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Amphotericin B Treatment in Visceral Leishmaniasis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00310505
Enrollment
1500
Registered
2006-04-04
Start date
2003-01-31
Completion date
Unknown
Last updated
2008-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral Leishmaniasis

Keywords

visceral leishmaniasis, amphotericin B, Kala-azar

Brief 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.

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.

Interventions

DRUGAmphotericin B deoxycholate given as daily administration

Sponsors

Banaras Hindu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Parasitologically proved kala-azar

Exclusion criteria

* HIV positive serology

Design outcomes

Primary

MeasureTime frame
Final cure rate at six months after the end of treatment

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026