Combination Therapy in Indian Visceral Leishmaniasis

Summary

Rationale

The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme. The hypothesis is that the combination treatment is as effective or better than the 5 mg/kg single dose of AmBisome and will reduce the risk of parasite resistance occurring. Safety and tolerability should be such that the combination can be easily deployed.

Objective

The specific primary and secondary objectives are as follows:

Primary objective:

To identify a short course combination treatment regimen which is at least as effective as a single dose of AmBisome 5mg/kg

Secondary objective:

To compare safety and tolerability of the various treatments measured by vital signs, blood biochemistry, (renal and liver function tests) haematology, spontaneous and elicited adverse event reporting

Primary Endpoint:

The primary efficacy endpoint variable is parasitological clearance 2 weeks after start of treatment with no relapse during follow up and no clinical signs or symptoms of VL at 6 months post treatment.

Parasitology is only carried out at any time during follow-up or at six months post treatment if there are signs or symptoms of VL infection.

Conditions

• Leishmaniasis, Visceral

Interventions

DRUG

amphotericin B deoxycholate

Amphotericin B deoxycholate 1 mg/kg on alternate days for 15 infusions

DRUG

Liposomal Amphotericin B with Miltefosine

Liposomal Amphotericin B 5 mg Miltefosine 50 mg twice daily if patient weighs equal to or \> 25 kg Miltefosine 50 mg once daily if patient weighs \<25 mg

DRUG

Liposomal Amphotericin B and Paromomycin Sulfate

AmBisome 5mg/kg iv infusion over 2 h x 1 day (single dose) + paromomycin sulfate 15 mg/kg/day i.m for 10 days, on day 2-11

DRUG

miltefosine + Paromomycin sulfate

oral miltefosine 50mg once daily (\< 25 kg body weight) or twice daily ( \> 25 kg body weight) or 2.5 mg/kg for children under 12 years, for 10 days + Paromomycin sulfate 15 mg/kg/day im. for 10 days

Sponsors & Collaborators

• Drugs for Neglected Diseases

  collaborator OTHER

• Rajendra Memorial Research Institute of Medical Sciences

  collaborator OTHER

• Banaras Hindu University

  lead OTHER

Principal Investigators

• Shyam Sundar, MD · Institute of Medical Sciences, Banaras HIndu University

• P K Sinha, MD · Rajendra Memorial Research Insititute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-09-30

Primary Completion

2009-08-31

Completion

2010-02-28

Countries

• India

Study Locations