Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

NCT ID: NCT00803933

Last Updated: 2008-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-06-30

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 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

Keywords

first stage; Trypanosoma brucei gambiense; T. b. gambiense; sleeping sickness; First stage T. b. gambiense sleeping sickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DB289

Pafuramidine maleate (DB289), 100 mg BID orally

Group Type: EXPERIMENTAL

DB289

Intervention Type: DRUG

Pafuramidine maleate (DB289), 100 mg BID orally

Pentamidine

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

Group Type: ACTIVE_COMPARATOR

Pentamidine

Intervention Type: DRUG

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

Interventions

DB289

Pafuramidine maleate (DB289), 100 mg BID orally

Intervention Type: DRUG

Pentamidine

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

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 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. -

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 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

Victor Kande, MD

Role: PRINCIPAL_INVESTIGATOR

Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine

Locations

CDTC Maluku

Gombé, Kinshasa, Republic of the Congo

Vanga Hospital

Gombé, Kinshasa, Republic of the Congo

Countries

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-006

Identifier Type: -

Identifier Source: org_study_id