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Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

NCT00803933 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2008-12-08

No results posted yet for this study

Summary

Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control.

This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.

Conditions

  • African Trypanosomiasis

Interventions

DRUG

DB289

Pafuramidine maleate (DB289), 100 mg BID orally

DRUG

Pentamidine

Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Immtech Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Victor Kande, MD · Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2004-02-29
Completion
2005-06-30

Countries

  • Republic of the Congo

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 NCT00803933 on ClinicalTrials.gov