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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 19 Dec 2023

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At a glance

  • Drugs Darunavir (Primary) ; Dolutegravir (Primary) ; Ritonavir (Primary) ; Antiretrovirals; Nucleoside reverse transcriptase inhibitors
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Acronyms PENTA 17 - SMILE; SMILE; SMILE (PENTA 17)
  • Most Recent Events

    • 11 Dec 2023 Results from PK substudy, assessing pharmacokinetics of DRV in the younger population and the importance of the RTV boosting effect, published in the Antimicrobial Agents and Chemotherapy
    • 30 Sep 2020 Status changed from active, no longer recruiting to completed.
    • 04 Mar 2020 This trial has been completed in Germany, according to European Clinical Trials Database.
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