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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2017

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

    • 26 Jul 2017 According to an interim results (poster) presented at the 9th International AIDS Society Conference on HIV Science, the study protocol has been amended to allow ongoing lopinavir/ritonavir subjects to switch to the dolutegravir arm as per the recommendation of an independent data monitoring committee.
    • 26 Jul 2017 According to an interim results presented at the 9th International AIDS Society Conference on HIV Science, an independent data monitoring committee (IDMC) performed periodic review of 24 weeks data, and large subsets of data from weeks 36 and 48 and recommended discontinuation of the LPV/RTV arm due to persistent differences in rates of Snapshot virologic non-response and protocol-defined virologic failure (PDVF) favouring the DTG arm.
    • 26 Jul 2017 Interim results presented at the 9th International AIDS Society Conference on HIV Science.
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