Topiramate for Human immunodeficiency virus 1 (HIV-1) infection

Inclusion criteria

• {"criterion_text":"- •\tDocumented HIV-1, subtype B or C\n- •\tAged 18 or over\n- •\tOn ART for a minimum of 2 consecutive years\n- •\tHIV-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)\n- •\tCD4+ T cell count ≥200 cells/mm3 at screening\n- •\tAble to understand the information and give informed consent"}

Exclusion criteria

• {"criterion_text":"- •\tAny major acute medical condition requiring hospitalisation within the past 4 weeks.\n- •\tPresence of an active opportunistic infection that defines acquired immunodeficiency syndrome (AIDS).\n- •\tAny medical condition deemed by the investigator to hinder compliance with the study treatment.\n- •\tThe following laboratory values at the screening phase (available before baseline (T0)):\n- o\tHepatic transaminases (AST or ALT) ≥3 times the upper limit of normal.\n- o\tSerum total bilirubin ≥3 times the ULN.\n- o\tEstimated glomerular filtration rate (eGFR) ≤60 mL/min based on CKD-EPI.\n- o\tHaemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females)\n- o\tLeucocytes <2.5 x109/L\n- o\tAbsolute neutrophil count <1000 cells/mm3\n- o\tThrombocytes <100 x109/L\n- •\tActive 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.\n- •\tParticipants who are unwilling or unable to use barrier contraception during sexual intercourse during the study.\n- •\tHistory of suicide or suicidal ideation.\n- •\tHistory 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.\n- •\tHistory of any medical condition with a causal relationship with hyperammonemia.\n- •\tParticipants using phenytoin, carbamazepine, digoxin, lithium, or valproic acid throughout the trial period.\n- •\tAny concurrent medicine use associated with hyperammonemia (e.g. valproic acid).\n- •\tParticipants with active substance abuse.\n- •\tParticipants who have registered allergies to the investigational medical product."}

Primary endpoints

• {"endpoint_text":"- 1.\tThe fold change in cell-associated (CA) HIV-1 RNA after topiramate treatment (T2 (6h), T3 (24h)) compared to baseline (T0).\n- 2.\tThe frequency and severity of adverse events after topiramate treatment.","definition_or_measurement_approach":"1. Measured as fold change in cell-associated (CA) HIV-1 RNA at timepoints T2 (6h) and T3 (24h) compared with baseline (T0). 2. Measured as frequency and severity of adverse events (AE reporting) after topiramate treatment."}

Secondary endpoints

• {"endpoint_text":"- 1.\tThe change in CA HIV-1 RNA compared between arms.\n- 2.\tPlasma concentrations of topiramate compared between arms.\n- 3.\tThe frequency and severity of adverse events compared between arms.\n- 4.\tThe change in reservoir size after topiramate treatment compared to baseline.\n- 5.\tThe plasma concentration of topiramate compared to CA HIV-1 RNA.","definition_or_measurement_approach":"Endpoints are comparative between study arms: 1. Change in CA HIV-1 RNA compared across arms. 2. Plasma concentrations of topiramate measured and compared between arms. 3. Frequency and severity of AEs compared between arms. 4. Change in HIV reservoir size post-treatment compared to baseline. 5. Correlation/comparison of plasma topiramate concentration with CA HIV-1 RNA."}

Netherlands

Earliest CTIS Part Ii Submission Date

12-06-2024

Latest Decision Or Authorization Date

13-10-2025

Processing Time Days

488

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands