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Study on Topiramate for Reactivating Hidden HIV in Patients with HIV on Antiretroviral Therapy

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 effects of the medication topiramate on people living with HIV-1, a type of human immunodeficiency virus. Participants in this study are individuals who are already receiving antiretroviral therapy, which is a standard treatment for managing HIV. The purpose of the study is to explore whether topiramate can help reactivate hidden HIV in the body, which could potentially lead to new ways of managing the virus.

During the study, participants will receive topiramate in the form of a film-coated tablet taken orally. The study will monitor how the medication affects the virus and assess the safety and tolerability of topiramate in these individuals. Participants will be observed for any changes in the virus and any side effects they might experience while taking the medication.

The trial will take place over a period of time, with regular check-ins to track the progress of the treatment and its effects on the participants. The study aims to provide valuable insights into the potential role of topiramate in managing HIV-1, contributing to the ongoing efforts to improve treatment options for people living with this condition.

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

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria. These include having documented HIV-1, being 18 years or older, and having been on antiretroviral therapy (ART) for at least two consecutive years.

    Participants must have an HIV-1 RNA plasma level of less than 30 copies/mL for at least two consecutive measurements before joining the study. A CD4+ T cell count of 200 cells/mm3 or more is also required.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to establish baseline measurements. This includes measuring cell-associated (CA) HIV-1 RNA levels and other health indicators.

    Participants are informed about the study procedures and provide informed consent.

  3. Step 3

    Medication administration

    Participants begin taking topiramate orally. The dosage and frequency are determined by the study protocol.

    The primary goal is to assess the effect of topiramate on HIV reactivation in individuals on ART.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for changes in CA HIV-1 RNA levels at specific time points: 6 hours (T2) and 24 hours (T3) after topiramate administration, compared to baseline (T0).

    The frequency and severity of any adverse events are recorded to evaluate the clinical safety and tolerability of topiramate.

  5. Step 5

    Data collection and analysis

    Data on plasma concentrations of topiramate and changes in the HIV reservoir size are collected and analyzed.

    Comparisons are made between different study arms to assess the effectiveness and safety of the treatment.

  6. Step 6

    Completion

    The study is estimated to conclude by September 1, 2025. Final assessments are conducted to gather comprehensive data on the study's outcomes.

    Participants receive information about the study results and any implications for their ongoing treatment.

Who can join the trial?

6 criteria

  • You must have a documented infection with HIV-1, which is a type of virus that affects the immune system. Specifically, you should have subtype B or C.
  • You need to be aged 18 or older.
  • You should have been on antiretroviral therapy (ART) for at least 2 continuous years. ART is a treatment that helps control the HIV virus.
  • Your HIV-1 RNA plasma level should be less than 30 copies per milliliter for at least two consecutive tests before joining the study. This means the amount of virus in your blood is very low. Occasional small increases, called viral blips, are okay if they are between 30-200 copies per milliliter and are followed by levels below 30 again.
  • Your CD4+ T cell count should be 200 cells per cubic millimeter or higher at the time of screening. CD4+ T cells are a type of white blood cell important for your immune system.
  • You must be able to understand the study information and give your agreement to participate, known as informed consent.

Who cannot join the trial?

5 criteria

  • Individuals who are not living with HIV-1 cannot participate. HIV-1 is a type of virus that affects the immune system.
  • Participants must be on antiretroviral therapy. This is a treatment for people with HIV that helps control the virus.
  • People who are not within the specified age range cannot join. The age range is not specified here, but it is important for eligibility.
  • Both males and females can participate, so gender is not a reason for exclusion.
  • Individuals who are considered part of a vulnerable population are not excluded. A vulnerable population includes groups that might need special protection.
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Investigated drugs

Topiramate is a medication being studied for its potential to reactivate the HIV-1 reservoir in people living with HIV who are already on antiretroviral therapy. The trial aims to see if this medication can help in managing HIV by targeting the virus that remains hidden in the body. Additionally, the study will evaluate how safe and tolerable topiramate is for patients.

What is already known about the treatment

Topiramate – Topiramate is administered orally, typically in tablet or capsule form. It is currently being studied in a phase II clinical trial to evaluate its effect on the reactivation of the HIV-1 reservoir in individuals living with HIV who are on antiretroviral therapy. The main therapeutic indication under investigation is its potential role in managing HIV-1. At the molecular level, topiramate is believed to work by modulating neurotransmitter activity, although its exact mechanism in HIV reactivation is still being explored. It is classified pharmacologically as an anticonvulsant, commonly used to treat epilepsy and prevent migraines.

Investigated diseases

Human Immunodeficiency Virus 1 (HIV-1) – HIV-1 is a virus that attacks the immune system, specifically targeting CD4 cells, which are crucial for immune defense. Over time, the virus can weaken the immune system, making the body more susceptible to infections and certain diseases. Initially, individuals may experience flu-like symptoms, but as the virus progresses, it can lead to a more severe condition known as Acquired Immunodeficiency Syndrome (AIDS). The progression of the disease varies among individuals, with some experiencing rapid advancement while others may remain asymptomatic for years. HIV-1 is primarily transmitted through contact with infected bodily fluids, such as blood, semen, and vaginal fluids. The virus can be managed with antiretroviral therapy, which helps to control its replication and maintain immune function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511532-27-00Estimated enrolment12 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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