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Amphotericin B Treatment in Visceral Leishmaniasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310505
First Posted: April 4, 2006
Last Update Posted: September 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Banaras Hindu University
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parasitologically proved kala-azar

Exclusion Criteria:

  • HIV positive serology
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00310505     History of Changes
Other Study ID Numbers: SS01MZP03
First Submitted: April 3, 2006
First Posted: April 4, 2006
Last Update Posted: September 12, 2008
Last Verified: September 2008

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
Anti-Bacterial Agents
Antifungal Agents
Cholagogues and Choleretics
Gastrointestinal Agents