Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Phase 3

Completed

• Conditions: Visceral Leishmaniasis
• Interventions: Drug: Liposomal Amphotericin B; Drug: amphotericin B deoxycholate

• Registration Number: NCT00628719
• Lead Sponsor: Banaras Hindu University

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-05
• Primary Completion: 2008-08
• Study Completion: 2009-03
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-02
• Last Update Posted: 2009-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Liposomal Amphotericin B	a single dose of 10 mg/kg of liposomal amphotericin B
2	amphotericin B deoxycholate	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.

Primary Outcome Measures

Name	Time	Method
Final cure rate at six months after the end of treatment	One year

Secondary Outcome Measures

Name	Time	Method
Initial cure after the end of treatment	six months

Trial Locations

Locations (1)

Kala-azar Medical Research Center, Rambag Road; 🇮🇳 Muzaffarpur, India