Combination Chemotherapy for the Treatment of Indian Kala-Azar

Banaras Hindu University

Status and phase

Completed

Phase 2

Conditions

Visceral Leishmaniasis

Treatments

Drug: Combination therapy with AmBisome and miltefosine

Study type

Interventional

Funder types

Other

Identifiers

NCT00370825

KAMRC0601

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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