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

• Status: Terminated
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epicentre
• Collaborators: Embassy of France in Uganda; Medecins Sans Frontieres - French Section; Médecins Sans Frontières, France; National Sleeping Sickness Control Program, Uganda
• Treatments: Eflornithine; Melarsoprol; Nifurtimox

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