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

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ClinicalTrials.gov Identifier: NCT02555930
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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.

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.


Condition or disease Intervention/treatment
HIV Sensory Neuropathy Neuropathic Pain Other: No Intervention

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Other: No Intervention
    No intervention - observational only


Primary Outcome Measures :
  1. Neuropathic element of Pain using the Doleur Neuropathique 4 Interview [ Time Frame: Day 1 ]
    DN4-i greater than or equal to 4


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: Day 1 ]
    Cogstate computerised cognitive function testing

  2. Conditioned Pain Modulation [ Time Frame: Day 1 ]
    Parallel CPM protocol using a heat test stimulus of pain 40


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals over the age of 18 of any gender with HIV
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555930


Contacts
Contact: Andrew SC Rice, Prof +44 (0)20 3315 8816 a.rice@imperial.ac.uk
Contact: Harriet I Wordsworth, Dr h.wordsworth@imperial.ac.uk

Locations
United Kingdom
Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus Recruiting
London, United Kingdom, SW10 9NH
Contact: Harriet I Wordsworth, Dr    +44 (0)20 3315 8816    h.wordsworth@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Andrew SC Rice, Prof Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02555930     History of Changes
Other Study ID Numbers: 14/LO/1574
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms