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Completed

NCT Number: NCT02555930

Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus

London, SW10 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention - observational only

Primary outcomes

  1. Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview

    Time frame: Day 1

    Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain

Secondary outcomes

  1. Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set

    Time frame: 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.

  2. Conditioned Pain Modulation Efficiency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: HIV-POGO

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2015
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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