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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
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 ClinicalTrials.gov Identifier (NCT Number):

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.

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

Keywords provided by Banaras Hindu University:

visceral leishmaniasis
amphotericin B
Kala-azar

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