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This study aims to recruit a cohort of HIV patients with and without HIV-SN and to identify genetic risk factors for the development of HIV-SN and neuropathic pain. It also aims to more deeply phenotype the condition, using well validated questionnaires, and to identify any influence that early neurocognitive dysfunction may have on the reporting, diagnosis and treatment of neuropathic pain in the HIV population.
HIV associated sensory neuropathy (HIV-SN) is a frequent complication of HIV infection, affecting between 20 and 57% of infected individuals. The advent of better antiretroviral treatment for HIV has meant that mortality from HIV has decreased dramatically in the UK. This means however, that chronic, age-related conditions associated with HIV, such as HIV-SN and cognitive impairment, are increasing in prevalence and becoming a significant disease burden.
The classification, diagnosis and treatment of HIV-SN remains poor. Currently, little is known about the genetic basis of the disorder and what risk factors mean that some patients with HIV develop neuropathy and pain, whilst others do not. It is hoped that by further characterising or 'phenotyping' the disorder, it will be easier to identify which patients are at risk of developing neuropathy and chronic pain. It may also mean that treatment can be more individualised as currently patients often undergo a frustrating 'trial and error' protocol of treatment, as clinicians can not yet predict who will respond to which treatment.
It has also been suggested that there is a link between HIV-SN and HIV associated neurocognitive disorder (HAND), which is another common, age-related complication of HIV infection. It may be that the existence of one pathology could predict the development of the other, or that the presence of HAND may impair the diagnosis or treatment of chronic pain associated with HIV-SN.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No intervention - observational only |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview | Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set | Cogstate computerised cognitive function testing. A global T-score is a composite measure determined by the arithmetric mean of 8 test scores covering the following cognitive domains: psychomotor function, visual learning, working memory, executive function, emotional recognition, verbal learning, attention and verbal memory. Raw scores were converted to a standardised T score using age adjusted normative data (mean 50; standard deviation 10). Higher scores are interpreted as 'better' cognitive function. |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals over the age of 18 of any gender with HIV
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| Name | Affiliation | Role |
|---|---|---|
| Andrew SC Rice, Prof | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus | London | SW10 9NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33725747 | Derived | Sipila R, Kemp H, Harno H, Rice ASC, Kalso E. Health-related quality of life and pain interference in two patient cohorts with neuropathic pain: breast cancer survivors and HIV patients. Scand J Pain. 2021 Mar 17;21(3):512-521. doi: 10.1515/sjpain-2020-0177. Print 2021 Jul 27. |
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NA all recruited were included
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Cohort | Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy and/or neuropathic pain) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants recruited are included
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Cohort | Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy or neuropathic pain) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview | Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain | Adults with HIV infection | Posted | Count of Participants | Participants | Day 1 |
|
|
Adverse data was recorded for the 24 hours following the single clinical appointment for this observational study - the study did not involve an intervention and the only invasive procedure was a venous blood sample
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Cohort | Observational study whole cohort | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Harriet Kemp | Imperial College London | +44 20 3315 8816 | h.kemp@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2017 | Aug 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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Blood samples
| Day 1 |
| Conditioned Pain Modulation Efficiency | Conditioned Pain Modulation (CPM) efficiency to protocol using a cold noxious stimulus. The CPM efficiency is calculated as the pressure pain threshold (measured with an algometer on the forearm) during the noxious conditioning stimulus minus the pressure pain threshold prior to conditioning stimulus. | Day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
|
| Secondary | Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set | Cogstate computerised cognitive function testing. A global T-score is a composite measure determined by the arithmetric mean of 8 test scores covering the following cognitive domains: psychomotor function, visual learning, working memory, executive function, emotional recognition, verbal learning, attention and verbal memory. Raw scores were converted to a standardised T score using age adjusted normative data (mean 50; standard deviation 10). Higher scores are interpreted as 'better' cognitive function. | All participants that completed Cogstate cognitive function testing | Posted | Mean | Standard Deviation | T-score for global measure of function | Day 1 |
|
|
|
| Secondary | Conditioned Pain Modulation Efficiency | Conditioned Pain Modulation (CPM) efficiency to protocol using a cold noxious stimulus. The CPM efficiency is calculated as the pressure pain threshold (measured with an algometer on the forearm) during the noxious conditioning stimulus minus the pressure pain threshold prior to conditioning stimulus. | All subjects who completed full Conditioned Pain Modulation protocol | Posted | Mean | Standard Deviation | kPa | Day 1 |
|
|
|
| 148 |
| 0 |
| 148 |
| 0 |
| 148 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |