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Completed

NCT Number: NCT00523965

Combination Therapy in Indian Visceral Leishmaniasis

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.

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Key information

Conditions

Leishmaniasis, Visceral Euglenozoa Infections Infections Leishmaniasis Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kala-azar Medical Research Center

Muzaffarpur, Bihar, 842001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 5 years old with symptoms and signs of kala-azar (fever, weight loss, splenomegaly) and parasites demonstrated by microscopy in splenic aspirate smear

Exclusion criteria

  • Pregnant or breast-feeding women
  • Individuals seropositive to HIV or individuals with a serious concurrent infection such as tuberculosis or bacterial pneumonia.
  • Women of child-bearing age will be counseled about adequate birth control during and for three months after miltefosine treatment and provided with a satisfactory method of contra-ception.
  • Granulocyte count < 1,000/mm3, hemoglobin < 5 g/dL or platelet count < 40,000/mm3
  • Hepatic transaminases or total bilirubin greater than three times normal
  • Serum creatinine > 2.0 mg/dL
  • Prothrombin time > 5 seconds above control
  • Inability of subject or guardian to provide written informed consent

Treatment and study plan

amphotericin B deoxycholate

Drug

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

Liposomal Amphotericin B with Miltefosine

Drug

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

Liposomal Amphotericin B and Paromomycin Sulfate

Drug

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

miltefosine + Paromomycin sulfate

Drug

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

Primary outcomes

  1. Final cure at six month follow up

    Time frame: 18 months

  2. Cure at six month follow up

    Time frame: 12 months

Secondary outcomes

  1. Initial cure at the end of treatment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Collaborators

  • Drugs for Neglected Diseases
  • Rajendra Memorial Research Institute of Medical Sciences

Registry information

Official study title

A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in Visceral Leishmaniasis (VL)

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Sep 3, 2007
Registry last updated
May 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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