Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832208
Recruitment Status : Terminated
First Posted : January 30, 2009
Last Update Posted : January 21, 2016
Addis Ababa University
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Brief Summary:
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 or disease Intervention/treatment Phase
Visceral Leishmaniasis Drug: Liposomal amphotericin B (Ambisome) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Parasitological clearance at day 30. [ Time Frame: Day 30 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832208

Layout table for location information
Arba Minch LRTC
Arba Minch, Ethiopia
Gondar, Ethiopia
Kassab Hospital
Kassab, Gedarif, Sudan
Sponsors and Collaborators
Drugs for Neglected Diseases
Addis Ababa University
Layout table for investigator information
Principal Investigator: Sisay Yifru, MD Gondar University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Drugs for Neglected Diseases Identifier: NCT00832208    
Other Study ID Numbers: AMBI 0106
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents