
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1
Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 842001
2
Rajendra Memorial Research Institute of Medical Sciences
Patna, Bihar, India