NCT01067443

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

A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 7 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.

Conditions

• Primary Visceral Leishmaniasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-02-11
• Last updated: 2017-04-24

Locations

3 sites across 2 countries: Kenya, Sudan