EFV/FTC/TDF switch to FTC/RPV/TAF in HIV-1 Patients

  • Research type

    Research Study

  • Full title

    A Phase 3b, Randomised, Double-Blind, Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenfovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

  • IRAS ID

    173451

  • Contact name

    Margaret Johnson

  • Contact email

    ottersriverbank@natsirt.co.uk

  • Sponsor organisation

    Gilead Sciences Europe Ltd.

  • Eudract number

    2014-004779-21

  • Clinicaltrials.gov Identifier

    123-098, IND Number

  • Duration of Study in the UK

    1 years, 5 months, 28 days

  • Research summary

    The treatment of HIV-1 infection requires prompt use of a combination of medicines after diagnosis to delay disease progression and prolong survival. The focus is now on drug regimens that prevent the development of drug resistance and also to patient adherence to the treatment. Adherence is improved by reducing the number of pills taken per day. It has been shown that once daily, single tablet regimens are associated with higher adherence to treatment, better clinical outcomes including fewer hospitalizations, improved patient satisfaction and excellent virological outcomes.

    The purpose of this study is to evaluate safety and to determine whether the study drug Emtricitabine/Rilpivirine/Tenofovir( F/R/TAF) works as well as Atripla. It is also to see if F/R/TAF will maintain the control of HIV-1 infection when compared to Atripla.

    Approximately 800 participants will take part at approximately 150 sites globally. Participation will last 48 weeks, not including the screening period which may last up to 30 days. Participants will be required to visit the clinic at least 7 times (day 1, weeks 4,8, 12, 24,36 and 48) After 48 weeks on treatment, they will continue to take the study drug and attend visits every 12 weeks until all participants have completed 48 weeks of treatment and the study is unblinded.

    Participants will be selected by chance to receive 1 of the following:
    Treatment Arm 1: Approximately 400 participants will receive F/R/TAF plus placebo to match EFV/FTC/TDF.
    Treatment Arm 2: Approximately 400 participants will receive will receive EFV/FTC/TDF plus placebo to match F/R/TAF.

    Neither the participant nor the study doctor will know what treatment was assigned.

  • REC name

    London - Bloomsbury Research Ethics Committee

  • REC reference

    15/LO/0496

  • Date of REC Opinion

    29 Apr 2015

  • REC opinion

    Further Information Favourable Opinion