Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146627
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2005-09-06
Brief Title:
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
Sponsor:
Drugs for Neglected Diseases
Organization:
Drugs for Neglected Diseases
Study Overview
Official Title:
Clinical Study Comparing the Nifurtimox-Eflornithine Combination With the Standard Eflornithine Regimen for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis in the Meningoencephalitic Phase
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the therapeutic combination of IV eflornithine oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety in patients suffering from Trypanosoma brucei gambiense Tbg human African trypanosomiasis HAT in the meningoencephalitic phase
Detailed Description:
Melarsoprol is the most commonly used product for the treatment of patients suffering from human African trypanosomiasis HAT in the meningoencephalitic second late phase This treatment is frequently complicated by fatal reactive encephalopathy and at the same time resistance is beginning to appear in various countries Eflornithine is effective and better tolerated but it is more difficult to use Nifurtimox registered in several South American countries for treatment of Chagas disease but used off label since the 1970s in series of cases of meningo-encephalitic HAT is at present the only other potential alternative for the treatment of late-stage HAT
The very limited number of compounds available the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations Ideally drug combinations should allow for reductions in the dosages of the drugs used in a way that in particular in the case of toxic drugs such as those used for second stage HAT the toxicity of the combination does not exceed that of either monotherapy Of the three drug combinations nowadays possible melarsoprol-nifurtimox melarsoprol-eflornithine and eflornithine-nifurtimox the last one has in two different dosing regimens shown the least treatment-associated toxicity and mortality in the 69 patients treated in one previous and this clinical trial to date Good tolerability was also observed in a case series of 31 patients The efficacy data to date suggest that efficacy is comparable to that of eflornithine and that of melarsoprol in areas without high melarsoprol failure rates
The very limited number of compounds available the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations Ideally drug combinations should allow for reductions in the dosages of the drugs used in a way that in particular in the case of toxic drugs such as those used for second stage HAT the toxicity of the combination does not exceed that of either monotherapy Of the three drug combinations nowadays possible melarsoprol-nifurtimox melarsoprol-eflornithine and eflornithine-nifurtimox the last one has in two different dosing regimens shown the least treatment-associated toxicity and mortality in the 69 patients treated in one previous and this clinical trial to date Good tolerability was also observed in a case series of 31 patients The efficacy data to date suggest that efficacy is comparable to that of eflornithine and that of melarsoprol in areas without high melarsoprol failure rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None