Clinical Trial: 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
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary: 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.
Sponsor: Drugs for Neglected Diseases
Current Primary Outcome: Initial cure: proportion cured at Day 28 [ Time Frame: Day 28 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Final cure: proportion cured at day 210 [ Time Frame: 6 months post treatment ]
- Adverse events and serious adverse events occurring in the three study arms [ Time Frame: up to day 60 ]
Original Secondary Outcome: Same as current
Information By: Drugs for Neglected Diseases
Dates:
Date Received: February 10, 2010
Date Started: March 2010
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017
