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A Phase 3b, Randomized, Open-label Study of the Antiviral Activity and Safety of Dolutegravir Compared to Lopinavir/Ritonavir Both Administered With Dual Nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1 Infected Adult Subjects With Treatment Failure on First Line Therapy

Trial Profile

A Phase 3b, Randomized, Open-label Study of the Antiviral Activity and Safety of Dolutegravir Compared to Lopinavir/Ritonavir Both Administered With Dual Nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1 Infected Adult Subjects With Treatment Failure on First Line Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2019

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At a glance

  • Drugs Dolutegravir (Primary) ; Lopinavir/ritonavir; Nucleoside reverse transcriptase inhibitors
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms DAWNING
  • Sponsors ViiV Healthcare
  • Most Recent Events

    • 07 Mar 2019 Primary endpoint has been met. (Proportion of subjects with plasma HIV-1 Ribonucleic acid (RNA) 50 copies/millilitre (c/mL) using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure) for the ITT-E population)
    • 07 Mar 2019 Results presented at the 26th Conference on Retroviruses and Opportunistic Infections
    • 31 Oct 2018 Results of the patient-reported outcome (PRO) measures, from this study were presented at the 14th International Congress on Drug Therapy and HIV Infection.
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