All studies
Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Optimizing reversal of HIV latency with combination therapy (pyrimethamine, lenalidomide, panobinostat)

This research trial, called 'Optimizing reversal of HIV latency', is exploring a new way to target HIV-1. HIV can hide in the body in a 'sleeping' state, making it hard for current treatments to get rid of it completely. This study is testing a combination of three existing medications – pyrimethamine, lenalidomide, and panobinostat – to see if they can 'wake up' this hidden HIV. The aim is to make the virus visible to the body's immune system and existing treatments, potentially leading to better control of the infection. Researchers will carefully measure how well the combination works and if there are any side effects. It’s an important step in understanding new ways to manage HIV.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Enrolment target
49
Start
07 May 2024

What is this study about?

This clinical trial is designed to investigate new strategies for managing HIV-1, the most common type of HIV. When someone has HIV, the virus can sometimes hide in certain cells in their body and become inactive, or 'latent'. This 'sleeping' virus is a major challenge because current HIV medications, while very effective at controlling active HIV, can't reach or get rid of these hidden, inactive viruses. This means that even with successful treatment, the virus isn't completely cleared from the body.

This study is testing a new approach called 'kick and kill'. The 'kick' part involves using a combination of three existing medicines – pyrimethamine, lenalidomide, and panobinostat – to try and 'wake up' the hidden HIV. The idea is that once these inactive viruses are woken up, they become active again and, in theory, can then be targeted and eliminated by the immune system or by existing HIV medications – that's the 'kill' part. This trial is in an early stage (Phase II), meaning researchers are still exploring how effective this combination is and whether it's safe.

The main goals of this study are to see how much the combination of these three drugs changes the amount of active HIV in cells, and to carefully monitor any side effects that might occur. Researchers will also look at how these drugs affect the overall amount of HIV in the body, how the immune system responds, and how the drugs are absorbed. By understanding these effects, the study hopes to provide valuable information that could lead to new and improved ways to manage HIV in the future, potentially helping to reduce the amount of hidden virus in people living with HIV.

Key takeaways

  • This study aims to 'wake up' hidden HIV in the body using a combination of existing medications.
  • It's a Phase II trial, meaning researchers are exploring effectiveness and safety.
  • The medications being tested are pyrimethamine, lenalidomide, and panobinostat.
  • Participation involves taking study drugs and having regular health checks and blood tests.
  • This research hopes to find new ways to improve HIV management.
  • You can discuss any concerns with the study team and withdraw at any time.

Who may be eligible?

To be able to join this study, you must be at least 18 years old. Both men and women are welcome to participate.

There will also be other specific health requirements that your doctor will check. These are important to make sure the study is safe for you and that the results are clear. For example, your doctor will need to confirm your HIV diagnosis and check other aspects of your health.

It’s important to discuss your full medical history with the study team. They will carefully review everything to make sure this trial is the right fit for you.

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.

  1. Are you 18 years old or older?
  2. Do you have HIV-1?
  3. Are you able to attend regular clinic appointments?
  4. Are you willing to take the study medications and have blood tests?
  5. Are you able to understand and agree to the study requirements?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the investigational drugs (pyrimethamine, lenalidomide, and panobinostat) as part of the treatment plan. You would have several visits to the clinic for medical check-ups and to provide blood samples. These samples will help the researchers understand how the drugs are affecting the HIV virus and your body. The team will want to monitor your health closely, including checking for any side effects. The exact number of visits, tests, and the total duration of your participation would be explained in detail by the study team, likely over several months, with careful follow-up even after you stop taking the study drugs.

Potential risks and benefits

Participating in this study might offer the potential benefit of helping researchers find new and better ways to manage HIV, which could ultimately benefit you or others living with HIV. However, like all medications, the drugs used in this study (pyrimethamine, lenalidomide, and panobinostat) may cause side effects, which could range from mild to more serious. The study team will carefully monitor you for any reaction and explain all known risks. Your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

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

Common questions

What is 'HIV latency'?

HIV latency means the virus is 'sleeping' and hiding in your cells, making it hard for current medicines to remove it completely. This study is trying to wake it up.

Are the drugs in this study new?

No, pyrimethamine, lenalidomide, and panobinostat are existing medicines. This study is testing them together to see how they work as a combination for HIV.

Will this study cure my HIV?

This study is exploratory research to understand new ways to manage HIV. It is not designed to be a cure, but it contributes to finding better treatments in the future.

What kind of tests will I have?

You'll have regular blood tests to check how the drugs are working against HIV and to monitor your general health and any side effects.

How long will the study last?

The exact duration will be explained by the study team, but clinical trials usually involve multiple visits over several months with follow-up.

How to find out more

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

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