NCT00330148

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

Terminated Phase 3 Last updated 24 May 2006

What this trial tests

Phase 3 trial testing melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d in Trypanosomiasis, African in 435 participants. Terminated before completion.

Timeline

1 March 2001

1 June 2004

Quick facts

Lead sponsor	Epicentre
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	435
Start date	1 March 2001
Estimated completion	1 June 2004
Sites	1 location across Uganda

Drugs / interventions tested

• melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d — full drug profile →
• melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d — full drug profile →
• nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d — full drug profile →

Conditions studied

• Trypanosomiasis, African — all drugs for Trypanosomiasis, African →

Sponsor

Epicentre — full company profile →

Who can join

0 and older, any sex, with Trypanosomiasis, African. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cure rate

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Three drug combinations for late-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Uganda.
   Priotto G, Fogg C, Balasegaram M, Erphas O, et al · · 2006 · cited 67× · PMID 17160135 · DOI 10.1371/journal.pctr.0010039
2. Nifurtimox plus Eflornithine for late-stage sleeping sickness in Uganda: a case series.
   Checchi F, Piola P, Ayikoru H, Thomas F, et al · · 2007 · cited 48× · PMID 18060083 · DOI 10.1371/journal.pntd.0000064