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

This study has been terminated.
Sponsor:
Collaborators:
Medecins Sans Frontieres
Embassy of France in Uganda
National Sleeping Sickness Control Program, Uganda
Information provided by:
Epicentre
ClinicalTrials.gov Identifier:
NCT00330148
First received: May 24, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted

May 24, 2006
May 24, 2006
March 2001
Not Provided
Cure rate
Same as current
No Changes Posted
  • Adverse events temporally associated with the treatment
  • Major adverse events temporally associated with the treatment
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Trypanosomiasis, African
  • 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
Not Provided
Legros D, Ollivier G, Gastellu-Etchegorry M, Paquet C, Burri C, Jannin J, Buscher P. Treatment of human African trypanosomiasis--present situation and needs for research and development. Lancet Infect Dis. 2002 Jul;2(7):437-40. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
435
June 2004
Not Provided

Inclusion Criteria:

  • confirmed second-stage T.b. gambiense infection :

    • Infection diagnosed parasitologically (blood or lymph node fluid) and white blood cells > 5/mm3 in cerebrospinal fluid (CSF)
    • or Trypanosomes detected in the CSF with any CSF cell count
  • and resident in the district
  • and written consent of the patient or of one of the parents/guardians for children under 15 years of age.

Exclusion Criteria:

  • Trypanosome absent from blood (or lymph node fluid) and from CSF
  • Or women pregnant on inclusion
  • Or previous history of HAT confirmed treated during the last 24 months
  • Or impossibility of regular access to the treatment centre during the 2 years following the end of the treatment
  • Or less than 10 kg of body weight
  • Or refugee patient
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00330148
EPICENTRE-BTT
Not Provided
Not Provided
Epicentre
  • Medecins Sans Frontieres
  • Embassy of France in Uganda
  • National Sleeping Sickness Control Program, Uganda
Principal Investigator: Gerardo Priotto, MD, MPH Epicentre
Epicentre
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP