Amphotericin B Treatment in Visceral Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00310505
First received: April 3, 2006
Last updated: September 11, 2008
Last verified: September 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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, deoxycholate drug combination
Amphotericin B
Liposomal amphotericin B
Deoxycholic Acid
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 19, 2014