Combination Chemotherapy for the Treatment of Indian Kala-Azar

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