Back to resultsCombination Chemotherapy for the Treatment of Indian Kala-Azar
Primary Purpose
Visceral Leishmaniasis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Combination therapy with AmBisome and miltefosine
Sponsored by
About this trial
This is an interventional treatment trial for Visceral Leishmaniasis focused on measuring Visceral leishmaniasis, miltefosine, AmBisome, Combination
Eligibility Criteria
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
Sites / Locations
- Kala-azar Medical Research Center
Outcomes
Primary Outcome Measures
Absence of clinical kala-azar at six month follow up
Secondary Outcome Measures
Full Information
NCT ID
NCT00370825
First Posted
August 31, 2006
Last Updated
September 11, 2008
Sponsor
Banaras Hindu University
1. Study Identification
Unique Protocol Identification Number
NCT00370825
Brief Title
Combination Chemotherapy for the Treatment of Indian Kala-Azar
Official Title
Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Banaras Hindu University
4. Oversight
5. Study Description
Brief Summary
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Leishmaniasis
Keywords
Visceral leishmaniasis, miltefosine, AmBisome, Combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Combination therapy with AmBisome and miltefosine
Primary Outcome Measure Information:
Title
Absence of clinical kala-azar at six month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyam Sundar, MD
Organizational Affiliation
Banaras Hindu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kala-azar Medical Research Center
City
Muzaffarpur
State/Province
Bihar
ZIP/Postal Code
842001
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
18781879
Citation
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. doi: 10.1086/591972.
Results Reference
derived
Learn more about this trial
Combination Chemotherapy for the Treatment of Indian Kala-Azar
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