STROgHAT
An Intervention Study to Evaluate the Impact of Treating gHAT Seropositives Subjects With Acoziborole on Transmission of T.b. Gambiense, and Obtain Further Safety Data on Acoziborole in gHAT Seropositives Individuals.
Sponsor study identifier
interventional
2,500
1 country
1
Study Start
March 15, 2024
Actual (reported)Primary Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. We 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, we 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2024
Actual (reported)August 4, 2026
Actual (reported)August 27, 2026
Actual (reported)December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
interruption of transmission of T.b. gambiense
\- 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. The number of parasitologically negative seropositive gHAT suspects is reduced to zero or near zero within the timeframe of the project
4 years
Assessment of Safety
To assess the safety of acoziborole in gHAT seropositive individuals and parasitologically-negative by measuring the proportion of participants who present related treatment emergent severe adverse events. Mild, moderate and severe related ermergent adverse events will be measured.
3 year
economic evaluation
4 years
assessment of the performance of several diagnostic tests
4 years
The investigational product (IP) is: * acoziborole three 320-mg tablets (960 mg dose), administered by the oral route to adolescent and adults ≥15 years as single dosing regimen on Day 1 of the study in fed or fasting state * acoziborole two 320-mg tablets (640 mg dose), administered by the oral route to children 11-14 years (and ≥30kg) as single dosing regimen on Day 1 of the study in fed or fasting state No active comparative treatment will be used in this study Doses and treatment regimens * Adolescent and adults ≥15 years: 960 mg (3x320mg) oral unique dose in fed or fasting state * Children 11-14 years (and ≥30kg): 640 mg (2x320mg) oral unique dose in fed or fasting state
treatment of seropositive individuals (positive serology test, but parasitology not confirmed). Subjects agreeing to participate study and matching the inclusion/exclusion criteria will receive acoziborole 960 or 640 mg in a single intake at study day 1. Following treatment, participants will attend follow-up visits at home or at the study centre at 3 days and 3-months post-treatment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Coordination Provincial de Lutte contre la THA
Bwamanda, Democratic Republic of the Congo
Elena Nicco
Insitute of Tropical Medicine
First Submitted
August 4, 2026
First Posted
August 27, 2026
Study Start
March 15, 2024
Actual (reported)Primary Completion
December 30, 2026
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 27, 2026
Record last verified: 2026-08
anonymity of participants must be guaranteed, GDRPR rules will apply anonymised study results can be shared with other researchers upon request
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Source: ClinicalTrials.gov.
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