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

This study has been completed.
Sponsor:
Collaborator:
Rajendra Memorial Research Institute of Medical Sciences
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00371995
First received: September 5, 2006
Last updated: June 21, 2011
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Visceral Leishmaniasis
Drug: Liposomal amphotericin B and Miltefosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India

Resource links provided by NLM:


Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Final Cure six months after the end of treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2007
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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)

Drug: Liposomal amphotericin B and Miltefosine

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)

Other Name: AmBisome and Impavido

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

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371995

Locations
India
Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 842001
Rajendra Memorial Research Institute of Medical Sciences
Patna, Bihar, India
Sponsors and Collaborators
Banaras Hindu University
Rajendra Memorial Research Institute of Medical Sciences
Investigators
Principal Investigator: Shyam Sundar, MD Banaras Hindu University
Principal Investigator: Prabhat K Sinha, MD Rajendra Memorial Research Institute of Medical Sciences
  More Information

Publications:
Responsible Party: Shyam Sundar, Professor, Banaras Hdindu University
ClinicalTrials.gov Identifier: NCT00371995     History of Changes
Other Study ID Numbers: LEI PDE 06 03
Study First Received: September 5, 2006
Last Updated: June 21, 2011
Health Authority: India: Ministry of Health

Keywords provided by Banaras Hindu University:
Visceral leishmaniasis
kala-azar
miltefosine
AmBisome

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Amphotericin B
Liposomal amphotericin B
Miltefosine
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014