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Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

NCT01067443 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2017-04-24

No results posted yet for this study

Summary

This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

Conditions

  • Primary Visceral Leishmaniasis

Interventions

DRUG

Liposomal amphotericin B (AmBisome®) and sodium stibogluconate

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

DRUG

Liposomal amphotericin B + miltefosine

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

DRUG

Miltefosine

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Paladin Labs Inc.

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Monique Wasunna, MD · Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Kenya
  • Sudan

Study Locations

More Related Trials

Entities

Companies

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 NCT01067443 on ClinicalTrials.gov