HIV, Neuropathic Pain, Sensory Neuropathy
Conditions
Keywords
HIV, Sensory Neuropathy
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo Intervention
No intervention - observational only
Sponsors
Imperial College London
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or over * HIV infection
Exclusion criteria
* co-incident severe neurological disease * co-incident severe psychiatric illness * limited english language skills so as not able to conduct quantitative sensory testing * pregnancy * pain of greater than 3/10 on an NRS due to pathology other than HIV-SN
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview | Day 1 | Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set | Day 1 | 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. |
| Conditioned Pain Modulation Efficiency | Day 1 | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
NA all recruited were included
Participants by arm
| Arm | Count |
|---|---|
| Total Cohort Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy or neuropathic pain) | 148 |
| Total | 148 |
Baseline characteristics
| Characteristic | Total Cohort |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 7.1 |
| Employment Employed | 79 Participants |
| Employment Not working through illness | 41 Participants |
| Employment Retired | 18 Participants |
| Employment Unemployed | 10 Participants |
| Race/Ethnicity, Customized Black | 22 Participants |
| Race/Ethnicity, Customized Other | 9 Participants |
| Race/Ethnicity, Customized White | 117 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 148 |
| other Total, other adverse events | 0 / 148 |
| serious Total, serious adverse events | 0 / 148 |
Outcome results
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
Time frame: Day 1
Population: Adults with HIV infection
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Cohort | Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview | DN4 >3 | 81 Participants |
| Total Cohort | Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview | DN4 <4 | 67 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.
Time frame: Day 1
Population: All participants that completed Cogstate cognitive function testing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Cohort | Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set | 48.09 T-score for global measure of function | Standard Deviation 8.07 |
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.
Time frame: Day 1
Population: All subjects who completed full Conditioned Pain Modulation protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Cohort | Conditioned Pain Modulation Efficiency | 0.78 kPa | Standard Deviation 0.8 |