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

NCT00330148 | Terminated Phase 3

• 1 other identifier: EPICENTRE-BTT
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Trypanosomiasis, African

Keywords

trypanosomiasis; gambiense; combination drug therapy; sleeping sickness; Uganda

Outcome Measures

Primary Outcomes (1)

• Cure rate

Secondary Outcomes (2)

• Adverse events temporally associated with the treatment

• Major adverse events temporally associated with the treatment

Interventions

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 DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Trypanosome absent from blood (or lymph node fluid) and from CSF
• 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

Sponsors & Collaborators

• Epicentre: lead
• Médecins Sans Frontières, France: collaborator
• Embassy of France in Uganda: collaborator
• National Sleeping Sickness Control Program, Uganda: collaborator

Study Sites (1)

Omugo Sleeping Sickness Treatment Center

Omugo, Arua District, Uganda

Location

Related Publications (1)

• Legros D, Ollivier G, Gastellu-Etchegorry M, Paquet C, Burri C, Jannin J, Buscher P. Treatment of human African trypanosomiasis--present situation and needs for research and development. Lancet Infect Dis. 2002 Jul;2(7):437-40. doi: 10.1016/s1473-3099(02)00321-3.

  PMID: 12127356 BACKGROUND

MeSH Terms

Conditions

Trypanosomiasis, African; Trypanosomiasis

Interventions

Melarsoprol; Nifurtimox; Eflornithine

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Organic Chemicals; Nitrofurans; Nitro Compounds; Thiazines; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Gerardo Priotto, MD, MPH

  Epicentre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 26, 2006
• Study Start: March 1, 2001
• Study Completion: June 1, 2004
• Last Updated: May 26, 2006

Record last verified: 2006-05

Locations

UG (1)