An Intervention Study to Evaluate the Impact of Treating gHAT Seropositive Subjects With Acoziborole on Transmission of T.b. Gambiense, and Obtain Further Safety Data on Acoziborole in gHAT Seropositive Individuals

STROgHAT

This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study. The investigators hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, that it will be able to arrive at a zero prevalence over a three-year period. The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative.

2024-04-08

2026-12-30

2027-12-30

Not yet recruiting

Early phase I

2500

Inclusion Criteria: * • Participants able to give signed informed consent and assent form for adolescents, which includes willingness to comply with the schedule of follow-up visits and other requirements and restrictions listed in the informed consent form (ICF) and in this protocol * All sexes * 11 years of age or older at the start of the study and weight ≥30 kg at the screening of Part B * Participants who are CATT test or HAT RDT positive (information provided by the mobile team and included into TrypElim (see Part A) * Participants who are able to ingest oral tablets * Participants with known address and/or contact details provided * Participants who are able to comply with the schedule of follow-up visits and other requirements of the study * Participants must agree not take part in any other clinical trials during the participation in part B of this study * Participants of child-bearing potential must be willing to use appropriate contraceptive methods. Exclusion Criteria: * • Individuals with a positive parasitological exam on the spot at baseline (mAECT or lymph gland puncture) * Participants previously treated for g-HAT or previously treated because of gHAT seropositive results * Pregnant women * Breast-feeding women * Children ≥11 years, but under 30kg body weight at the screening for part B * Clinically significant medical condition that could, in the opinion of the investigator, jeopardise the subject's safety or participation in the study * Individuals presenting a jaundice at screening * Participants who are taking, or who are expected to need to start within 3 months, a medicine (including traditional or herbal) which may interact with acoziborole and which cannot be stopped or adjusted (please refer to investigator manual or contact DNDi)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'one-arm, open label, non-randomized, multicentre, phase IIIb study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2500, 'type': 'ESTIMATED'}}

2024-04-10