Dual ART in Legacy HABI
Research type
Research Study
Full title
A study to assess dolutegravir and lamivudine as dual antiretroviral therapy in individuals with legacy HIV-associated brain injury
IRAS ID
1010067
Contact name
Alan Winston
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN47418801
Research summary
People living with HIV can experience brain injury caused by the HIV virus multiplying, uncontrolled, in their brain (known as HIV-associated brain injury (HABI)). Modern anti-HIV therapy stops this happening, however, the brain injury that has been caused, often cannot be fully reversed. When a person has experienced brain injury in the past, but the virus is no longer actively multiplying in the brain, it is known as legacy HABI. Anti-HIV therapy has traditionally consisted of three medications (triple therapy) taken in combination. Some of the newer anti-HIV medication are more potent and work better at controlling the HIV virus. Because of this there are now some two medication combinations (dual therapy) that are recommended. Taking two, rather than three, medications may cause less side-effects. The aim of this study is to look at how effective and safe dual anti-HIV therapy is for people with HIV in whom the HIV virus has affected brain health previously. The dual anti-HIV therapy that is being used in this study is a combination of dolutegravir and lamivudine called Dovato.
The research is funded by a grant from ViiV Healthcare and will run across three NHS research sites in London and Brighton. Eligible participants will be living with HIV and, at some point, HIV will have affected the health of their brain, however there will be no evidence that it is continuing to affect their brain health. Participants will be taking triple anti-HIV therapy and have never taken dual anti-HIV therapy.
Participants will be asked to attend at least 11 visits over roughly a 2-year period. Most will be at their routine clinic in the research department. They will complete some questionnaires and brain function (cognitive) tests and have some blood collected. In addition, they will have at least two lumbar punctures (also known as a spinal tap) performed. There will also be 2 scanning visits at a separate imaging facility where a brain (MRI) scan will be done.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0224
Date of REC Opinion
9 May 2025
REC opinion
Further Information Favourable Opinion