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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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Epicentre:

Primary Outcome Measures:
  • Cure rate

Secondary Outcome Measures:
  • Adverse events temporally associated with the treatment
  • Major adverse events temporally associated with the treatment

Estimated Enrollment: 435
Study Start Date: March 2001
Estimated Study Completion Date: June 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330148

Locations
Uganda
Omugo Sleeping Sickness Treatment Center
Omugo, Arua District, Uganda
Sponsors and Collaborators
Epicentre
Medecins Sans Frontieres
Embassy of France in Uganda
National Sleeping Sickness Control Program, Uganda
Investigators
Principal Investigator: Gerardo Priotto, MD, MPH Epicentre
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00330148     History of Changes
Other Study ID Numbers: EPICENTRE-BTT
Study First Received: May 24, 2006
Last Updated: May 24, 2006
Health Authority: Uganda: Ministry of Health

Keywords provided by Epicentre:
trypanosomiasis
gambiense
combination drug therapy
sleeping sickness
Uganda

Additional relevant MeSH terms:
Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Eflornithine
Melarsoprol
Nifurtimox
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013