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Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL

This study has been terminated.
Addis Ababa University
Information provided by (Responsible Party):
Drugs for Neglected Diseases Identifier:
First received: January 29, 2009
Last updated: January 20, 2016
Last verified: January 2016
This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.

Condition Intervention Phase
Visceral Leishmaniasis
Drug: Liposomal amphotericin B (Ambisome)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis

Resource links provided by NLM:

Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • The primary efficacy variable is parasitological clearance with no relapse at 6 months post treatment (ie definitive cure) assessed by clinical status and confirmed by splenic or bone marrow aspiration. [ Time Frame: at 6 months post treatment ]

Secondary Outcome Measures:
  • Parasitological clearance at day 30. [ Time Frame: Day 30 ]

Enrollment: 124
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ambisome control:
Ambisome, Total dose 21.0 mg given as 7 x 3mg on days 1,2,3,4,5, and 14 and 21
Drug: Liposomal amphotericin B (Ambisome)
21.0 mg/kg total dose. Given iv as 3mg/kg/day on days 1,2,3,4,5, and 14 and 21
Other Name: Ambisome
Experimental: Ambisome test
Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg)
Drug: Liposomal amphotericin B (Ambisome)
liposomal amphotericin b given intravenously as single dose at 7.5 mg/kg increasing to 10, 12.5 and 15.0mg/kg depending on results of interim analyses.
Other Name: Ambisome


Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female adults and children aged 4 years or older with no upper age limit (in accordance with manufacturer's instructions)
  • Acute, symptomatic, VL proven by parasitological examination of splenic aspirate (or bone marrow aspirate) with initial parasite index of at least 2+
  • Haemoglobin >4g/dL
  • Fever for more than 2 weeks
  • Living within reachable distance of the trial site to enable attendance for follow-up visits
  • Written informed consent to participate (for children, by parent or guardian)
  • HIV negative status

Exclusion Criteria:

  • Patients 'in extremis' with signs/symptoms indicative of severe VL
  • Patients who have received any anti-leishmanial treatment within the last 6 months
  • Patients who have received any investigational (unlicensed) drugs during 6 months before recruitment
  • Known underlying chronic disease, such as severe cardiac, pulmonary, renal, or hepatic impairment.
  • Renal function tests (serum creatinine) outside the normal range
  • Liver function tests more than 3 times the normal range at study entry
  • Platelet count less than 40,000/ mm3
  • Known alcohol abuse
  • Pregnancy or lactation
  • Concomitant acute drug usage for malaria and bacterial infection, pneumonia within last 7 days
  • Known hypersensitivity to AmBisome or amphotericin B
  • Any other condition which may invalidate the trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT00832208

Arba Minch LRTC
Arba Minch, Ethiopia
Gondar, Ethiopia
Kassab Hospital
Kassab, Gedarif, Sudan
Sponsors and Collaborators
Drugs for Neglected Diseases
Addis Ababa University
Principal Investigator: Sisay Yifru, MD Gondar University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Drugs for Neglected Diseases Identifier: NCT00832208     History of Changes
Other Study ID Numbers: AMBI 0106
Study First Received: January 29, 2009
Last Updated: January 20, 2016

Additional relevant MeSH terms:
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Liposomal amphotericin B
Amphotericin B
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents processed this record on April 25, 2017