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Combination Chemotherapy for the Treatment of Indian Kala-Azar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370825
Recruitment Status : Completed
First Posted : September 1, 2006
Last Update Posted : September 12, 2008
Information provided by:
Banaras Hindu University

Brief Summary:
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.

Condition or disease Intervention/treatment Phase
Visceral Leishmaniasis Drug: Combination therapy with AmBisome and miltefosine Phase 2

Detailed Description:
In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine. Both the drugs will be used in different doses. Reference arm will consist only a single dose of amBisome at 5 mg/kg. After the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). Safety parameters will be evaluated on day 0, 8 and 16. An arm with an efficacy of less than 75% will be closed. There will be periodical assessment of study results after completion of 5 patients in each arm.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
Study Start Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Primary Outcome Measures :
  1. Absence of clinical kala-azar at six month follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever, splenomegaly).
  • Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes.
  • Male or female.
  • Ages 12 to 65 years.
  • Both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment).
  • WBC > 1,000/mm3.
  • Hemoglobin ≥ 4 g/dL

Exclusion Criteria:

  • Pregnancy or breast-feeding.
  • HIV positive serology.
  • ASAT, ALAT, AP ≥ 3 times upper limit of normal range.
  • Bilirubin ≥ 2 times upper limit of normal range.
  • Prothrombin time ≥ 5 seconds above control.
  • Serum creatinine or BUN ≥ 1.5 times upper limit of normal range.
  • Any medical condition or situation that compromises compliance with study procedures.
  • HIV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370825

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Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 842001
Sponsors and Collaborators
Banaras Hindu University
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Principal Investigator: Shyam Sundar, MD Banaras Hindu University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00370825    
Other Study ID Numbers: KAMRC0601
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: September 12, 2008
Last Verified: September 2008
Keywords provided by Banaras Hindu University:
Visceral leishmaniasis
Additional relevant MeSH terms:
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Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Antineoplastic Agents