Short Course of Miltefosine and Liposomal Amphotericin B for Kala-Azar
Information source: Banaras Hindu University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Liposomal amphotericin B and Miltefosine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Banaras Hindu University Official(s) and/or principal investigator(s):
Shyam Sundar, MD, Principal Investigator, Affiliation: Banaras Hindu University
Prabhat K Sinha, MD, Principal Investigator, Affiliation: Rajendra Memorial Research Institute of Medical Sciences
Overall contact:
Shyam Sundar, MD, Phone: 91-621-228-7570, Email: drshyamsundar@hotmail.com
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.
Clinical Details
Official title: The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Final Cure six months after the end of treatment
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 end of treatment the initial cure (clinical and parasitological
cure) and the clinical response will be determined. If initial cure is observed, a patient
will be evaluated after a 6 months (after end of treatment) follow up period for final
clinical cure.
Number of patients planned Total number of patients planned: 150 patients at both centers
combined. 75 pediatric (2-11 years); 75 adult (12-65 years).
Lack of suitability for the trial:
- Post Kala-azar Dermal Leishmaniasis (PKDL)
- Concomitant treatment with other anti-leishmanial drugs
- Any condition which compromises ability to comply with the study procedures
Administrative reasons:
- Any condition or situation that compromises compliance with study procedures including
follow-up visit Study medication, dose and mode of administration Liposomal
amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)
Dosage:
1. weighing ≥ 25 kg: 100 mg miltefosine daily as one capsule (50 mg) in the morning and
one capsule in the evening, after meals for 14 days.
2. weighing < 25 kg: 50 mg miltefosine daily as one capsule (50 mg) in the morning, after
meals for 14 days. Parameter for evaluation
- Final cure rate (initial parasite cure and clinical assessment at six month EOT)
- Initial parasitological cure rate (based on splenic aspirates or Bone marrow
aspirate)
- Clinical response at end of treatment (clinical assessment)
- Adverse events
Statistical methods
- Calculation of cure rate with 95% and 90% lower confidence limit according to Clopper
Pearson
- Calculation of overall incidence of adverse events
Eligibility
Minimum age: 2 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Shyam Sundar, MD, Phone: 91-621-228-7570, Email: drshyamsundar@hotmail.com
Kala-azar Medical Research Center, Muzaffarpur, Bihar 842001, India; Recruiting
Shyam Sundar, MD, Phone: 91-621-228-7570, Email: kamrcmfp@hotmail.com
Shyam Sundar, MD, Principal Investigator
Rajendra Memorial Research Institute of Medical Sciences, Patna, Bihar, India; Recruiting
Prabhat K Sinha, MD, Phone: 91-612-263-1561, Email: pksinha18@yahoo.com
Prabhat K Sinha, Md, Principal Investigator
Additional Information
Starting date: October 2007
Ending date: October 2008
Last updated: September 11, 2008
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