Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
This study, called RHIVIERA-02, is for people in the early stages of HIV infection. It's designed to see if adding special antibodies, called 'broadly neutralising antibodies' (bNAbs), to standard HIV medication (ART) can help control the virus for longer after ART is stopped. Participants will receive either ART plus the new antibodies, or ART plus a placebo (a dummy treatment). After about a year on treatment, ART will be paused to see how their bodies manage the virus. The study is double-blinded, meaning neither the participants nor their doctors will know who is getting the antibodies and who is getting the placebo. Researchers want to understand if these antibodies could offer a new way to manage HIV.
At a glance
What is this study about?
This study, called RHIVIERA-02, is looking for a new and better way to manage HIV, especially for people who have only recently been diagnosed. When someone is first diagnosed with HIV (this is called primary HIV infection), doctors usually recommend starting antiretroviral therapy (ART) straight away. ART is very good at controlling the virus, but it needs to be taken daily for life.
This study is exploring whether adding special antibodies to ART in the early stages of infection can help the body control the virus on its own for longer, even after ART is stopped. These antibodies are called 'broadly neutralising antibodies' (bNAbs). They are designed to attack the HIV virus. The study compares two groups: one group receives ART plus the bNAbs, and the other receives ART plus a dummy treatment (placebo). Neither the participants nor their doctors will know which treatment they are getting. After about a year on ART, participants will pause their ART to see how their body controls the virus. The aim is to find out if the bNAbs can lead to a longer period where the virus stays low without daily medication.
The study involves 69 participants in France who have recently started ART for primary HIV infection. By understanding how these antibodies work, researchers hope to find new strategies that could eventually reduce the need for lifelong daily HIV medication, offering a better quality of life for people living with HIV.
Key takeaways
- New study for people recently diagnosed with HIV (primary HIV infection).
- Compares standard HIV medication (ART) plus new antibodies to ART alone.
- Aims to see if antibodies help control HIV longer after ART is paused.
- Participants will eventually pause ART under close medical supervision.
- Study is 'double-blind', so participants and doctors won't know which treatment is given.
- Could help find new ways to manage HIV without lifelong daily medication.
Who may be eligible?
To be part of this study, you need to meet a few important conditions. You must have been recently diagnosed with HIV-1, meaning you have 'primary HIV infection'. You should be aged between 18 and 70 years old. You also need to be willing to use effective contraception throughout the study if you can become pregnant, and you mustn't be trying to get pregnant. You'll need to agree to travel for treatments and to pause your HIV medication later in the study. You must also give your written permission to take part, and have regular health insurance.
There are also reasons why you might not be able to join. For example, if you are currently pregnant or breastfeeding, or if you have certain other serious health conditions like specific heart problems, active infections like hepatitis C or tuberculosis, or a history of cancer (excluding some skin cancers). You also can't be taking part in another clinical trial that requires extra blood tests. If you have any condition that means pausing your HIV medication would be unsafe, or if you've had a bad reaction to similar treatments in the past, you wouldn't be able to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 70 years old?
- Have you been recently diagnosed with HIV-1?
- Are you willing to use effective contraception (if applicable) and not seeking pregnancy?
- Do you have regular health insurance?
- Are you able to travel for clinic visits and treatment infusions?
- Are you willing to temporarily pause your ART medication, under guidance, later in the study?
What does participation involve?
If you join this study, your time in it will vary, but it will involve several stages. Initially, you'll receive your regular HIV medication (ART) along with either the special antibodies or a placebo. This special treatment will be given by infusion (into a vein). After about 52 weeks (roughly one year) of being on ART, you will pause your ART medication, under close medical supervision. The study team will then closely monitor how your body handles the virus without daily ART. You will have regular visits to the clinic for check-ups, blood tests, and to receive your treatment infusions. The total time you spend in the study will depend on how long it takes for your virus levels to potentially rise after stopping ART, but you will be monitored throughout. You will also need to be vaccinated against COVID-19 as recommended.
Potential risks and benefits
Locations (17)
- Hôpial Avicenne - SMITVerified postcodeBobigny, France· Recruiting
- Hôpital Antoine BéclèreVerified postcodeClamart, France· Recruiting
- Hôpital Beaujon - Service de médecine interneVerified postcodeClichy, France· Recruiting
- CHI Créteil - HdJVerified postcodeCréteil, France· Recruiting
- Hôpital Raymond Poincaré - SMITVerified postcodeGarches, France· Recruiting
- Hôpital Bicêtre - HdJ - Médecine interneVerified postcodeLe Kremlin-Bicêtre, France· Recruiting
- Hôpital Hôtel - DieuVerified postcodeParis, France· Recruiting
- Hôpital Hôtel Dieu - Service d'immunologie cliniqueVerified postcodeParis, France· Not yet recruiting
- Hôpital Pitié-Salpêtrière - SMITVerified postcodeParis, France· Recruiting
- Hôpital Lariboisière - Service de médecine interne AVerified postcodeParis, France· Recruiting
- Hôpital Saint- Louis - SMITVerified postcodeParis, France· Recruiting
- Hôpital Saint-Antoine - SMITVerified postcodeParis, France· Recruiting
Common questions
What are 'broadly neutralising antibodies' (bNAbs)?
These are special proteins designed to target and fight off many different types of HIV. We're hoping they can help the body control the virus better.
What does 'primary HIV infection' mean?
This is the very early stage of HIV infection, usually within a few weeks or months after someone has first contracted the virus.
Will I know if I'm getting the antibodies or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're getting the active antibodies or the dummy treatment until after the study is over.
What happens if I pause my HIV medication (ART) and the virus comes back?
The study team will be monitoring you very closely. If your viral load increases, you will restart your ART medication to keep the virus under control.
How long will I be in the study?
The time varies for each person. You'll be on ART for about a year, and then monitored after pausing ART. The total duration depends on how long it takes for the virus to become detectable again after stopping ART.
How to find out more
Mathilde Ghislain, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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