Trial Outcomes & Findings for Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences (NCT NCT00675766)

Last Updated: 2015-05-04

Results Overview

Neurocognitive functions refer to cognitive abilities, namely learning/memory, motor speed, psychomotor speed, language, attention, visuospatial abilities, \& executive function. They are measured using standard clinical neuropsychological test battery that included: HVLT, BVMT-R, Trails A \& B, WCST-64, WAIS-Symbol Search/Digit Coding/Letter-Number Sequencing/Block Design, FAS, \& Animals. Subgroups of these tasks were combined to create composite scores indicating participants' score on each cognitive domains. To make these cognitive domain composite scores, each participant's raw score on each of these tests was converted into a within-sample standardized score (i.e., z-score), which are normally distributed with a mean of 0 \& SD of 1. Then, these standardized scores were summed to create composite scores for each cognitive domain and then averaged to create a global neuropsychological function composite score. A positive composite score represents a better outcome for all variables.

Recruitment status

COMPLETED

Target enrollment

223 participants

Primary outcome timeframe

Baseline (Year 1) and 1-year follow-up (Year 2)

Results posted on

2015-05-04

Participant Flow

Recruitment took place from September 2005 to September 2010. The population consisted of young (40 years or less) and old (50 years or more) Human Immunodeficiency Virus infected and non-infected veterans within the Greater Los Angeles VA Healthcare System with additional recruitment from the Los Angeles community in order to meet project goals.

Recruited subjects who meet any of the following criteria were excluded prior to group assignment: Brain infection other than HIV; Brain neoplasm; neurosyphilis; traumatic brain injury with L.O.C\>30 mins; current diagnosis of seizure disorder; current psychotic spectrum disorders; history of drug or alcohol abuse or dependence within the past year.

Participant milestones

Participant milestones
Measure	Group 1 HIV-positive adults 50 and older	Group 2 HIV-positive adults 18-40 years old	Group 3 HIV-negative controls 50 and older	Group 4 HIV-negative controls 18-40 years old
Overall Study STARTED	106	30	50	37
Overall Study Year 2	105	28	34	20
Overall Study Year 3	100	25	29	11
Overall Study COMPLETED	100	25	29	11
Overall Study NOT COMPLETED	6	5	21	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 HIV-positive adults 50 and older	Group 2 HIV-positive adults 18-40 years old	Group 3 HIV-negative controls 50 and older	Group 4 HIV-negative controls 18-40 years old
Overall Study Lost to Follow-up	6	5	21	26

Baseline Characteristics

Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=106 Participants HIV-positive adults 50 and older	Group 2 n=30 Participants HIV-positive adults 18-40 years old	Group 3 n=50 Participants HIV-negative controls 50 and older	Group 4 n=37 Participants HIV-negative controls 18-40 years old	Total n=223 Participants Total of all reporting groups
Age, Customized Between 18 and 40 years old	0 participants n=5 Participants	30 participants n=7 Participants	0 participants n=5 Participants	37 participants n=4 Participants	67 participants n=21 Participants
Age, Customized 50 years and older	106 participants n=5 Participants	0 participants n=7 Participants	50 participants n=5 Participants	0 participants n=4 Participants	156 participants n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	6 Participants n=7 Participants	32 Participants n=5 Participants	17 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	24 Participants n=7 Participants	18 Participants n=5 Participants	20 Participants n=4 Participants	150 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	59 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants	16 Participants n=4 Participants	123 Participants n=21 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	12 Participants n=4 Participants	79 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	106 participants n=5 Participants	30 participants n=7 Participants	50 participants n=5 Participants	37 participants n=4 Participants	223 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (Year 1) and 1-year follow-up (Year 2)

Population: HIV+ and HIV negative men who were evaluated BOTH at baseline and Year 2. Those participants who were evaluated at Baseline but not at Year 2 were excluded from analyses.

