The Kenya site has already recruited 400 participants, and the sites in Ethiopia and Mozambique are finishing preparations to initiate recruitment
One of the schools participating in the trial (Ethiopia). photo: Nuria Cortes
The ALIVE phase 2 trial conducted in Kwale County (Kenya), with the aim to test the safety of a fixed dose combination of ivermectin and albendazole, was successfully completed in March 2022.
Now, the STOP team has started phase 3 of the trial, which will be performed in three sites (Kenya, Ethiopia and Mozambique), with a total of 1097 school children treated. Kenya has already recruited almost 400 participants, of which all have completed the trial procedure. Ethiopia and Mozambique are in the last mile of the trial set-up, waiting for the final regulatory clearance and for the drug to be imported, and will soon initiate recruitment activities.
“We are planning to perform an interim analysis of the trial results by the last quarter of 2022 and we hope to share some of the early findings during the next annual meeting of the consortium,” explains Alejandro Krolewiecki, who is leading the clinical trial.
The ALIVE trial aims to test the safety and efficacy of combining a fixed dose of ivermectin and albendazole in one single pill, compared to the current treatment (albendazole alone), for the treatment of intestinal worms (soil-transmitted helminths). If successful, this new combination would represent an important tool for programmes aimed at interrupting transmission of STH, and would also help prevent the emergence of drug-resistant worms.