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Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis

NCT00696969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2010-02-11

No results posted yet for this study

Summary

The overall objective of this trial is to identify a safe and effective combination, (coadministration) short course treatment for the treatment of visceral leishmaniasis which could be easily deployed in a control programme and will reduce the risk of parasite resistance occurring.

Safety and tolerability should be such that the combination can be easily deployed.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Amphotericin B Deoxycholate

1 mg/kg e.o.d for 30 days

DRUG

Ambisome + Miltefosine

Ambisome (i.v. single dose 5 mg/kg)+ Miltefosine 7 days

DRUG

Ambisome and Paromomycin

Ambisome 5 mg/kg single dose + Paromomycin Sulphate 15mg/kg/day for 10 days

DRUG

Miltefosine and Paromomycin

Miltefosine (standard dose) and Paromomycin Sulphate 15mg/kg/day for 10 days

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Farrokh Modabber · Drugs for Neglected Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00696969 on ClinicalTrials.gov