We are thrilled to bring you the news that the Penta-sponsored clinical trial, SMILE, has hit its enrolment target with the recruitment of its 300th patient. The patient was enrolled at the Kryvyi Rih Hospital in Ukraine. This wonderful result has been achieved through the continued hard work, commitment and cooperation among the sites, the clinical trial units and the sponsor.
SMILE (also known as PENTA 17) stands for “Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor + darunavir/ritonavir in childrEn”. It is a multicentre randomised study evaluating safety and antiviral effect of a once daily integrase inhibitor administered with darunavir/ritonavir compared to standard of care among HIV-1 infected, virologically suppressed paediatric participants. Participants from 32 sites spread across 11 countries in Europe, Asia, Africa and South America have taken part in the study. All participants will be followed up for a minimum of 48 weeks until the last participant enrolled reaches 48 weeks of follow-up.
Our congratulations and thanks to the participants and families, the clinicians and sites involved as well as the clinical trial units of the study, INSERM-SC10, MRC-CTU at UCL and PHPT for your ongoing collaboration! We also extend a very special thank you to the Chief Investigator of the trial, Prof. José Tomas Ramos Amador and the Clinical Project Officer, Dr. Alexandra Compagnucci and and her team.
The trial is supported by Janssen Pharmaceutica and ViiV Healthcare. The IMPs Prezista (DRV) and Tivicay (DTG) are provided by the companies respectively.