Status:
COMPLETED
Combination Chemotherapy for the Treatment of Indian Kala-Azar
Lead Sponsor:
Banaras Hindu University
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00370825
Start Date
September 1 2006
Last Update
September 12 2008
Active Locations (1)
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1
Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 842001