AuthorisedTherapeutic exploratory (Phase II)Interventional

Curing HIV: proof of concept randomized clinical trial with Pyrimethamine, Lenalidomide, TOpiramate (PLUTO)

This clinical trial, named PLUTO, is exploring new ways to potentially cure HIV-1. Researchers are testing a combination of three existing medications: lenalidomide, pyrimethamine, and topiramate. This is a Phase II study, meaning it’s an early step to see if these drugs can affect the HIV virus in the body and if they are safe for people with HIV-1. The study will look closely at changes in the amount of HIV in cells and blood, and also monitor any side effects. Participants' experiences, including their satisfaction and quality of life, will also be important measures. The goal is to understand if this drug combination could be a stepping stone towards a future cure for HIV.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

24 Apr 2026

HIV-1

What is this study about?

Imagine the HIV virus is like a hidden enemy that can sometimes 'sleep' inside your cells, making it hard for current medicines to get rid of it completely. This study, called PLUTO, is trying to find ways to 'wake up' these sleeping viruses so they can be targeted and potentially removed from the body. Researchers are focusing on a combination of three medicines that are already used for other health conditions: lenalidomide, pyrimethamine, and topiramate.

This is a 'Phase II' trial, which means it's an early stage of research. The main goals are to see how well these medicines work together to activate the hidden HIV virus and how safe they are for people living with HIV-1. The scientists will be looking at changes in the amount of HIV in blood and cells. They will also carefully watch for any side effects and understand how people feel about the treatment, including their quality of life.

The information gathered from this study is really important. It helps doctors and scientists understand if this particular combination of drugs could be a promising step towards developing new treatments, and ultimately, a cure for HIV. Even if it doesn't lead to a cure right away, it provides valuable knowledge that could help future research.

Key takeaways

The PLUTO study is investigating a new drug combination to 'wake up' hidden HIV.
It uses existing medicines: lenalidomide, pyrimethamine, and topiramate.
This is an early-stage (Phase II) trial focusing on how the drugs affect the virus and their safety.
Participation involves taking the study drugs, blood tests, and sharing your experiences.
The goal is to gather crucial information for future HIV treatments and potential cures.
You can withdraw from the study at any time.

Who may be eligible?

To take part in the PLUTO study, you need to be at least 18 years old. There’s no upper age limit, meaning older adults can also participate.

Both men and women are welcome to join this study. The researchers want to include a wide range of people to understand how the medicines affect different individuals.

Beyond these basic requirements, the study will have other specific health checks to make sure the treatment is safe and appropriate for you. Your doctor or the study team will go through all the details if you are interested in taking part.

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 18 years old or older?
Are you living with HIV-1?
Are you willing to take the study medications?
Are you comfortable with regular blood tests and answering questionnaires?
Are you able to attend study visits as required?

Answer every question to see your result.

What does participation involve?

If you decide to join the PLUTO study, you will be given a combination of three medicines: lenalidomide, pyrimethamine, and topiramate. The study is divided into two main parts. In the first part, you'll have blood samples taken at the beginning (before treatment), then at 6 hours, 24 hours, and 7 days after starting the treatment. These samples will help researchers understand how the drugs are affecting the virus very early on. You'll also answer questionnaires about your satisfaction and how you feel, and have an interview.

The second part of the study will involve similar blood tests, but with a longer follow-up period. You'll have blood tests at the beginning and then again after 4 weeks. During this time, the researchers will check your blood for both the virus and the levels of the study medicines. They will also keep a close eye on your health, noting any side effects or changes. You will also fill out questionnaires about your well-being over those 4 weeks. The total duration of your active participation will depend on which part of the study you are in, but the main intense monitoring periods are 7 days for the first part and 4 weeks for the second part.

Potential risks and benefits

Taking part in this study could potentially offer an early opportunity to try a new drug combination that might help eliminate the HIV virus from your body, contributing to the search for a cure. However, like all medicines, the drugs used in this trial (lenalidomide, pyrimethamine, and topiramate) can have side effects. Researchers will carefully monitor you for any unwanted effects to ensure your safety. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is the main goal of the PLUTO study?

The main goal is to see if a combination of three existing medicines can help 'wake up' and target the hidden HIV virus in cells, moving us closer to a cure.

What are lenalidomide, pyrimethamine, and topiramate?

These are three medicines already used for other health conditions. Researchers are now testing if they work together against HIV.

Will I be cured of HIV if I join this study?

This is an early-stage study, so it's too soon to say if it will lead to a cure for individuals. It aims to gather important information for future treatments.

What kind of tests will I have?

You will have regular blood tests to check your HIV levels and monitor the drug levels and your general health. You'll also complete questionnaires and interviews.

What is a 'Phase II' study?

Phase II means it's an early step in testing new treatments. It focuses on how well the treatment works and its safety in a small group of people, after initial safety tests.