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Completed

NCT Number: NCT00310505

Amphotericin B Treatment in Visceral Leishmaniasis

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.

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Key information

Conditions

Visceral Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Visceral Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

2 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kala-azar Medical Research Center

Muzaffarpur, Bihar, 221005, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parasitologically proved kala-azar

Exclusion criteria

  • HIV positive serology

Treatment and study plan

Amphotericin B deoxycholate given as daily administration

Drug

Primary outcomes

  1. Final cure rate at six months after the end of treatment

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Registry information

Official study title

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

Important dates

Study start
2003
First posted
Apr 4, 2006
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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