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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330148
Recruitment Status : Terminated
First Posted : May 26, 2006
Last Update Posted : May 26, 2006
Médecins Sans Frontières, France
Embassy of France in Uganda
National Sleeping Sickness Control Program, Uganda
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Brief 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.

Condition or disease Intervention/treatment Phase
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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2001
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cure rate

Secondary Outcome Measures :
  1. Adverse events temporally associated with the treatment
  2. Major adverse events temporally associated with the treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00330148

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Omugo Sleeping Sickness Treatment Center
Omugo, Arua District, Uganda
Sponsors and Collaborators
Médecins Sans Frontières, France
Embassy of France in Uganda
National Sleeping Sickness Control Program, Uganda
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Principal Investigator: Gerardo Priotto, MD, MPH Epicentre
Layout table for additonal information Identifier: NCT00330148    
Other Study ID Numbers: EPICENTRE-BTT
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: May 26, 2006
Last Verified: May 2006
Keywords provided by Epicentre:
combination drug therapy
sleeping sickness
Additional relevant MeSH terms:
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Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action