Status:
TERMINATED
Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
Addis Ababa University
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
4+ years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00832208
Start Date
April 1 2009
End Date
March 1 2011
Last Update
January 21 2016
Active Locations (3)
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1
Gondar
Gonder, Gondar, Ethiopia
2
Arba Minch LRTC
Arba Minch, Ethiopia
3
Kassab Hospital
Kassāb, Gedarif, Sudan