Combination Chemotherapy for the Treatment of Indian Kala-Azar

This study has been completed.
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00370825
First received: August 31, 2006
Last updated: September 11, 2008
Last verified: September 2008

August 31, 2006
September 11, 2008
September 2006
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Absence of clinical kala-azar at six month follow up
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Complete list of historical versions of study NCT00370825 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy for the Treatment of Indian Kala-Azar
Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Visceral Leishmaniasis
Drug: Combination therapy with AmBisome and miltefosine
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Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis. 2008 Oct 15;47(8):1000-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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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
Both
12 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
India
 
NCT00370825
KAMRC0601
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Banaras Hindu University
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Principal Investigator: Shyam Sundar, MD Banaras Hindu University
Banaras Hindu University
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP