Alexandra Compagnucci, Man K Chan, Yacine Saïdi, Tim R Cressey, Alasdair Bamford, Yoann Riault, Alexandra Coelho, Aoife Nolan, Suwalai Chalermpantmetagul, Gabija Morkunaite, Pauline Amuge, Victor Musiime, Avy Violari, Mark Cotton, Adeodata R Kekitiinwa, Elizabeth Kaudha, Marisa Groenewald, Afaaf A Liberty, Suparat Kanjanavanit, Alla Volokha, Rosa Bologna, Noris Pavia Ruz, Luis Prieto Tato, Paolo Paioni, Laura Marques, Véronique Reliquet, Tim Niehues, Steven B Welch, Deborah Ford, Carlo Giaquinto, Diana M Gibb, Abdel Babiker, Jose Tomas Ramos Amador
BACKGROUND: Integrase inhibitor (INSTI) with boosted darunavir (DRV/r), a regimen with a high-resistance barrier, avoiding NRTI toxicities, might be a switching option in children living with HIV (CLWHIV). METHODS: SMILE is a randomised non-inferiority trial evaluating safety and antiviral efficacy of once-daily INSTI + DRV/r vs. continuing on current standard-of-care (SOC) triple ART (2NRTI + boosted PI/NNRTI) in virologically-suppressed CLWHIV aged 6-18 years...
June 2023: EClinicalMedicine