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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
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.
Details
| Lead sponsor | Drugs for Neglected Diseases |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 151 |
| Start date | 2010-03 |
| Completion | 2011-06 |
Conditions
- Primary Visceral Leishmaniasis
Interventions
- Liposomal amphotericin B (AmBisome®) and sodium stibogluconate
- Liposomal amphotericin B + miltefosine
- Miltefosine
Primary outcomes
- Initial cure: proportion cured at Day 28 — Day 28
Countries
Kenya, Sudan