Testing topiramate to wake hidden HIV in people on HIV treatment
Tests topiramate in adults living with HIV who take HIV treatment.
Plain-language title generated from the registry record
Registry title: Research into topiramate to remove the hidden HIV in people living with HIV taking HIV treatment
Key facts
- Where
- Rotterdam, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
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?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- NCT06282783EU 2024-511532-27-00
- Record updated
- 13 October 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.