NCT00330148

Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 435 (planned)
• Sponsor: Epicentre · Academic / Other
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Trypanosomiasis, African

Interventions

Type	Name	Description
DRUG	melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d
DRUG	melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d
DRUG	nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d

Timeline

• Start date: 2001-03-01
• Completion: 2004-06-01
• First posted: 2006-05-26
• Last updated: 2006-05-26

Locations

1 site across 1 country: Uganda