Central Nervous System Health of Broadly Neutralising Antibodies and Interruption of Antiretroviral Therapy in Persons with HIV
Human immunodeficiency virus [HIV] disease
This is a prospective, observational, single-centre clinical study. Twenty (20) persons with HIV, who have stopped daily oral antiretroviral therapy and are participating in a clinical trial which involves the administration of bNAbs, will be enrolled. Potentially eligible participants will be asked to provide their informed consent and attend their routine research clinic for a Screening visit. At this visit, potential participants will: Be asked some questions about themself, their physical and mental health and any medications they take or have taken in the past. If it has not been recorded recently via their parent bNAb study, their height, weight and blood pressure will be measured. They will have a physical examination if they are experiencing any symptoms. They will be asked some questions about their brain health. They will complete some brain function (cognitive) tests. They will complete a questionnaire about their mental and emotional health and wellbeing. If they haven't had their HIV viral load measured within the last 4 weeks, blood will be collected to measure this at this visit. Following the Screening visit, eligible participants will return for a follow-up visit, which consists of 2 parts - brain imaging and lumbar puncture examination. These visits can be done on the same day or within 30 days of each other. These visits should take place within 12 months of the Screening visit. The first part will take place at an imaging facility, which is in a different location from their routine research clinic. They will have an MRI (magnetic resonance imaging) brain scan and have a blood sample collected. Following this, they will attend their routine research clinic, where: They will be asked some questions about their brain health. They will complete some brain function (cognitive) tests. They will complete a questionnaire about their mental and emotional health and wellbeing. They will have another blood sample collected. They will undergo a lumbar
1. Documented HIV-1 infection 2. Full capacity to provide signed informed consent 3. Participating in a clinical trial which involves the administration of bNAbs 4. Has received at least one infusion of a bNAb or placebo 5. Able to comply with the study procedures in the opinion of the investigator
1. Cerebral infections (including AIDS defining illnesses) 2. Contraindication for MRI examination (e.g. claustrophobia, metal implants, physically unable to lie flat) 3. Contraindication to lumbar-puncture examination (at the discretion of the investigator)