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Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00803933
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : December 8, 2008
Bill and Melinda Gates Foundation
Information provided by:
Immtech Pharmaceuticals, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
African Trypanosomiasis Drug: DB289 Drug: Pentamidine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Study Start Date : February 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : June 2005

Arm Intervention/treatment
Experimental: DB289
Pafuramidine maleate (DB289), 100 mg BID orally
Drug: DB289
Pafuramidine maleate (DB289), 100 mg BID orally
Other Name: pafuramidine maleate

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

Primary Outcome Measures :
  1. The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment. [ Time Frame: 3 months ]
  2. The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period. [ Time Frame: 12 day ]

Secondary Outcome Measures :
  1. The secondary outcome measure was the incidence rate of adverse events (all Grades combined) during the 7- to 9-day observation period in Treatment Sequence 1 and during the 12-day observation period in Treatment Sequence 2. [ Time Frame: 12 day ]
  2. The number and percentage of subjects with parasitological cure, subjects with confirmed (parasitological) treatment failure, and subjects with suspected treatment failure at 6, 12, and 24 months after completion of treatment. [ Time Frame: 6, 12, 24 months ]

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph node aspirate and greater than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
  2. Patient is 15 to 50 years old
  3. Patient has a minimal weight of 35 kilograms
  4. If the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy):

    1. she is not lactating,
    2. she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and
    3. she agrees to use a medically proven method of contraception (abstinence from sexual intercourse is an acceptable method) from the day of consent on until the end of the observation period (day 7).
  5. Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent

Exclusion Criteria:

  1. The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination or a WBC count of > 5mm-1
  2. Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders (A list of typical signs and symptoms is provided for guidance of the investigator in attachment 1)
  3. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
  4. Withdrawal of consent at any time during the study
  5. Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
  6. The subject has been previously treated for African Trypanosomiasis.
  7. The subject has been previously enrolled in the study. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803933

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CDTC Maluku
Gombe, Kinshasa, Congo
Vanga Hospital
Gombe, Kinshasa, Congo
Sponsors and Collaborators
Immtech Pharmaceuticals, Inc
Bill and Melinda Gates Foundation
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Principal Investigator: Victor Kande, MD Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian Burri, Study Director, Swiss Tropical Institute
ClinicalTrials.gov Identifier: NCT00803933    
Other Study ID Numbers: 289-C-006
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: December 2008
Keywords provided by Immtech Pharmaceuticals, Inc:
first stage
Trypanosoma brucei gambiense
T. b. gambiense
sleeping sickness
First stage T. b. gambiense sleeping sickness
Additional relevant MeSH terms:
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Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Trypanocidal Agents