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An Open-label, Randomized, Two-way Crossover, Single Dose, Pivotal Bioequivalence Study of a Fixed-dose Combination of Dolutegravir and Rilpivirine in Healthy Volunteers

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Trial Profile

An Open-label, Randomized, Two-way Crossover, Single Dose, Pivotal Bioequivalence Study of a Fixed-dose Combination of Dolutegravir and Rilpivirine in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jun 2023

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At a glance

  • Drugs Dolutegravir/rilpivirine (Primary) ; Dolutegravir; Rilpivirine
  • Indications HIV infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors ViiV Healthcare

    • Most Recent Events

    • 09 Jul 2018 Results published in the Antimicrobial Agents and Chemotherapy
    • 23 Mar 2018 The European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure. The application was supported by SWORD-1 and SWORD-2, and a pivotal bioequivalence study.
    • 25 Oct 2016 Status changed from recruiting to completed.
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