A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

NCT ID: NCT00802594

Last Updated: 2008-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2004-11-30

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 which might be used as a tool to support disease control that is easily administered and has low toxicity.

This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of more than a dozen partners from academia, industry, and the Ministries of Health of Angola and the Democratic Republic of Congo.

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 meeting entry criteria will be enrolled at a single site.

A total of 30 patients will be enrolled in this trial. Enrollment is planned to begin third quarter 2001 and be completed in 2-3 months.

The study will be conducted at the Trypanosomiasis Reference Center, Viana (ICCT), Angola, and at the Trypanosomiasis Treatment Center in Maluku, Congo.

Conditions

Trypanosomiasis, African

Keywords

first stage; T.b. gambiense; sleeping sickness; Patients with first stage T.b. gambiense sleeping sickness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DB289

Group Type: EXPERIMENTAL

DB289

Intervention Type: DRUG

A single 100 mg DB289 capsule will be taken by mouth twice a day, morning and evening. Drug is to be taken with a glass of water within 15 minutes of the completion of meal.

Interventions

DB289

A single 100 mg DB289 capsule will be taken by mouth twice a day, morning and evening. Drug is to be taken with a glass of water within 15 minutes of the completion of meal.

Intervention Type: DRUG

Other Intervention Names

pafuramidine maleate

Eligibility Criteria

Inclusion Criteria

1. 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

2. Patient is 16 years old or more

3. Patient has a minimal weight of 45 kilograms

4. 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).

5. Patient has 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 positive (titer greater than 1/4) latex / IgM test, or a positive latex / T.b.g.

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 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.

3. 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

4. Traumatic lumbar puncture (i.e. red blood cells visible in CSF)

5. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)

6. Withdrawal of consent at any time during the study

7. Any condition which compromises ability to communicate with the investigator as required for the completion of this study.

8. The subject has been previously treated for African Trypanosomiasis.

9. The subject has been previously enrolled in the study.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Immtech Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Swiss Tropical Institute

Principal Investigators

Christian Burri, MSc, PhD

Role: STUDY_DIRECTOR

Swiss Tropical & Public Health Institute

Locations

Laboratory of Reference and Investigation, Viana, ICCT

Bairro Ingombota, Luanda Province, Angola

Programme National de Lutte contre la Trypanosomiase

Kinshasa, Gombe, Republic of the Congo

Countries

Angola; Republic of the Congo

References

Burri C, Yeramian PD, Allen JL, Merolle A, Serge KK, Mpanya A, Lutumba P, Mesu VK, Bilenge CM, Lubaki JP, Mpoto AM, Thompson M, Munungu BF, Manuel F, Josenando T, Bernhard SC, Olson CA, Blum J, Tidwell RR, Pohlig G. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies. PLoS Negl Trop Dis. 2016 Feb 16;10(2):e0004362. doi: 10.1371/journal.pntd.0004362. eCollection 2016 Feb.

Reference Type: DERIVED

PMID: 26881924 (View on PubMed)

Other Identifiers

289-C-003

Identifier Type: -

Identifier Source: org_study_id