Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study (HIV-POGO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02555930|
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : March 9, 2017
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|
|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|
- Other: No Intervention
No intervention - observational only
- Neuropathic element of Pain using the Doleur Neuropathique 4 Interview [ Time Frame: Day 1 ]DN4-i greater than or equal to 4
- Cognitive Function [ Time Frame: Day 1 ]Cogstate computerised cognitive function testing
- Conditioned Pain Modulation [ Time Frame: Day 1 ]Parallel CPM protocol using a heat test stimulus of pain 40
Biospecimen Retention: Samples With DNA
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
|Contact: Andrew SC Rice, Prof||+44 (0)20 3315 email@example.com|
|Contact: Harriet I Wordsworth, Drfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Andrew SC Rice, Prof||Imperial College London|