AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimen

This research trial is for people living with HIV who are already doing well on their current medication, meaning the virus in their blood is very low. The study wants to see if switching to a new combination of two medicines, called doravirine (Pifeltro) and raltegravir, can continue to keep the HIV under control. Researchers will be carefully monitoring participants for 48 weeks (about 11 months) to check if the virus stays suppressed and to look for any side effects. The aim is to find out if this new dual treatment is effective and well-tolerated as a way to maintain good health in people with HIV. It's an important step in finding the best ways to manage HIV long-term.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre de Recherches et d’Etudes sur les Pathologies Infectieuses, Tropicales et le VIH/Sida

Enrolment target

118

Start

13 Dec 2024

HIV Disease

What is this study about?

This study is a clinical trial exploring a new approach to managing HIV. It focuses on people who are already successfully controlling their HIV with their current medication, meaning the amount of virus in their blood is very low (undetectable). The main idea is to see if a simpler treatment plan, using just two medicines instead of possibly more, can still keep the HIV virus under control just as well.

The two medicines being tested together are doravirine (also known as Pifeltro) and raltegravir. These are both types of anti-HIV drugs that work in different ways to stop the virus from multiplying. The study will mainly look at whether these two drugs, when used together as a new combination, can maintain this very low viral level for at least 48 weeks. Researchers will also be checking for any side effects and how people feel overall.

Finding effective and simpler treatment options is important for people living with HIV. It could lead to fewer pills, potentially fewer side effects in the long run, and an easier daily routine for managing the condition. This research helps doctors understand if this specific combination offers a good alternative for maintaining long-term health for people with HIV.

Key takeaways

This study evaluates a two-drug HIV treatment, doravirine and raltegravir.
It's for people already successfully managing their HIV with low virus levels.
The main goal is to see if this new combination keeps the virus suppressed over 48 weeks.
Participants will have regular clinic visits, blood tests, and fill out questionnaires.
Finding simpler, effective treatments can improve quality of life for people with HIV.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and living with HIV. Both men and women can take part.

Crucially, you must already be successfully managing your HIV. This means that for a while now, tests have shown only a very small amount of HIV in your blood – so little that it's considered 'undetectable' (below 50 copies of the virus per millilitre of blood). You need to have been on your current HIV medication and maintaining this low virus level.

This study is for people who are stable on their current treatment and meet other specific health checks that the study doctors will go through with you. If you're currently having problems with your HIV treatment or your virus levels are rising, this study would not be suitable.

Quick self-check

Are you 18 years old or older?
Do you have HIV?
Is your current HIV treatment working well, with very low virus levels (below 50 copies/mL)?
Have you been on your current treatment and maintained these low virus levels for a while?

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

What does participation involve?

If you join this study, you would switch from your current HIV medication to the new combination of doravirine (Pifeltro) and raltegravir. You would take these tablets as prescribed by the study team.

You would have regular appointments at the clinic for about 48 weeks (around 11 months). These visits will involve blood tests to check your HIV levels, your general health, and how your immune system is doing. You'll also be asked to fill out questionnaires about your quality of life and how you're taking your medication, to help the researchers understand your experience.

Some participants might also have additional tests, if they agree. For example, a small number of people might have samples taken from fluid around the brain and spinal cord, or from male genital fluid, to see how the drugs work in those areas. These additional tests are optional and would be discussed with you thoroughly.

Potential risks and benefits

Participating in this study might offer the benefit of switching to a potentially simpler and effective two-drug HIV treatment. This could lead to a more manageable daily routine. As with any medication, there's a possibility of side effects, which the study team will carefully monitor. You might also find the regular clinic visits a time commitment. It's very important to remember that joining any study is completely your choice, and you have the right to withdraw at any time without giving a reason, and this won't affect your medical care.

Locations (3)

—
Spain
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Italy
—
France

Common questions

What is 'virological success'?

It means your HIV is well-controlled, with very low levels of the virus in your blood, less than 50 copies per millilitre.

What are doravirine and raltegravir?

They are both medicines for HIV that work by stopping the virus from making more copies of itself in your body.

How long will I be in the study?

The main part of the study where you're closely monitored with regular visits is for 48 weeks, which is about 11 months.

Will I know which treatment I'm getting?

Yes, in this study, everyone will receive the new combination of doravirine and raltegravir. It's not a study where you get a dummy pill.

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

The study team will monitor your virus levels very closely. If your HIV starts to become detectable, they will work with you to find a different treatment plan immediately.