An observational study in HIV Related Neurocognitive Impairment, sponsored by St Stephens Aids Trust. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-11.
Sponsored by St Stephens Aids Trust · Observational
The treatment of HIV and the tests performed for HIV care have changed over the last 20 years but improvement of management of HIV-infected subjects is still warranted. The investigators would like to collect and analyse clinical information obtained from subjects who are between 18 and 50 years of age. The investigators will look at routine clinic information such as blood pressure, recent blood test results and clinical history. The investigators will then assess cognitive (brain) function by talking and/or written tests. These tests will include tests for memory, depression and anxiety.
All of those who are identified as having problems with their brain function in this way will be offered onward referral for further assessment as appropriate. Those taking part will be offered a follow up visit at 24-48 weeks after the first assessment to see if there are any changes. This will allow us to understand how brain problems develop, get worse, or get better over time. No genetic research will be done. Depression is a mental health condition that can be characterized by negative feelings, a generally low mood, or problems with eating and sleeping normally. Anxiety is also a mental health condition where a person can feel general anxiousness or fear of specific situations, or, in more serious cases, can have panic attacks. Impaired brain function is a condition of the nervous system or brain where the brain does not function as well as it normally should, and can include symptoms such as forgetfulness, doing everyday tasks more slowly or becoming disorientated to the time of day or the place one is in.
For this study, the investigators will also collect data from medical records, including (and if known)social and educational-related data, HIV infection-related data (e.g. date of diagnosis, blood test results), relevant medical history (e.g. previous psychiatric conditions) and medication used (e.g. date started, the drugs used).
The information the investigators will get from this study will be used to inform healthcare providers (doctor, nurse, health advisor, psychologist) on whether it is necessary to routinely assess HIV infected patients for the presence of anxiety/depression and impaired brain function. The investigators will also get information on whether the treatments used for HIV infection make a difference to how commonly these conditions occur in patients.
The aim of this project is to examine neurocognitive functioning in HIV infected men who have sex with men (MSMs). We have limited our study to this group in order to better study other shared risk factors (hepatitis coinfection, recreational drug use). Given ongoing work in an older cohort our aim is to study neurocognitive impairment in younger subjects (18-49 years). There are two parts to this study. The first is a cross sectional pilot (MSM Neurocog-1) looking at neurocognitive function in HIV infected and HIV uninfected MSMs. The second plan is for a prospective 48 week cohort study 24-48 week study (MSM Neurocog-2) following neurocognitive function in HIV infected subjects and a group of HIV uninfected controls over time.
The shift in HIV care to that of a chronic, manageable condition has transferred focus to long-term morbidities and drug toxicities. One such area in which there is renewed interest is the prevalence and relevance of neurocognitive impairment, as well as the significance of compartmentalised virus in the CSF as compared to blood. Controlled, comparative data are lacking - many of the cross-sectional studies to date have not controlled for important confounders such as recreational and injecting drug use, current or prior co-infections or co-morbidities. Where this has happened, researchers generally use general population controls that may differ markedly from HIV-infected individuals in terms of lifestyle and demographic factors. In addition the paucity of longitudinal data means it is unclear whether an individual with normal neurocognitive function pre-ART will develop impairment later or if subjects with evidence of impairment can expect improvement or normalisation over time; these issues are highly important for clinical management and patient counselling. There is no consensus on which surrogate markers, if any, are important in terms of diagnosing, monitoring and/or predicting neurocognitive impairment. Studies measuring correlation between neurocognitive performance and neuronal markers of inflammation have been conflicting.
St Stephens Aids Trust is the lead sponsor of 45 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV infected and uninfected MSM 18-50 years old
All subjects
HIV-infected subjects • Known HIV of at least 6 months duration (in order to exclude symptoms associated with primary HIV infection)
HIV-uninfected controls
Exclusion Criteria:
All subjects
HIV infected MSM 18-50 years old
HIV uninfected MSM 18-50 years old
Neurocognitive screening score
To describe the prevalence of a positive screening for neurocognitive impairment (NCI) HIV infected and uninfected men who have sex with men (MSM) population using the Basic Neurocognitive Score (BNCS) and International HIV Dementia Score (IHDS) as validated screening tools
Time frame: 0-6 months
Change in neurocognitive function
To follow neurocognitive function over time in a cohort of HIV infected and uninfected MSMs
Time frame: 0-6 months
Demographics
To explore possible correlations between baseline demographics and disease characteristics and prevalence of positive screens for anxiety and/or depressive symptoms and NCI
Time frame: 0-6 months
Biomarkers
To look for possible markers of NCI on MRI scanning or on serological/CSF analysis
Time frame: 0-6 months
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St Stephens Aids Trust