FTC/RPV/TAF switch from FTC/RPV/TDF in HIV-1 positive

• Research type

  Research Study

• Full title

  A Phase 3b, Randomised, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

• IRAS ID

  173450

• Contact name

  Margaret Johnson

• Contact email

  ottersriverbank@natsirt.co.uk

• Sponsor organisation

  Gilead Sciences Europe

• Eudract number

  2014-004545-27

• Clinicaltrials.gov Identifier

  123098, 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 sponsored by Gilead Sciences is to evaluate safety and to determine whether the study drug Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) works as well as Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (Eviplera). It is also to see if F/R/TAF will maintain the control of HIV-1 infection when compared to Eviplera.

  Approximately 550 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 275 participants will receive F/R/TAF plus placebo to match F/R/TDF
  Treatment Arm 2: Approximately 275 participants will receive will receive F/R/TDF plus placebo to match F/R/TAF

  Neither the participant or the study doctor will know what treatment was assigned.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  15/LO/0495

• Date of REC Opinion

  29 Apr 2015

• REC opinion

  Further Information Favourable Opinion