A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed (SWORD-2)

Trial Profile

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed (SWORD-2)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jan 2018

At a glance

  • Drugs Dolutegravir (Primary) ; Rilpivirine (Primary)
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SWORD-2
  • Sponsors ViiV Healthcare
  • Most Recent Events

    • 06 Jan 2018 Results of a pooled analysis of SWORD-1 and SWORD-2 (n=1028; Data cut-off: Nov 22, 2016) assessing the efficacy and safety of dolutegravir-rilpivirine published in The Lancet.
    • 21 Nov 2017 According to a Janssen Therapeutics media release, future long-term data and analyses will be presented at upcoming medical congresses.
    • 21 Nov 2017 According to a ViiV Healthcare media release, based on data from SWORD-1 and 2 US FDA has approved Juluca, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral (ART) regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
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