Combination Chemotherapy for the Treatment of Indian Kala-Azar

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2

Details

• Lead Sponsor: Banaras Hindu University
• Treatments: Amphotericin B; Liposomal amphotericin B; Miltefosine

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