SMILE: Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor+darunavir/ritonavir in childrEn (PENTA 17) - A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.
Phase of Trial: Phase II/III
Latest Information Update: 02 Feb 2018
At a glance
- Drugs Elvitegravir (Primary) ; Darunavir; Ritonavir
- Indications HIV-1 infections
- Focus Therapeutic Use
- Acronyms PENTA 17 - SMILE; SMILE (PENTA 17)
- 23 Jun 2017 This trial has been suspended in Germany as per European Clinical Trials Database record
- 10 Jun 2017 Biomarkers information updated
- 11 Feb 2017 This trial has been suspended in Spain as per European Clinical Trials Database record.