The Penta-sponsored clinical trial SMILE has achieved a significant milestone by recruiting its 100th patient yesterday. The patient was enrolled at the Perinatal HIV Research Unit (PHRU) in Soweto, South Africa. This is a wonderful result achieved through hard work and cooperation among the sites, the CTUs 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” and 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. 300 children are due to be enrolled in the trial from about 30 sites spread across 14 countries in Europe, Asia, Africa and South America.
With one third of the patients enrolled and several new sites starting recruitment this month, the SMILE clinical trial is successfully reaching its goals and expected enrollment targets. We extend our congratulations and thanks to all teams involved for your ongoing collaboration!
The trial is supported by Janssen Pharmaceutica and ViiV Healthcare.