Visceral Leishmaniasis
Conditions
Keywords
Visceral leishmaniasis, India, Liposomal Amphotericin B, Amphotericin B deoxycholate
Brief summary
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.
Detailed description
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India. Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.
Interventions
DRUGLiposomal Amphotericin B
a single dose of 10 mg/kg of liposomal amphotericin B
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
Sponsors
Banaras Hindu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Children and adults 2-65 years of age (inclusive) of either gender. * Diagnosis of VL confirmed by spleen or bone marrow aspirate. * Clinical signs and symptoms compatible with VL. * Biochemical and haematological test values as follows: * Haemoglobin \> 3.5g/100mL * White blood cell count \> 0.75 x109/L * Platelet count \> 40 x 109/L * AST, ALT and alkaline phosphatase \< 5 times upper normal limit * Prothrombin time \< 4 seconds above control * Serum creatinine levels - 1.5 times upper normal limit * Serum potassium levels within normal limits * HIV negative.
Exclusion criteria
* A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study. * Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up. * Proteinuria (\> 2+). * A history of allergy or hypersensitivity to amphotericin B * Previous treatment for VL within two weeks of enrollment into the study. * Prior treatment failures with amphotericin B.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final cure rate at six months after the end of treatment | One year |
Secondary
| Measure | Time frame |
|---|---|
| Initial cure after the end of treatment | six months |
Countries
India
Outcome results
None listed