SSAT067 PK of atazanavir/cobicistat and darunavir/cobicistat

  • Research type

    Research Study

  • Full title

    Pharmacokinetics of atazanavir/cobicistat and darunavir/cobicistat once daily over 72 hours following drug intake cessation in healthy volunteers

  • IRAS ID

    184771

  • Contact name

    Marta Boffito

  • Contact email

    Marta.Boffito@chelwest.nhs.uk

  • Sponsor organisation

    St Stephens AIDS Trust

  • Eudract number

    2015-002956-28

  • Duration of Study in the UK

    0 years, 5 months, 10 days

  • Research summary

    The purpose of this study is to look at the levels of three HIV medications: atazanavir, darunavir and cobicistat in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 10 days. Participants will take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and cobicistat) on a second stage.
    If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication.
    This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications the participant is taking at all times during the study.

  • REC name

    London - Bloomsbury Research Ethics Committee

  • REC reference

    15/LO/1596

  • Date of REC Opinion

    19 Oct 2015

  • REC opinion

    Further Information Favourable Opinion