Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study
HIV-POGO
1 other identifier
observational
148
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
March 23, 2021
CompletedMarch 23, 2021
March 1, 2021
4.1 years
July 14, 2015
August 27, 2020
March 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview
Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain
Day 1
Secondary Outcomes (2)
Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set
Day 1
Conditioned Pain Modulation Efficiency
Day 1
Interventions
No intervention - observational only
Eligibility Criteria
Individuals over the age of 18 of any gender with HIV
You may qualify if:
- Aged 18 years or over
- HIV infection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pain Research Group, Dept Surgery & Cancer, Imperial College, Chelsea and Westminster Campus
London, SW10 9NH, United Kingdom
Related Publications (1)
Sipila R, Kemp H, Harno H, Rice ASC, Kalso E. Health-related quality of life and pain interference in two patient cohorts with neuropathic pain: breast cancer survivors and HIV patients. Scand J Pain. 2021 Mar 17;21(3):512-521. doi: 10.1515/sjpain-2020-0177. Print 2021 Jul 27.
PMID: 33725747DERIVED
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Harriet Kemp
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew SC Rice, Prof
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2015
First Posted
September 22, 2015
Study Start
December 1, 2014
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
March 23, 2021
Results First Posted
March 23, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share