Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study (HIV-POGO)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido, SW10 9NH
- Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew SC Rice, Prof, Imperial College London
Publicaciones y enlaces útiles
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
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Palabras clave
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Otros números de identificación del estudio
- 14/LO/1574
Plan de datos de participantes individuales (IPD)
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