Trypanosomiasis, African Clinical Trial
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
The purpose of this study is to compare the therapeutic combination of I.V. 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.
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 1970's 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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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