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NCT Number: NCT01067443

Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

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Key information

Conditions

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

Age range

7 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kimalel Health Centre, Kimalel, Kenya

Loading trial locations.

About this study

The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
  • Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
  • Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
  • HIV negative status

Exclusion criteria

  • Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
  • Patients with a negative lymph node/bone marrow (or spleen) smears.
  • Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI </= 15, Children W/H<70, presence of oedema)
  • Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
  • Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
  • Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
  • Patients with previous history of cardiac arrhythmia or an abnormal ECG
  • Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
  • Patients with haemoglobin < 5gm/dl.
  • Patients with WBC < 1 x 10³/mm³.
  • Patients with platelets < 40,000/mm³.
  • Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
  • Patients with serum creatinine outside the normal range for age and gender.
  • Major surgical intervention within 2 weeks prior to enrolment.

Treatment and study plan

Liposomal amphotericin B (AmBisome®) and sodium stibogluconate

Drug

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

Liposomal amphotericin B + miltefosine

Drug

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

Miltefosine

Drug

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Primary outcomes

  1. Initial cure: proportion cured at Day 28

    Time frame: Day 28

Secondary outcomes

  1. Final cure: proportion cured at day 210

    Time frame: 6 months post treatment

  2. Adverse events and serious adverse events occurring in the three study arms

    Time frame: up to day 60

Sponsors and collaborators

Lead sponsor

Drugs for Neglected Diseases

Other

Collaborators

  • Gilead Sciences
  • Paladin Labs Inc.

Registry information

Official study title

A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2010
Registry last updated
Apr 24, 2017

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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