#1 Clinical Trials Search in Europe

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

1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Agfvodhit Uvq Amsterdam The Netherlands
Eqnsjie Utlrbrudllbq Mozkidj Cprrhpu Rxmexgsju (qzhmmvd Mtt Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.04.2024

Trial locations

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.

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 ID:
2024-511192-15-00
Protocol code:
1.6
NCT ID:
NCT06240520
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study of islatravir and ulonivirine for adults with HIV who have not received previous treatment

    Recruiting

    1 1 1
    Investigated drugs:
    France Spain

  • A study testing VH4524184 with emtricitabine and tenofovir alafenamide compared to dolutegravir and lamivudine in adults with HIV-1 who have not received treatment before

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Italy Poland Portugal +1