Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis - Full Text View

Sponsor:	Banaras Hindu University
Information provided by:	Banaras Hindu University
ClinicalTrials.gov Identifier:	NCT00628719

Purpose

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.

Condition	Intervention	Phase
Visceral Leishmaniasis	Drug: Liposomal Amphotericin B Drug: amphotericin B deoxycholate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in 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 Banaras Hindu University:

Primary Outcome Measures:

Final cure rate at six months after the end of treatment [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Initial cure after the end of treatment [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	February 2008
Study Completion Date:	March 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 a single dose of 10 mg/kg of liposomal amphotericin B	Drug: Liposomal Amphotericin B a single dose of 10 mg/kg of liposomal amphotericin B Other Name: AmBisome
Active Comparator: 2 amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.	Drug: amphotericin B deoxycholate amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days. Other Name: Amphotericin B deoxycholate

Detailed Description:

The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.

Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates

Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.

Eligibility

Ages Eligible for Study:	2 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children and adults 2-65 years of age (inclusive) of either gender.
Diagnosis of VL confirmed by spleen or bone marrow aspirate.
Clinical signs and symptoms compatible with VL.
Biochemical and haematological test values as follows:
Haemoglobin > 3.5g/100mL
White blood cell count > 0.75 x109/L
Platelet count > 40 x 109/L
AST, ALT and alkaline phosphatase < 5 times upper normal limit
Prothrombin time < 4 seconds above control
Serum creatinine levels - 1.5 times upper normal limit
Serum potassium levels within normal limits
HIV negative.

Exclusion Criteria:

A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.
Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
Proteinuria (> 2+).
A history of allergy or hypersensitivity to amphotericin B
Previous treatment for VL within two weeks of enrollment into the study.
Prior treatment failures with amphotericin B.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628719

Locations

India
Kala-azar Medical Research Center, Rambag Road
Muzaffarpur, India, 842001

Sponsors and Collaborators

Banaras Hindu University

Investigators

Study Director:

Shyam Sundar, MD

Banaras Hindu University

More Information

No publications provided by Banaras Hindu University

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

Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12.

Responsible Party:	Professor Shyam Sundar, Banaras Hindu University
ClinicalTrials.gov Identifier:	NCT00628719 History of Changes
Other Study ID Numbers:	AA KAMRC
Study First Received:	February 20, 2008
Last Updated:	April 2, 2009
Health Authority:	India: Institutional Review Board

Keywords provided by Banaras Hindu University:

Visceral leishmaniasis
India
Liposomal Amphotericin B
Amphotericin B deoxycholate

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
Amphotericin B, deoxycholate drug combination

Deoxycholic Acid
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012