BIC CNS Study
Research type
Research Study
Full title
Brain connectivity and patient reported outcomes in people with HIV (PWH) with symptoms of insomnia switching integrase inhibitor-based ART; a randomised controlled study
IRAS ID
272955
Contact name
Jaime Vera
Contact email
Sponsor organisation
University of Sussex
Eudract number
2019-004007-12
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Current anti-HIV therapy is very effective in controlling the HIV virus and so keeping people well. But there is still much that isn’t known about how taking the drugs affect some parts of the body, such as the nervous system. It also isn’t known what effect different drugs might have on things like how well people sleep.
Within one family of HIV drugs, called “integrase inhibitors” it is thought that difficulty sleeping is higher when taking a drug called dolutegravir. The researchers of this study want to see if taking a different drug from within this family, called bictegravir, might cause less difficulties sleeping.
The study is aiming to recruit 46 participants across two NHS research sites in London and Brighton. The participants will be HIV positive people who are generally well, but have difficulty sleeping (insomnia). They will have been taking a drug called Triumeq, which contains dolutegravir. They will be allocated by chance to either continue taking this or to switch to taking a drug called Biktarvry, which contains bictegravir.
Participants will attend visits over about a 5-month period. There will be 8 visits in total. Six visits will be at the routine clinic where blood and urine will be collected and several questionnaires completed. Two visits will be at a separate imaging centre where a brain scan will be performed.REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0116
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion