Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis
Information source: Drugs for Neglected Diseases
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Liposomal amphotericin B (Ambisome) (Drug); Liposomal amphotericin B (Ambisome) (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Drugs for Neglected Diseases Official(s) and/or principal investigator(s):
Sisay Yifru, MD, Principal Investigator, Affiliation: Gondar University
Overall contact:
Asrat Hailu, Email: hailu_a2004@yahoo.com
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.
Clinical Details
Official title: Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: Parasitological clearance at day 30.
Eligibility
Minimum age: 4 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Asrat Hailu, Email: hailu_a2004@yahoo.com
Arba Minch LRTC, Arba Minch, Ethiopia
Gondar, Gondar, Ethiopia
Additional Information
Starting date: March 2009
Ending date: June 2011
Last updated: January 29, 2009
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