CV risk in HIV patients switching from a boosted PI to DTG
Research type
Research Study
Full title
An open label study examining the efficacy and cardiovascular risk of immediate versus deferred switch from a boosted PI to dolutegravir (DTG) in HIV infected patients with stable virological suppression
IRAS ID
141310
Contact name
Graeme Moyle
Contact email
Sponsor organisation
St. Stephen's AIDS Trust
Eudract number
2013-003704-39
Research summary
This is a phase IV, randomised (like flipping a coin), open-label (ie all subjects know what medications they are taking at all times), multi-centre trial taking place in up to 8 sites in the UK (and in 25-30 sites in total across Europe).
The purpose of the study is to investigate the benefits of switching away from a kind of drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on participants' cardiovascular health (the health of their hearts). Potential study participants are currently taking two other anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with a boosted PI; these NRTIs will not be changed throughout the study. In order to compare the boosted PI and dolutegravir more accurately, half of study participants will be switched to dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on the boosted PI.
This study will also investigate the safety (in terms of other side effects and the routine blood tests which we ordinarily use to monitor participants' treatment) and monitor effectiveness, participants' viral load and CD4 counts, when participants switch treatment from a boosted PI to dolutegravir. We also aim to improve participants' cardiovascular health in general by providing them with information on how to live a healthy lifestyle (eg improving your diet, stopping smoking etc).
REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0083
Date of REC Opinion
24 Jan 2014
REC opinion
Favourable Opinion