CTIS2024-511532-27-00进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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)): oHepatic transaminases (AST or ALT) =3 times the upper limit of normal. oSerum total bilirubin =3 times the ULN. oEstimated glomerular filtration rate (eGFR) =60 mL/min based on CKD-EPI. oHaemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females) oLeucocytes <2.5 x109/L oAbsolute neutrophil count <1000 cells/mm3 oThrombocytes <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.
研究者
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