Testing topiramate to wake hidden HIV in people on HIV treatment
Tests topiramate in adults living with HIV who take HIV treatment.
Key facts
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Where
- Rotterdam, NetherlandsSee the site
- Trial code
- Registry title
- Research into topiramate to remove the hidden HIV in people living with HIV taking HIV treatment
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 12 people, planned
- Started
- 7 Jul 2024
- Planned end
- 1 Sept 2025
- Type of study
- Interventional, 2 groups
- Record updated
- 13 October 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults living with HIV-1 who have taken HIV treatment for at least 2 years and have very little virus in the blood. It tests topiramate.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- HIV-1 subtype B or C; HIV-1 RNA below 30 copies/mL on at least two measurements in a row (short blips of 30-200 copies/mL are allowed); CD4+ T cell count of 200 cells/mm3 or more.
- Earlier treatment
- Must have taken antiretroviral therapy (ART) for at least 2 years in a row.
- Biomarker or test result
- HIV-1 subtype B or C; HIV-1 RNA below 30 copies/mL; CD4+ T cell count of 200 cells/mm3 or more.
Main reasons for not taking part
- Serious illness needing hospital care in the past 4 weeks
- Active infection that defines AIDS
- Liver, kidney or blood test results outside the limits set in the record
- Cancer in the past year, apart from a few listed types
- Using phenytoin, carbamazepine, digoxin, lithium or valproic acid
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Documented HIV-1, subtype B or C • Aged 18 or over • On ART for a minimum of 2 consecutive years • HIV-1 RNA plasma level <30 copies/mL for at least two consecutive measurements prior to inclusion (viral blips with a detectable HIVRNA 30-200 c/mL preceded and followed by HIV-RNA <30 are allowed) • CD4+ T cell count ≥200 cells/mm3 at screening • Able to understand the information and give informed consent
Who cannot take part
- Any major acute medical condition requiring hospitalisation within the past 4 weeks. • Presence of an active opportunistic infection that defines acquired immunodeficiency syndrome (AIDS). • Any medical condition deemed by the investigator to hinder compliance with the study treatment. • The following laboratory values at the screening phase (available before baseline (T0)): o Hepatic transaminases (AST or ALT) ≥3 times the upper limit of normal. o Serum total bilirubin ≥3 times the ULN. o Estimated glomerular filtration rate (eGFR) ≤60 mL/min based on CKD-EPI. o Haemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females) o Leucocytes <2.5 x109/L o Absolute neutrophil count <1000 cells/mm3 o Thrombocytes <100 x109/L • Active malignancy during the past year except for basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi Sarcoma treated with ART alone, or other indolent malignancies. • Participants who are unwilling or unable to use barrier contraception during sexual intercourse during the study. • History of suicide or suicidal ideation. • History of ophthalmological medical problems leading to glaucoma or visual field disturbances (e.g. macula oedema). Refraction abnormalities that can be corrected by lenses are acceptable. • History of any medical condition with a causal relationship with hyperammonemia. • Participants using phenytoin, carbamazepine, digoxin, lithium, or valproic acid throughout the trial period. • Any concurrent medicine use associated with hyperammonemia (e.g. valproic acid). • Participants with active substance abuse. • Participants who have registered allergies to the investigational medical product
Where in Netherlands
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
About the trial
What the trial wants to find out
1. To assess the effect of topiramate on HIV reactivation in people living with HIV on antiretroviral therapy. 2. To evaluate the clinical safety and tolerability of topiramate.
The 2 groups in the trial
- MenTreatment being tested
Sex assigned at birth, male Single dose of 400mg topiramate
Treatment: Topiramate
- WomenTreatment being tested
Sex assigned at birth, female Single dose of 400mg topiramate
Treatment: Topiramate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A phase II clinical trial investigating the effect of topiramate on the reactivation of the HIV-1 reservoir in people living with HIV on antiretroviral therapy
- Plain-language title
- Testing topiramate to wake hidden HIV in people on HIV treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 13 October 2025