Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis

Overview

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 Title of Study: “A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2008

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

  • Drug: Liposomal Amphotericin B
    • a single dose of 10 mg/kg of liposomal amphotericin B
  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • a single dose of 10 mg/kg of liposomal amphotericin B
  • Active Comparator: 2
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Final cure rate at six months after the end of treatment
    • Time Frame: One year

Secondary Measures

  • Initial cure after the end of treatment
    • Time Frame: six months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Banaras Hindu University
  • Provider of Information About this Clinical Study
    • Professor Shyam Sundar, Banaras Hindu University
  • Overall Official(s)
    • Shyam Sundar, MD, Study Director, Banaras Hindu University

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