Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda

Phase 2/3 Terminated 31 enrolled Epicentre Médecins Sans Frontières, France · collab

NaSingle-groupOpen-label

Summary

This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.

Timeline

Start: 2002-10
Primary completion: —
Completion: —

Outcome

Outcome not reported

Stopped (Enrollment): “Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.”

Publications

Background Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three drug combinations for late-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39. doi: 10.1371/journal.pctr.0010039.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eflornithine	Small molecule	—	—
Subject	Nifurtimox	Small molecule	—	—