VIRIAS
Research type
Research Study
Full title
Viral reservoir integration analysis study; Sub-study of Evolutionary Dynamics of Viral Reservoir Cells
IRAS ID
341972
Contact name
Sarah Fidler
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
This project will explore the immune and viral correlates of natural control of HIV virus amongst some rare individuals who are able to remain fit and well without taking medicines.
Most people living with HIV need to take medicines every day for the rest of their life in order to control virus infection and keep them well. Rarely some people can control virus without tablets. To help us better understand how they are able to do this we would like to take some extra blood tests to measure the HIV virus and also markers of their immune system.
The aim is to recruit up 25 participants, from three different clinical groups; one group are virus controllers who are not on HIV medicines (from the IDRIS clinic, St Mary’s Hospital, London). Another is people living with HIV who are on antiretroviral treatment for HIV and, who were previously in another study testing an HIV vaccine (RIVER trial). Finally, a control group of people who are HIV negative. They will be asked to attend up to two visits, six months apart where a blood sample will be taken for research. There will also be an initial visit for screening where blood and pregnancy test will be performed.
Lay summary of study results: About HIV Most people with HIV experience viral rebound in plasma on stopping ART. The source of this rebounding virus is from a pool of latently infected cells; the so-called HIV reservoir, which persists lifelong despite antiretroviral therapy. However, certain rare people (0.5-1%); so-called viral controllers, can spontaneously control HIV replication to undetectable levels (< 20 copies HIV RNA/ml) without taking ART.
Aim of the study
VIRIAS study is trying to understand the nature of the HIV-specific immune responses and the characteristics of the HIV reservoir in such individuals. Further with the understanding help to inform the design of novel innovations that may enable viral control without the need for ART. Imperial College London is the Sponsor and the lead of the study. We involved one site, St Mary’s Hospital.Method and activities
Study visits took place between October 2024 and July 2025 and 24 participants at St Mary’s Hospital site. It was funded by Bill and Melinda Gates Foundation, where Massachusetts General Hospital (MGH) is the lead institute. The study proposal was discussed with patient representative at design stage of the study. Participants living with HIV and exhibiting viral control were selected from the IDRIS clinic and second group were participants who had previously taken part in the RIVER study. A third group of participants were the control group and consisted of people living with HIV.
The study aimed to recruit 25 participants across all three groups, with 10 in viral control, 10 in RIVER and 5 in control respectively. In total 24 participants were enrolled – 9 were in viral control group, 10 in RIVER and 5 in control groups. The study consisted of a screening visit and a blood donation visit. At the blood donation visit, the participant’s medical history was also taken. The optional second blood donation visit was completed by two of the participants six months after the first visit. There were four adverse events reported and all incidents were immediately resolved.Results
The end of study was defined as when the final data was entered on the database. As of July 2025, 14 participant samples have been sent to MGH for further analysis into the HIV reservoir. Sample analysis is still ongoing and the estimated time of results is set to be end of 2027. The reason full sample analysis is pending, is because VIRIAS is part of a bigger research programme to build a HIV reservoir network, of seven cohorts from 12 different site, to look at a variety of assays which is still ongoing. All remaining VIRIAS samples are stored at University Oxford lab and separate aim on the immunological outcomes of the VIRIAS participants is also being analysed by University of Oxford. The findings will be published jointly with Massachusetts General Hospital before end of December 2027.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: The study results will be published in peer reviewed journals and will be presented at national and international meetings such as BHIVA and Conference on Retroviruses and Opportunistic Infections (CROI).Full anonymity of participant's details will be maintained throughout and no individual participant data will be presented.
A newsletter summarising the research findings in lay language will be made available once the study results have been reported.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0142
Date of REC Opinion
29 Jul 2024
REC opinion
Further Information Favourable Opinion