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

NCT00330148 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2006-05-26

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Médecins Sans Frontières, France

    collaborator OTHER

  • Embassy of France in Uganda

    collaborator UNKNOWN

  • National Sleeping Sickness Control Program, Uganda

    collaborator UNKNOWN

  • Epicentre

    lead OTHER

Principal Investigators

  • Gerardo Priotto, MD, MPH · Epicentre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Completion
2004-06-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00330148 on ClinicalTrials.gov