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Completed

NCT Number: NCT00803933

Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

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.

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Key information

Conditions

African Trypanosomiasis Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Trypanosomiasis, African Vector Borne Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CDTC Maluku, Gombé, Kinshasa, Republic of the Congo

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patient is 15 to 50 years old
  • Patient has a minimal weight of 35 kilograms
  • 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):
  • she is not lactating,
  • she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and
  • 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).
  • Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent

Exclusion criteria

  • 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
  • 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)
  • Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
  • Withdrawal of consent at any time during the study
  • Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
  • The subject has been previously treated for African Trypanosomiasis.
  • The subject has been previously enrolled in the study. -

Treatment and study plan

DB289

Drug

Pafuramidine maleate (DB289), 100 mg BID orally

Other names: pafuramidine maleate

Pentamidine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Immtech Pharmaceuticals, Inc

Industry

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Dec 8, 2008
Registry last updated
Dec 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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