Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
Status:
Terminated
Trial end date:
2004-06-01
Target enrollment:
Participant gender:
Summary
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.