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

Sponsor:	Drugs for Neglected Diseases
Collaborator:	Addis Ababa University
Information provided by:	Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:	NCT00832208

Purpose

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.

Condition	Intervention	Phase
Visceral Leishmaniasis	Drug: Liposomal amphotericin B (Ambisome)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Amphotericin B

U.S. FDA Resources

Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Parasitological clearance at day 30. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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
Experimental: Ambisome test Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg)	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

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832208

Locations

Ethiopia
Arba Minch LRTC
Arba Minch, Ethiopia
Gondar
Gondar, Ethiopia
Sudan
Kassab Hospital
Kassab, Gedarif, Sudan

Sponsors and Collaborators

Drugs for Neglected Diseases

Addis Ababa University

Investigators

Principal Investigator:

Sisay Yifru, MD

Gondar University

More Information

No publications provided by Drugs for Neglected Diseases

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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®) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial. Trials. 2011 Mar 6;12:66.

Responsible Party:	Sally Ellis, Drugs for Neglected Disease Initiative
ClinicalTrials.gov Identifier:	NCT00832208 History of Changes
Other Study ID Numbers:	AMBI 0106
Study First Received:	January 29, 2009
Last Updated:	March 9, 2011
Health Authority:	Ethiopia: Drug Administration and Control Authority

Additional relevant MeSH terms:

Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Amphotericin B

Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012