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

Phase 3

Terminated

• Conditions: Trypanosomiasis, African

• Registration Number: NCT00330148
• Lead Sponsor: Epicentre

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.

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.

Study Timeline

• Study Start: 2001-03
• Study Completion: 2004-06
• Status Verified: 2006-05
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Last Update Submitted: 2006-05-24
• Study First Posted: 2006-05-26
• Last Update Posted: 2006-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 435

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cure rate

Secondary Outcome Measures

Name	Time	Method
Adverse events temporally associated with the treatment
Major adverse events temporally associated with the treatment

Trial Locations

Locations (1)

Omugo Sleeping Sickness Treatment Center; 🇺🇬 Omugo, Arua District, Uganda