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A study to evaluate the effectiveness of lenalidomide, pyrimethamine, and topiramate in reducing the HIV reservoir in people living with HIV.

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What is this study about?

This study investigates treatments for HIV-1, a virus that attacks the body’s immune system. The goal of the study is to see if a combination of medications can reduce the HIV reservoir, which refers to the hidden groups of infected cells that remain in the body even when the virus is controlled by standard medicine. The medications being tested in this trial are lenalidomide, pyrimethamine, and topiramate.

The research is divided into two parts. The first part involves a one-day treatment to see how the medications affect the virus within certain cells. The second part involves a four-week treatment to evaluate if the combination of drugs can reduce the overall amount of viral genetic material, known as HIV-DNA, present in the body. Participants may receive the active medications or a placebo.

Who Can Join the Study?

  • You must have a confirmed infection of HIV-1, which is a specific type of the virus that causes AIDS. This must be proven through special laboratory tests called Western Blot or PCR, which look for specific markers or the virus’s genetic material in your body.
  • You must be 18 years of age or older.
  • The specific type of the virus you have must be subtype A, B, C, or D. This is determined by sequencing, a process used to read the genetic code of the virus to identify its specific version.
  • You must have been taking ART (antiretroviral therapy, which is the daily medication used to treat HIV) without any interruptions for at least 6 months.
  • Your plasma HIV RNA (the amount of virus found in the liquid part of your blood) must be 50 copies/ml or less. This level must be reached in two separate tests taken at least three months apart.
  • You must not have missed your ART medication for more than 2 days in a single month.
  • Your current CD4+ T-cell count (a type of white blood cell that helps your immune system fight infections) must be 200 cells/mm3 or higher.
  • You must not show any medical signs of cellular immunodeficiency (a weakened immune system) or AIDS (the advanced stage of HIV infection).
  • Before you started ART, your plasma HIV RNA level must have been 1000 copies/mL or higher.
  • You must be able to understand all the information provided about the study and be able to sign an informed consent form, which is a document where you officially agree to participate after being fully informed of the details.

Who Cannot Join the Study?

  • Having used any of the LRAs (a type of drug being studied) within the last 90 days.
  • Having an infection with HIV-2 (a different type of the virus that causes HIV).
  • Having a Hepatitis B infection, unless the infection has been cleared or you have been on continuous antiviral medication for at least 24 weeks with very low levels of the virus in your blood and no signs of advanced liver scarring or cirrhosis.
  • Having a Hepatitis C infection, which is detected by finding the virus in your blood.
  • Taking other medications that could cause a significant interaction with the LRAs.
  • Receiving an mRNA vaccine or an adjuvant vaccine (such as the Shingles vaccine) within the last 4 weeks.
  • Having megaloblastic anaemia (a type of anemia caused by a lack of certain vitamins) due to a lack of folate, or having haemolysis (the premature destruction of red blood cells) that has not been treated.
  • Having had active malignancy (cancer) within the past year, except for specific slow-growing or skin-related cancers.
  • Having a history of attempting suicide or thinking about suicide.
  • Having a history of eye problems that caused glaucoma (increased pressure in the eye) or disturbances in your visual field (the area you can see).
  • Having a history of any medical condition that causes hyperammonaemia (too much ammonia in the blood).
  • Having a history of epileptic seizures within the last year.
  • Having a known allergy to any of the products being tested in this study.
  • Being a sexually active participant who is unwilling to follow specific pregnancy prevention or protection rules, such as using contraceptive measures (methods to prevent pregnancy) or condoms.
  • Having moderate kidney impairment, which is measured by an eGFR (a calculation of how well your kidneys filter blood) of less than 50.
  • Having moderate hepatic impairment (liver problems), which is indicated by high levels of bilirubin or ALT (proteins measured in the blood to check liver health).
  • Having abnormal blood counts, including low haemoglobin (a protein in red blood cells), low neutrophils (a type of white blood cell), low thrombocytes (cells that help blood clot), or abnormal clotting times.

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
Stichting Radboud University Medical Center Nijmegen The Netherlands
Adgmgrzao Ukt Amsterdam The Netherlands
Eyxuzbg Usyqdgsuupfv Mgbotch Cehbahv Rzbboolhh (bsiycqw Msq 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 yet recruiting
04.05.2026

Trial locations

Investigated drugs:

Lenalidomide is a medication used in this study to help reactivate the hidden HIV virus stored in the body so that it can be targeted by other treatments.

Pyrimethamine is an anti-parasitic medication being used as part of a combination therapy to help manage the virus in this clinical trial.

Topiramate is a medication being studied for its role in helping to reactivate the HIV reservoir, which is the collection of hidden virus cells in the body.

Human immunodeficiency virus type 1 – This is a virus that attacks the body’s immune system, specifically targeting cells that help fight infections. Once the virus enters the body, it uses these immune cells to make copies of itself. Over time, the virus can hide in certain cells, creating a reservoir that remains in the body. As the virus replicates, it can gradually reduce the number of healthy immune cells available to protect the body. This process can lead to an increased susceptibility to various infections and illnesses.

Trial ID:
2026-525211-14-00
Protocol code:
2026-525211-14-00
NCT ID:
NCT07384624
Trial Phase:
Therapeutic exploratory (Phase II)

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