Amphotericin B Treatment in Visceral Leishmaniasis

Visceral Leishmaniasis Clinical Trial

Official title:

Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310505
• Other study ID #: SS01MZP03
• Status: Completed
• Phase: N/A
• First received: April 3, 2006
• Last updated: September 11, 2008
• Start date: January 2003

Study information

• Verified date: September 2008
• Source: Banaras Hindu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 65 Years

Eligibility

Inclusion Criteria:

• Parasitologically proved kala-azar

Exclusion Criteria:

• HIV positive serology

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Intervention

Drug:
• Amphotericin B deoxycholate given as daily administration

Locations

Country	Name	City	State
India	Kala-azar Medical Research Center	Muzaffarpur	Bihar

Sponsors (1)

Lead Sponsor	Collaborator
Banaras Hindu University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final cure rate at six months after the end of treatment