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)

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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