Status:
COMPLETED
Men Who Have Sex With Men (MSM) Neurocog 1&2 Study
Lead Sponsor:
St Stephens Aids Trust
Conditions:
HIV Related Neurocognitive Impairment
Eligibility:
MALE
18-49 years
Brief Summary
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...
Detailed Description
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 fa...
Eligibility Criteria
Inclusion
- All subjects
- 18-49 years inclusive
- Identifying as MSM
- Willing and able to provide written informed consent
- Able to complete screening tools.
- Fluent in spoken and written English
- Patients who have given written and dated informed consent to participate in this study and to use the data.
- Patients co-infected with chronic hepatitis B/C (diagnosed serologically at least 6 months prior to study to exclude seroconversion/recent infection) and/or currently using recreational substances including alcohol will be included in this study ("real world" data)
- HIV-infected subjects • Known HIV of at least 6 months duration (in order to exclude symptoms associated with primary HIV infection)
- HIV-uninfected controls
- HIV-negative by rapid point of care test (POCT) or standard laboratory testing
- No unprotected anal intercourse (UPAI) in last 3 months
Exclusion
- All subjects
- HIV or hepatitis B/C infection thought to have occurred in the last 6 months
- Current/active central nervous system (CNS) opportunistic infections or CNS malignancies.
- Previous cerebrovascular accidents (CVA/stroke) or history of transient ischemic attacks (TIAs).
- Neuromuscular disease that will limit ability to perform the screening tests.
- Patients receiving current therapy with ribavirin or interferon for hepatitis co-infection or expected to start such therapy in the coming 12 months
- Current medical or psychiatric/psychological condition deemed significant by the investigator o (e.g. psychosis, bipolar disorder, dementia, eating disorders, severe head injury (loss of consciousness for at least an hour), current CNS opportunistic infection)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT01508559
Start Date
September 1 2011
End Date
December 1 2013
Last Update
April 11 2014
Active Locations (1)
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1
SSAT Clinical Trials Unit
London, United Kingdom, SW10 9NH