The RIO Trial
Research type
Research Study
Full title
The RIO Trial: A randomised placebo controlled trial of ART plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) vs ART plus placebo in treated Primary HIV Infection on viral control off ART
IRAS ID
266322
Contact name
Sarah Fidler
Contact email
Sponsor organisation
Imperial College London NHS Trust
Eudract number
2019-002129-31
Duration of Study in the UK
4 years, 6 months, 31 days
Research summary
Antiretroviral therapy (ART) for the treatment of HIV infection has dramatically improved survival and is highly effective at preventing disease progression to AIDS and onward transmission. However, two key problems remain. The first is that ART is not a cure for HIV infection as it is unable to eradicate a reservoir of persisting, latently infected cells. These are predominantly CD4+ T cells which contain an integrated proviral genome which is transcriptionally-silenced; accordingly these latently infected cells do not produce any virions or viral proteins until they are activated. Eradicating this reservoir is key to curing HIV infection.
The second problem is that ART needs to be taken daily for the entirety of a person’s life. This can lead to treatment fatigue, poor adherence and drug resistance, as well as risks of drug-related long-term toxicities. As a result of these challenges, solutions are being sought to improve how therapy is provided. This has particular relevance for sub-Saharan Africa where ensuring ART drug supplies and helping with adherence requires enormous resources. The additional implications for long-acting therapies to prevent mother-to-child transmission and to help with groups that traditionally have adherence difficulties (e.g. children and adolescents) are potentially game-changing for HIV care delivery. Long-acting broadly neutralising antibodies (bNAbs) targeted against the HIV Env protein are of interest in solving both of these problems.
Individuals who are otherwise healthy and who commenced ART close to the time of HIV acquisition (primary HIV infection, PHI) have the best chance to achieve a period of post-treatment viral control, as the size of the HIV reservoir is small and the immune system is normalised. This study will test the use of bNAbs in participants with treated primary HIV infection (PHI), to see if their use can confer viral suppression in the absence of ART and even induce a period of post-treatment viral control, or ‘remission’, when off all therapies.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1669
Date of REC Opinion
12 Dec 2019
REC opinion
Further Information Favourable Opinion