NCT00832208

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

January 29, 2009

Last Update Submit

January 20, 2016

Conditions

Visceral Leishmaniasis

Outcome Measures

Primary Outcomes (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.

    at 6 months post treatment

Secondary Outcomes (1)

  • Parasitological clearance at day 30.

    Day 30

Study Arms (2)

Ambisome control:

ACTIVE COMPARATOR

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)

Ambisome test

EXPERIMENTAL

Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg)

Drug: Liposomal amphotericin B (Ambisome)

Interventions

Liposomal amphotericin B (Ambisome)DRUG

21.0 mg/kg total dose. Given iv as 3mg/kg/day on days 1,2,3,4,5, and 14 and 21

Also known as: Ambisome
Ambisome control:

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gondar

Gonder, Gondar, Ethiopia

Location

Arba Minch LRTC

Arba Minch, Ethiopia

Location

Kassab Hospital

Kassāb, Gedarif, Sudan

Location

Related Publications (2)

  • Khalil EA, Weldegebreal T, Younis BM, Omollo R, Musa AM, Hailu W, Abuzaid AA, Dorlo TP, Hurissa Z, Yifru S, Haleke W, Smith PG, Ellis S, Balasegaram M, EL-Hassan AM, Schoone GJ, Wasunna M, Kimutai R, Edwards T, Hailu A. Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial. PLoS Negl Trop Dis. 2014 Jan 16;8(1):e2613. doi: 10.1371/journal.pntd.0002613. eCollection 2014.

    PMID: 24454970DERIVED

  • Edwards T, Omollo R, Khalil EA, Yifru S, Musa B, Musa A, Wasunna M, Smith PG, Royce C, Ellis S, Balasegaram M, Hailu A. Single-dose liposomal amphotericin B (AmBisome(R)) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials. 2011 Mar 6;12:66. doi: 10.1186/1745-6215-12-66.

    PMID: 21375777DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Sisay Yifru, MD

    Gondar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

ET(2)SU(1)