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

Visceral Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00832208
• Other study ID #: AMBI 0106
• Status: Terminated
• Phase: Phase 2
• First received: January 29, 2009
• Last updated: January 20, 2016
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: January 2016
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethiopia: Drug Administration and Control Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

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
• 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.

Locations

Country	Name	City	State
Ethiopia	Arba Minch LRTC	Arba Minch
Ethiopia	Gondar	Gondar
Sudan	Kassab Hospital	Kassab	Gedarif

Sponsors (2)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases	Addis Ababa University

Countries where clinical trial is conducted

Ethiopia,  Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Parasitological clearance at day 30.		Day 30	No