Trypanosomiasis, African Clinical Trial
Official title:
Clinical Trial Comparing the Therapeutic Combinations Melarsoprol-Nifurtimox, Melarsoprol-Eflornithine and Eflornithine-Nifurtimox in the Treatment of Gambiense Human African Trypanosomiasis in the Meningo-Encephalitic Phase
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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