SSAT056:Efavirenz to Dolutegravir switch in patients with CNS toxicity
Research type
Research Study
Full title
A phase IV open-label, multi-centre, randomised, dual-arm, pilot study to assess the feasibility of switching individuals receiving Efavirenz with continuing Central Nervous System (CNS) toxicity, to Dolutegravir
IRAS ID
153298
Contact name
Mark Nelson
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2013-004729-94
Research summary
This is a phase IV (Phase 4 trials are done after a drug has been granted a licence), open-label (An open-label trial is a type of trial in which both the researchers and participants know which treatment is being administered), multi-centre trial that will be taking place at 4 sites in the UK.
Efavirenz which is taken in combination with Kivexa® or as part of the combination pill, Atripla® is a recommended first-line regimen for the treatment of HIV-1 infection. Treatment against the HIV virus is also referred to as anti-retroviral therapy.
Toxicity is the most common reason for modification of first-line therapy. Central nervous system (CNS) side effects such as difficulty with sleeping & bad dreams are common side effect of Efavirenz based therapy and is one of the most frequent reasons for switching or discontinuing highly active anti-retroviral therapy.
Dolutegravir is within a novel class of anti-retroviral agents licensed in the UK for the treatment of HIV. In combination with Truvada®, it showed fewer side effects when compared to Efavirenz in other clinical studies, where patients were starting HIV treatment for the first time, or switching from other agents.
The purpose of the study is to investigate the benefits of switching away from Eefavirenz(in combination with Kivexa® or as part of the combination pill, Atripla®) to Dolutegravir in patients with CNS side effects (such as difficulty with sleeping, bad dreams etc). We will investigate the effect of switching Efavirenz to Dolutegravir while continuing Truvada (tenofovir plus emtricitabine, two constituents of Atripla) or Kivexa. Dolutegravir will be the only new component of the combination.
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 treatments.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/1493
Date of REC Opinion
31 Oct 2014
REC opinion
Further Information Favourable Opinion