Outcome measures

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Charles Hinkin

West Los Angeles Veterans Association

Phone: 310-478-3711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 n=67 Participants HIV-positive adults 50 and older	Group 2 n=16 Participants HIV-positive adults 18-40 years old	Group 3 n=15 Participants HIV-negative controls 50 and older	Group 4 n=5 Participants HIV-negative controls 18-40 years old
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score global neurocognitive composite	0.008 z-score composites of cognitive domains Standard Error .066	.484 z-score composites of cognitive domains Standard Error .134	-.084 z-score composites of cognitive domains Standard Error .157	-.482 z-score composites of cognitive domains Standard Error .301
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score global neurocognitive composite	-.091 z-score composites of cognitive domains Standard Error .066	.517 z-score composites of cognitive domains Standard Error .134	-.036 z-score composites of cognitive domains Standard Error .157	.397 z-score composites of cognitive domains Standard Error .300
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for language	0.056 z-score composites of cognitive domains Standard Error 0.762	0.468 z-score composites of cognitive domains Standard Error 0.520	-.075 z-score composites of cognitive domains Standard Error .480	-.112 z-score composites of cognitive domains Standard Error .835
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for language	0.014 z-score composites of cognitive domains Standard Error .840	.413 z-score composites of cognitive domains Standard Error .773	-.088 z-score composites of cognitive domains Standard Error .680	.385 z-score composites of cognitive domains Standard Error .605
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for learning/memory	-.034 z-score composites of cognitive domains Standard Error .875	.540 z-score composites of cognitive domains Standard Error .618	-.287 z-score composites of cognitive domains Standard Error .552	.277 z-score composites of cognitive domains Standard Error 1.338
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for learning/memory	-.145 z-score composites of cognitive domains Standard Error .832	.493 z-score composites of cognitive domains Standard Error .689	-.126 z-score composites of cognitive domains Standard Error .884	.360 z-score composites of cognitive domains Standard Error .630
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for attention	.035 z-score composites of cognitive domains Standard Error .870	.215 z-score composites of cognitive domains Standard Error .681	.070 z-score composites of cognitive domains Standard Error .816	-.190 z-score composites of cognitive domains Standard Error 1.396
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for attention	-.026 z-score composites of cognitive domains Standard Error .816	.366 z-score composites of cognitive domains Standard Error .654	-.199 z-score composites of cognitive domains Standard Error .863	.706 z-score composites of cognitive domains Standard Error .435
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for processing speed	-.043 z-score composites of cognitive domains Standard Error .729	.602 z-score composites of cognitive domains Standard Error .469	-.301 z-score composites of cognitive domains Standard Error .552	-.241 z-score composites of cognitive domains Standard Error .831
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for processing speed	-.167 z-score composites of cognitive domains Standard Error .726	.600 z-score composites of cognitive domains Standard Error .761	-.422 z-score composites of cognitive domains Standard Error .699	.586 z-score composites of cognitive domains Standard Error .496
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for executive function	-.047 z-score composites of cognitive domains Standard Error .417	.331 z-score composites of cognitive domains Standard Error .397	-.221 z-score composites of cognitive domains Standard Error .564	-.318 z-score composites of cognitive domains Standard Error .832
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for executive function	-.052 z-score composites of cognitive domains Standard Error .843	.292 z-score composites of cognitive domains Standard Error .360	-.070 z-score composites of cognitive domains Standard Error .484	-.029 z-score composites of cognitive domains Standard Error .086
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for visuospatial function	-.020 z-score composites of cognitive domains Standard Error .923	.801 z-score composites of cognitive domains Standard Error 1.013	-.163 z-score composites of cognitive domains Standard Error .788	.450 z-score composites of cognitive domains Standard Error .975
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for visuospatial function	-.144 z-score composites of cognitive domains Standard Error .892	.859 z-score composites of cognitive domains Standard Error .820	-.153 z-score composites of cognitive domains Standard Error .927	.821 z-score composites of cognitive domains Standard Error .485
Neuropsychological Status (i.e., Cognitive Functioning) Baseline z-score for motor speed	.009 z-score composites of cognitive domains Standard Error .862	.516 z-score composites of cognitive domains Standard Error .632	-.356 z-score composites of cognitive domains Standard Error .993	-.091 z-score composites of cognitive domains Standard Error .836
Neuropsychological Status (i.e., Cognitive Functioning) Year 2 z-score for motor speed	.093 z-score composites of cognitive domains Standard Error .817	-.515 z-score composites of cognitive domains Standard Error .411	.177 z-score composites of cognitive domains Standard Error .696	-.446 z-score composites of cognitive domains Standard Error .371