Amphotericin B Treatment in Visceral Leishmaniasis - Full Text View

Sponsor:	Banaras Hindu University
Information provided by:	Banaras Hindu University
ClinicalTrials.gov Identifier:	NCT00310505

Purpose

This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Condition	Intervention
Visceral Leishmaniasis	Drug: Amphotericin B deoxycholate given as daily administration

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised Double Blind Dose Ranging Study of Amphotericin B in 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

Estimated Enrollment:	1500
Study Start Date:	January 2003

Detailed Description:

This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.

Eligibility

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

Criteria

Inclusion Criteria:

Parasitologically proved kala-azar

Exclusion Criteria:

HIV positive serology

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310505

Locations

India, Bihar
Kala-azar Medical Research Center
Muzaffarpur, Bihar, India, 221005

Sponsors and Collaborators

Banaras Hindu University

Investigators

Principal Investigator:

Shyam Sundar, MD

Professor of Medicine

More Information

No publications provided by Banaras Hindu University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sundar S, Chakravarty J, Rai VK, Agrawal N, Singh SP, Chauhan V, Murray HW. Amphotericin B treatment for indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions. Clin Infect Dis. 2007 Sep 1;45(5):556-61. Epub 2007 Jul 23.

Study ID Numbers:	SS01MZP03
Study First Received:	April 3, 2006
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00310505 History of Changes
Health Authority:	India: Ministry of Health

Keywords provided by Banaras Hindu University:

visceral leishmaniasis
amphotericin B
Kala-azar

Additional relevant MeSH terms:

Abelcet
Anti-Infective Agents
Antiprotozoal Agents
Skin Diseases, Parasitic
Mastigophora Infections
Liposomal amphotericin B
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Cholagogues and Choleretics
Deoxycholic Acid
Antibiotics, Antifungal

Parasitic Diseases
Leishmaniasis, Visceral
Amphotericin B-deoxycholate
Amebicides
Leishmaniasis
Amphotericin B
Protozoan Infections
Skin Diseases
Gastrointestinal Agents
Pharmacologic Actions
Skin Diseases, Infectious
Sarcomastigophora Infections

ClinicalTrials.gov processed this record on February 08, 2010