A Phase 3 interventional study of melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d and melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d in Trypanosomiasis, African, sponsored by Epicentre. Terminated at 1 site in Uganda. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2006-05-26.
Sponsored by Epicentre · Phase 3, Interventional, and Treatment
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970's in series of cases of HAT, is at present the only other available alternative.
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.
This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.
Dosages per drug are the same in either arm of the study: IV melarsoprol 1.8 mg/kg/day, daily for 10 days; IV eflornithine 400 mg/kg/day, 6-hourly for 7 days; oral nifurtimox 15 or 20 (children \<15 years) mg/kg/day, 8-hourly for 10 days.
For efficacy assessment, patients are followed-up for 24 months after treatment, with planned clinical and laboratory controls.
The safety assessment includes clinical and hematological adverse events.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 435 is above the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.
Browse Trypanosomiasis, African studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
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confirmed second-stage T.b. gambiense infection :
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Cure rate
Adverse events temporally associated with the treatment
Major adverse events temporally associated with the treatment
This study is terminated, as verified in May 2006. You cannot join it, but the record below documents what was studied.
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