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

This study has been terminated.
Sponsor:
Collaborator:
Addis Ababa University
Information provided by:
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT00832208
First received: January 29, 2009
Last updated: March 9, 2011
Last verified: March 2011

January 29, 2009
March 9, 2011
April 2009
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00832208 on ClinicalTrials.gov Archive Site
Parasitological clearance at day 30. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis
Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Visceral Leishmaniasis
  • 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
  • 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
  • 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
    Intervention: Drug: Liposomal amphotericin B (Ambisome)
  • Experimental: Ambisome test
    Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg)
    Intervention: Drug: Liposomal amphotericin B (Ambisome)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
240
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia,   Sudan
 
NCT00832208
AMBI 0106
Yes
Sally Ellis, Drugs for Neglected Disease Initiative
Drugs for Neglected Diseases
Addis Ababa University
Principal Investigator: Sisay Yifru, MD Gondar University
Drugs for Neglected Diseases
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP