Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
Acoziborole as an oral, single-dose treatment was studied in an open-label pivotal Phase
II/III trial (DNDi-OXA-02-HAT) in DRC and Guinea. The safety and efficacy results on g-HAT
confirmed cases (all disease stages) from the pivotal study provided data, that allows to
envision the treatment of confirmed g-HAT cases but there is still a gap in the management of
g-HAT seropositive non-parasitologically confirmed individuals. Indeed, the standard g-HAT
case definition implies the demonstration of the parasite in any body fluid via microscopy.
However, there are factors such as low parasitaemia and the complexity and low sensitivity of
parasitological methods that make such demonstration difficult. It has been demonstrated that
a variable proportion (mainly depending on the prevalence) of such g-HAT "sero-suspects" are
confirmed cases and, therefore, remaining as potential reservoirs of the parasite and a
source of new infections hindering the efforts to eliminate the disease.
The present clinical trial intends to expand the safety data of acoziborole and complement
the safety profile obtained from the pivotal trial by assessing the safety and tolerability
of a single dose of acoziborole compared with placebo in seropositive individuals who are not
confirmed parasitologically.
In addition to this study, an exploratory sub-study named 'TrypSkin' is planned to assess the
presence of extravascular dermal T.b. gambiense in the population enrolled.