SSAT 047: Efavirenz to Rilpivirine FDC Switch Study

• Research type

  Research Study

• Full title

  A phase III, open-label, multi centre pilot study to assess the feasibility of switching, individuals receiving Atripla or Kivexa plus Efavarinz with continuing Central Nervous System (CNS) toxicity, to a fixed dose combination of tenofovir/emtricitabine/rilpivirine (Eviplera)

• IRAS ID

  110517

• Contact name

  Mark Nelson

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2012-002205-22

• ISRCTN Number

  N/A

• Research summary

  This is a phase III, open-label (ie all subjects know what medications they are taking), multi-centre trial taking in place at 4 sites in the UK. The purpose of the study is to investigate the benefits of switching away from efavirenz (which is taken in combination with Kivexa© or as part of the combination pill, Atripla©) in patients with central nervous system side effects (such as insomnia difficulty with sleeping, bad dreams etc). We will investigate the effect of switching to a single tablet regimen (Eviplera©) containing tenofovir, emtricitabine and rilpivirine. If the subject is currently taking Atripla, rilpivirine will be the only new component of the combination. Rilpivirine is a drug for HIV treatment, licensed for first-line treatment. In combination with Truvada©, it showed fewer side effects when compared to efavirenz in 2 other clinical studies, where patients were starting HIV treatment for the first time. This study will also investigate the safety (in terms of other side effects and the routine blood tests which are ordinarily used to monitor patients' treatment) and monitor effectiveness, patients' viral loads and CD4 counts when patients switch treatment to tenofovir/emtricitabine/rilpivirine.

• REC name

  London - South East Research Ethics Committee

• REC reference

  12/LO/1211

• Date of REC Opinion

  2 Oct 2012

• REC opinion

  Further Information Favourable Opinion