Research into topiramate to remove the hidden HIV in people living with HIV taking HIV treatment

Laborértékek

• 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.

• 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