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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00330148
• Date of registration: 24/05/2006
• Prospective Registration: No
• Primary sponsor: Epicentre
• Public title: Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
• Scientific 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
• Date of first enrolment: March 2001
• Target sample size: 435
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00330148
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Uganda

Contacts

• Name: Gerardo Priotto, MD, MPH
• Affiliation: Epicentre

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Trypanosomiasis, African

Intervention(s)

Drug: melarsoprol 1.8 mg/kg/d, 10d + nifurtimox 15/20 mg/kg/d, 10d

Drug: nifurtimox 15/20 mg/kg/d 10d + eflornithine 400 mg/kg/d 7d

Drug: melarsoprol 1.8 mg/kg/d, 10d + eflornithine 400 mg/kg/d, 7d

Primary Outcome(s)

Cure rate

Secondary Outcome(s)

Adverse events temporally associated with the treatment

Major adverse events temporally associated with the treatment

Secondary ID(s)

EPICENTRE-BTT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Sleeping Sickness Control Program, Uganda

Embassy of France in Uganda

Medecins Sans Frontieres