SMILE Trial Launch – investigating a potentially lower toxicity, simplified treatment regimen for HIV infected children

26 Jul 2016

The SMILE trial - testing a new combination of drugs for children with HIV – is now open to recruitment.

The aim of the trial is to evaluate the safety and effectiveness of elvitegravir administered with ritonavir boosted darunavir compared to current standard antiretroviral therapy in children with HIV who are already on effective treatment. This novel strategy reduces the number of classes of antiretroviral drugs used in combination from 3 to 2 which can potentially limit drug related toxicity.

HIV is a global health issue. In 2014, around 1.2 million people died from HIV-related causes globally. At the end of 2013, an estimated 3.2 million children were living with HIV, most in sub-Saharan Africa and the majority acquiring HIV from their mothers during pregnancy, birth or breastfeeding. 

The team looks to recruit 300 HIV infected children aged 6 to less than 18 years of age who are already on effective treatment, at sites across Western and Eastern Europe, South Africa, Thailand, Uganda and Latin America. 

The trial will be run in partnership with Inserm-ANRS in France, MRC CTU at UCL and PHPT in Thailand and is sponsored by the PENTA Foundation, and funded by the PENTA Foundation, Gilead and Janssen The study is led by Chief Investigator Professor Jose Tomas Ramos Amador at Hospital Clinico San Carlos Madrid, Spain.

Further information: