Clinical trial NCT02555930: Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study
Official title: Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Sensory Neuropathy
Neuropathic Pain
Keywords: HIV
Sensory Neuropathy
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals over the age of 18 of any gender with HIV

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview
timeFrame: Day 1
Secondary outcomes:
measure: Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set
timeFrame: Day 1
measure: Conditioned Pain Modulation Efficiency
timeFrame: Day 1
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus
Study officials:
affiliation: Imperial College London
name: Andrew SC Rice, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.