Trial Outcomes & Findings for Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study (NCT NCT02555930)
NCT ID: NCT02555930
Last Updated: 2021-03-23
Results Overview
Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain
COMPLETED
148 participants
Day 1
2021-03-23
Participant Flow
NA all recruited were included
Participant milestones
| Measure |
Total Cohort
Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy and/or neuropathic pain)
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
COMPLETED
|
148
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study
Baseline characteristics by cohort
| Measure |
Total Cohort
n=148 Participants
Observational study whole cohort - Adults with HIV infection (with or without sensory neuropathy or neuropathic pain)
|
|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
|
Employment
Employed
|
79 Participants
n=5 Participants
|
|
Employment
Not working through illness
|
41 Participants
n=5 Participants
|
|
Employment
Unemployed
|
10 Participants
n=5 Participants
|
|
Employment
Retired
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Adults with HIV infection
Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain
Outcome measures
| Measure |
Total Cohort
n=148 Participants
Whole cohort - Adults with HIV infection
|
|---|---|
|
Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview
DN4 >3
|
81 Participants
|
|
Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview
DN4 <4
|
67 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: All participants that completed Cogstate cognitive function testing
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.
Outcome measures
| Measure |
Total Cohort
n=140 Participants
Whole cohort - Adults with HIV infection
|
|---|---|
|
Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set
|
48.09 T-score for global measure of function
Standard Deviation 8.07
|
SECONDARY outcome
Timeframe: Day 1Population: All subjects who completed full Conditioned Pain Modulation protocol
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.
Outcome measures
| Measure |
Total Cohort
n=63 Participants
Whole cohort - Adults with HIV infection
|
|---|---|
|
Conditioned Pain Modulation Efficiency
|
0.78 kPa
Standard Deviation 0.80
|
Adverse Events
Total Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place