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Study on Reversing HIV Latency Using Pyrimethamine, Lenalidomide, and Panobinostat for People Living with HIV

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of HIV-1, a virus that attacks the immune system. The study will use a combination of three medications: pyrimethamine, lenalidomide, and panobinostat. These medications are taken orally, meaning they are swallowed in the form of tablets or capsules. The purpose of the study is to explore how these medications can help reactivate the virus from its hidden state in the body, which is known as latency, and to assess how well people tolerate these treatments over time.

Participants in the study will receive the combination of medications and will be monitored at different times to see how the virus in their body responds. The study will also look at any side effects that might occur from taking these medications. The trial aims to understand how the virus's hidden reservoirs react to the treatment and how the immune system responds. This information will help researchers learn more about managing HIV-1 and potentially improving treatment strategies.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study will last for a specific period, during which the researchers will collect data on the virus's activity and any changes in the participants' health. This research is important for finding new ways to manage HIV-1 and improve the quality of life for those living with the virus.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including documented HIV-1 infection and adherence to antiretroviral therapy (ART).

    Participants must be at least 18 years old and have a stable health status as defined by the World Health Organization (WHO) performance status 0 or 1.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes evaluating the current plasma HIV RNA levels and CD4+ T-cell count.

    The baseline data will be used to compare changes throughout the study.

  3. Step 3

    Medication administration

    Participants will receive a combination of three medications: panobinostat, pyrimethamine, and lenalidomide. All medications are taken orally.

    The dosage and frequency of each medication will be determined by the study protocol and monitored by the research team.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the effects of the medications on HIV reservoir reactivation and tolerability.

    Participants will have scheduled visits to measure changes in cell-associated HIV-RNA and to monitor any adverse events.

  5. Step 5

    Evaluation of outcomes

    Primary outcomes include the change in HIV-RNA levels at specific time points and the assessment of any adverse events related to the medications.

    Secondary outcomes involve evaluating the change in the HIV reservoir size, immune activation levels, and drug plasma concentrations.

  6. Step 6

    Completion of the study

    The study is expected to conclude by April 2025. Final assessments will be conducted to compare data from the start to the end of the study.

    Participants will receive a summary of their individual results and any relevant findings from the study.

Who can join the trial?

11 criteria

  • Must have a documented infection with HIV-1, confirmed by specific tests like 4th generation ELISA, Western Blot, or PCR.
  • Must be 18 years old or older.
  • Must have a World Health Organization (WHO) performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
  • Must have a current plasma HIV RNA level of less than 50 copies per milliliter, measured on the last two occasions, with these measurements being at least 3 months apart.
  • Must have been on uninterrupted prescribed antiretroviral therapy (ART) for at least two consecutive years.
  • Must be considered more than 95% adherent to ART by their treating physician, meaning they take their medication as prescribed most of the time.
  • Must have a current blood CD4+ T-cell count of 200 cells per cubic millimeter or more. CD4+ T-cells are a type of white blood cell important for the immune system.
  • Must not show clinical signs of cellular immunodeficiency or AIDS.
  • Must have had a pre-ART plasma HIV RNA level of 1000 copies per milliliter or more.
  • Must have a confirmed HIV subtype B. People with a high likelihood of subtype B can participate if they live in a region where subtype B is common and acquired HIV there, even if no HIV sequencing is available or can be done on stored samples.
  • Must be considered mentally and physically capable by their treating physician to understand the informed consent procedure and undergo the study treatment.

Who cannot join the trial?

4 criteria

  • Individuals who do not have HIV-1 cannot participate. HIV-1 is a type of virus that affects the immune system.
  • Participants must be within certain age ranges, specifically adults and older adults.
  • Both males and females are eligible, so exclusion is not based on gender.
  • People who are considered part of a vulnerable population are not excluded, meaning they can participate.
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Investigated drugs

  • Pyrimethamine

    is a medication that is often used to treat and prevent certain types of infections. In this trial, it is being used as part of a combination therapy to help reactivate hidden HIV in the body, which is an important step in trying to reduce the virus's presence.

  • Lenalidomide

    is a medication that can modify the immune system and is used in various treatments, including some cancers. In this study, it is being used to help stimulate the immune system and work alongside other medications to reactivate dormant HIV, making it easier to target and reduce.

  • Panobinostat

    is a medication that affects how certain genes are expressed in the body. It is being used in this trial to help wake up hidden HIV, allowing other treatments to target and potentially eliminate the virus more effectively.

What is already known about the treatment

  • Pyrimethamine

    Pyrimethamine is administered orally in tablet form. It is currently being studied in clinical trials for its potential to reactivate latent HIV reservoirs when used in combination with other agents. The main therapeutic indication for pyrimethamine is the treatment of parasitic infections, but in this trial, it is being explored for HIV-1. Its mechanism of action involves inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis in parasites, and it may help in reactivating dormant HIV. Pyrimethamine is classified as an antiparasitic medication.

  • Lenalidomide

    Lenalidomide is taken orally in capsule form. It is under investigation in clinical trials for its role in reactivating latent HIV when used alongside other medications. While primarily used to treat certain blood cancers, in this context, it is being evaluated for HIV-1. Lenalidomide works by modulating the immune system and has anti-inflammatory properties, which may contribute to its ability to affect HIV latency. It is classified as an immunomodulatory drug.

  • Panobinostat

    Panobinostat is administered orally in capsule form. It is being tested in clinical trials for its potential to reactivate latent HIV reservoirs as part of a combination therapy. The main therapeutic indication for panobinostat is the treatment of certain types of cancer, but it is being explored for HIV-1 in this study. Its mechanism of action involves inhibiting histone deacetylases, which can lead to increased expression of latent HIV. Panobinostat is classified as a histone deacetylase inhibitor.

Investigated diseases

HIV-1 – Human Immunodeficiency Virus type 1 is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for immune defense. Over time, HIV-1 can weaken the immune system, making it difficult for the body to fight off infections and diseases. The virus is transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk. As the virus progresses, it can lead to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of HIV-1 can vary greatly among individuals, with some experiencing rapid progression and others maintaining stable health for many years. The virus can remain dormant in the body, making it challenging to eliminate completely.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511192-15-00Protocol code1.6Estimated enrolment49 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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