Amphotericin B Treatment in Visceral Leishmaniasis
Information source: Banaras Hindu University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Visceral Leishmaniasis
Intervention: Amphotericin B deoxycholate given as daily administration (Drug)
Phase: N/A
Status: Completed
Sponsored by: Banaras Hindu University Official(s) and/or principal investigator(s):
Shyam Sundar, MD, Principal Investigator, Affiliation: Professor of Medicine
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.
Clinical Details
Official title: Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Final cure rate at six months after the end of treatment
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
Minimum age: 2 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Parasitologically proved kala-azar
Exclusion Criteria:
- HIV positive serology
Locations and Contacts
Kala-azar Medical Research Center, Muzaffarpur, Bihar 221005, India
Additional Information
Starting date: January 2003
Last updated: April 6, 2006
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