SSAT058:Atripla to Eviplera switch in patients without CNS symptoms

• Research type

  Research Study

• Full title

  SSAT058: A phase IV, open-label, multi centre pilot study to assess changes in cerebral function parameters in patients without perceived Central Nervous System (CNS) symptoms when switched from tenofovir/emtricitabine/efavirenz (Atripla®) to a fixed dose combination of tenofovir/emtricitabine/rilpivirine (Eviplera®).

• IRAS ID

  159277

• Contact name

  Mark Nelson

• Contact email

  mark.nelson@chelwest.nhs.uk

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2014-002284-15

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  Most people who commence treatment for HIV in the UK, start with a regimen that includes efavirenz (EFV) in combination with other antiretrovirals.
  The majority of patients take efavirenz without any significant problems, however a small proportion of patients do experience effects, which may range from mild, tolerable symptoms to more severe symptoms which may require a change of medication to alleviate them. Often these symptoms are related to the central nervous system or CNS (the brain and spinal cord) and may manifest as changes in a patient’s mood, how they think and feel or the quality of their sleep and dreams.
  When we talk about thinking, we refer to how a person takes the information from their 5 senses (sight, sound, touch, smell and taste) and use it to understand the world around them, plan actions and form memories. Some aspects of this can be measured using a series of tests as puzzles which measure reaction times and ability to recall or follow instructions; these are termed neurocognitive tests.
  The purpose of the study is to perform these neurocognitive tests in patients who are taking efavirenz WITHOUT experiencing any side effects related to the CNS and see if there is any improvement after switch from efavirenz to rilpivirine. This will be tested by:

  ? Computerised tests
  ? Questionnaires relating to Central Nervous System (CNS)
  ? Questionnaires about sleep quality and other aspects of neurocognitive wellbeing

  In addition to the computerised tests and questionnaires we will also assess the proportion of doses of medication that you take on time without missing a dose; this is called drug adherence.
  Some people may also be asked to take part in a substudy to assess changes in the brain using advanced Magnetic Resonance Imaging (MRI).

• REC name

  London - Central Research Ethics Committee

• REC reference

  15/LO/0460

• Date of REC Opinion

  27 Mar 2015

• REC opinion

  Favourable Opinion