Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Banaras Hindu University

Status and phase: Completed; Phase 3

Conditions: Visceral Leishmaniasis

Treatments: Drug: Liposomal Amphotericin B; Drug: amphotericin B deoxycholate

Study type: Interventional

Funder types: Other

Identifiers

NCT00628719

AA KAMRC

Details and patient eligibility

About

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

1

Experimental group

Description:

a single dose of 10 mg/kg of liposomal amphotericin B

Treatment:

Drug: Liposomal Amphotericin B

2

Active Comparator group

Description:

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.

Treatment:

Drug: amphotericin B deoxycholate