RecruitingPHASE2INTERVENTIONAL

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).

This research trial, called RIO, is testing new types of HIV treatment known as ‘broadly neutralising antibodies’ (bNAbs) in people who started their HIV medication early after infection. The study aims to find out if combining two long-acting bNAbs can help keep HIV under control if participants pause their usual daily anti-HIV medication. This is a "placebo-controlled, double-blinded" study, meaning some participants will receive the active bNAbs, while others will receive a dummy treatment (placebo), and neither they nor their doctors will know which one they are getting. The trial hopes to enrol 72 people across the UK to understand if these new treatments can prevent the virus from returning after stopping routine medication.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

17 May 2021

Estimated completion

31 Jul 2027

HIV/AIDS and Infections

What is this study about?

This study, known as RIO, is exploring a new approach to managing HIV using special proteins called 'broadly neutralising antibodies' (bNAbs). These bNAbs are designed to target and neutralise many different strains of HIV. The main goal is to see if a combination of two specific long-acting bNAbs can help people who started HIV treatment early keep the virus under control even after they stop their regular daily anti-HIV medication (ART).

If successful, this could be a significant step towards developing new ways to manage HIV that don't involve daily pills, potentially offering more flexibility and improving quality of life for people living with HIV. It’s important to remember that this is a Phase II trial, meaning it's still early-stage research focusing on safety and whether the treatment shows promise.

The trial will involve a 'placebo' group, where some participants will receive a dummy treatment instead of the active bNAbs. This is a standard way to ensure that any observed effects are truly due to the new treatment and not other factors. Neither the participants nor their doctors will know who is receiving the active treatment, which helps make the results as reliable as possible.

Key takeaways

Exploring new long-acting antibody treatments for HIV.
Aims to control HIV without daily medication in some people.
Specifically for those who started HIV treatment early.
Involves regular health checks and close monitoring.
Participation helps future HIV treatment advancements.

Who may be eligible?

To join this study, you would generally need to be an adult from 18 to 60 years old. A key requirement is that you must have started your anti-HIV medication (ART) within six months of first getting HIV, or have a history of starting ART early with a healthy immune system count (CD4 count above 500) and have been on successful ART for at least a year without interruptions.

Your HIV also needs to be effectively controlled by your current medication, meaning the virus is undetectable. Before joining, checks will be done to ensure your specific strain of HIV shouldn't be resistant to the bNAbs being tested. You also cannot have certain other liver conditions like Hepatitis B or C, or other significant ongoing health problems.

Quick self-check

Are you between 18 and 60 years old?
Did you start your HIV medication (ART) within 6 months of diagnosis?
Has your HIV been undetectable on ART for at least the last 12 months?
Do you have any significant other health conditions, like serious liver disease?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you will be one of 72 individuals across various UK hospitals taking part. You will be asked to attend regular appointments for blood tests and health checks. The study aims to see how long HIV remains controlled after stopping your usual daily anti-HIV medication, with the support of the new bNAbs. The length of time you participate will vary, as it depends on when or if the virus starts to become detectable again, which is carefully monitored. The study will involve receiving either the active bNAbs or a placebo, given as an injection or infusion. All details will be fully explained before you agree to join.

Potential risks and benefits

Participating in research trials has potential benefits and risks. While you might not directly benefit from being in this study, you would be helping us learn more about new ways to manage HIV, which could benefit others in the future. Potential risks could include side effects from the bNAbs, or your HIV becoming detectable again after stopping your usual medication, which will be closely monitored. You will receive very careful medical attention throughout the study. Remember, joining is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Aarhus University Hospital
Aarhus, Denmark· Recruiting
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom· Recruiting
Western General Hospital
Edinburgh, United Kingdom· Recruiting
Imperial College NHS Healthcare Trust
London, United Kingdom· Recruiting
Barts Health NHS Trust
London, United Kingdom· Recruiting
Chelsea And Westminster Hospital NHS Foundation Trust
London, United Kingdom· Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom· Recruiting
Mortimer Market CNWL Hospital NHS Foundation Trust
London, United Kingdom· Recruiting
Royal Free London NHS Foundation Trust
London, United Kingdom· Recruiting
St Georges Hospital NHS Foundation Trust
London, United Kingdom· Recruiting
Manchester University NHS Foundation Trust
Manchester, United Kingdom· Recruiting
Oxford University Hospitals
Oxford, United Kingdom· Recruiting

Common questions

What are broadly neutralising antibodies (bNAbs)?

They are special proteins that can fight off many different types of HIV. Scientists hope they could be a new way to treat or manage HIV.

What does 'placebo-controlled' mean?

It means some participants will receive the active new treatment, while others will receive a dummy treatment (placebo). This helps researchers see if the new treatment really works.

Will I have to stop my regular HIV medication?

The study aims to see if these new antibodies can control HIV after participants pause their daily anti-HIV medication. This will only happen under very close medical supervision.

Who can join this study?

Generally, adults aged 18-60 who started HIV medication early after infection and whose virus is currently well-controlled are eligible. Specific health checks will be needed too.

What happens if the treatment doesn't work for me?

Your doctors will closely monitor your health and HIV levels. If the virus starts to become detectable, your regular anti-HIV medication will be restarted.

How to find out more

Stephen Fletcher

rio_trial@imperial.ac.uk +44 (0) 20 7594 7324 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.