Status:
COMPLETED
A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Lead Sponsor:
Immtech Pharmaceuticals, Inc
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Trypanosomiasis, African
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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. Treatm...
Detailed Description
This is a single-center, open label, non-controlled Phase IIa trial. Patients with first stage T.b. gambiense sleeping sickness will receive 100 mg of DB289 orally twice a day for 5 days. Subjects mee...
Eligibility Criteria
Inclusion
- The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph and less than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
- Patient is 16 years old or more
- Patient has a minimal weight of 45 kilograms
- If 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 acceptable) from the day of consent on until 7 Days after DB289 treatment completion (Study Day 12).
- Patient has signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent
Exclusion
- The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination, or a positive (titer greater than 1/4) latex / IgM test, or a positive latex / T.b.g.
- 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 or significant ECG anomaly such as elongated QTc (corrected) interval above 430 msec for men or above 450 msec for women, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders.
- Clinically significant abnormal laboratory value at screening including:
- Prothrombin Time \> 1.25 times upper limit of normal (ULN)
- Liver enzyme AST and ALT \> 2 times ULN
- Total bilirubin \> 1.5 times ULN
- Serum Creatinine \> 1.5 times ULN
- Traumatic lumbar puncture (i.e. red blood cells visible in CSF)
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00802594
Start Date
August 1 2001
End Date
November 1 2004
Last Update
December 5 2008
Active Locations (2)
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1
Laboratory of Reference and Investigation, Viana, ICCT
Bairro Ingombota, Luanda Province, Angola, CP 2657-C
2
Programme National de Lutte contre la Trypanosomiase
Kinshasa, Gombe, Republic of the Congo