- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02555930
Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study (HIV-POGO)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige, SW10 9NH
- Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview
Tidsramme: Day 1
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Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain
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Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set
Tidsramme: Day 1
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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.
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Day 1
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Conditioned Pain Modulation Efficiency
Tidsramme: Day 1
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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.
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Day 1
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Andrew SC Rice, Prof, Imperial College London
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14/LO/1574
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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