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: 08 Jun 2017

At a glance

  • Drugs Dolutegravir (Primary) ; Rilpivirine (Primary) ; Non-nucleoside reverse transcriptase inhibitors; Nucleoside reverse transcriptase inhibitors; Peptide hydrolase inhibitors
  • Indications HIV-1 infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms SWORD-2
  • Sponsors ViiV Healthcare
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 01 Jun 2017 According to a ViiV Healthcare media release, a recently acquired priority review voucher was submitted to the FDA along with the dolutegravir and rilpivirine 2-drug regimen New Drug Application (NDA). Under the Prescription Drug User Fee Act, the anticipated target action date is six months after receipt of the application by the FDA.
    • 01 Jun 2017 According to a Janssen media release, ViiV Healthcare has made regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen). The submissions were based on the SWORD studies.
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