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Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences

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ClinicalTrials.gov Identifier: NCT00675766
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition HIV Infections
Enrollment 223
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description HIV-positive adults 50 and older HIV-positive adults 18-40 years old HIV-negative controls 50 and older HIV-negative controls 18-40 years old
Period Title: Overall Study
Started 106 30 50 37
Year 2 105 28 34 20
Year 3 100 25 29 11
Completed 100 25 29 11
Not Completed 6 5 21 26
Reason Not Completed
Lost to Follow-up             6             5             21             26
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group Description HIV-positive adults 50 and older HIV-positive adults 18-40 years old HIV-negative controls 50 and older HIV-negative controls 18-40 years old Total of all reporting groups
Overall Number of Baseline Participants 106 30 50 37 223
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 30 participants 50 participants 37 participants 223 participants
Between 18 and 40 years old 0 30 0 37 67
50 years and older 106 0 50 0 156
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 30 participants 50 participants 37 participants 223 participants
Female
18
  17.0%
6
  20.0%
32
  64.0%
17
  45.9%
73
  32.7%
Male
88
  83.0%
24
  80.0%
18
  36.0%
20
  54.1%
150
  67.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 30 participants 50 participants 37 participants 223 participants
American Indian or Alaska Native
2
   1.9%
0
   0.0%
2
   4.0%
0
   0.0%
4
   1.8%
Asian
1
   0.9%
1
   3.3%
1
   2.0%
3
   8.1%
6
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
59
  55.7%
12
  40.0%
36
  72.0%
16
  43.2%
123
  55.2%
White
43
  40.6%
15
  50.0%
9
  18.0%
12
  32.4%
79
  35.4%
More than one race
1
   0.9%
2
   6.7%
2
   4.0%
6
  16.2%
11
   4.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 30 participants 50 participants 37 participants 223 participants
106 30 50 37 223
1.Primary Outcome
Title Neuropsychological Status (i.e., Cognitive Functioning)
Hide Description 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.
Time Frame Baseline (Year 1) and 1-year follow-up (Year 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
HIV-positive adults 50 and older
HIV-positive adults 18-40 years old
HIV-negative controls 50 and older
HIV-negative controls 18-40 years old
Overall Number of Participants Analyzed 67 16 15 5
Mean (Standard Error)
Unit of Measure: z-score composites of cognitive domains
Baseline z-score global neurocognitive composite 0.008  (.066) .484  (.134) -.084  (.157) -.482  (.301)
Year 2 z-score global neurocognitive composite -.091  (.066) .517  (.134) -.036  (.157) .397  (.300)
Baseline z-score for language 0.056  (0.762) 0.468  (0.520) -.075  (.480) -.112  (.835)
Year 2 z-score for language 0.014  (.840) .413  (.773) -.088  (.680) .385  (.605)
Baseline z-score for learning/memory -.034  (.875) .540  (.618) -.287  (.552) .277  (1.338)
Year 2 z-score for learning/memory -.145  (.832) .493  (.689) -.126  (.884) .360  (.630)
Baseline z-score for attention .035  (.870) .215  (.681) .070  (.816) -.190  (1.396)
Year 2 z-score for attention -.026  (.816) .366  (.654) -.199  (.863) .706  (.435)
Baseline z-score for processing speed -.043  (.729) .602  (.469) -.301  (.552) -.241  (.831)
Year 2 z-score for processing speed -.167  (.726) .600  (.761) -.422  (.699) .586  (.496)
Baseline z-score for executive function -.047  (.417) .331  (.397) -.221  (.564) -.318  (.832)
Year 2 z-score for executive function -.052  (.843) .292  (.360) -.070  (.484) -.029  (.086)
Baseline z-score for visuospatial function -.020  (.923) .801  (1.013) -.163  (.788) .450  (.975)
Year 2 z-score for visuospatial function -.144  (.892) .859  (.820) -.153  (.927) .821  (.485)
Baseline z-score for motor speed .009  (.862) .516  (.632) -.356  (.993) -.091  (.836)
Year 2 z-score for motor speed .093  (.817) -.515  (.411) .177  (.696) -.446  (.371)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.01
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.07
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .72
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2, Group 3, Group 4
Comments Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Repeated Measures ANOVA
Comments Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .044
Comments [Not Specified]
Method Fisher Exact
Comments One-sided Fisher's exact test with 1 degree of freedom.
Time Frame Adverse event data was collected for up to 4 years after each subject's baseline visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description HIV-positive adults 50 and older HIV-positive adults 18-40 years old HIV-negative controls 50 and older HIV-negative controls 18-40 years old
All-Cause Mortality
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/30 (0.00%)   0/50 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/30 (0.00%)   0/50 (0.00%)   0/37 (0.00%) 
Large number of subjects who were lost to follow up (i.e moved from community, did not answer follow up calls to schedule visits) resulted in a reduced sample size of subjects who completed the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Charles Hinkin
Organization: West Los Angeles Veterans Association
Phone: 310-478-3711 ext 44214
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00675766     History of Changes
Other Study ID Numbers: AGCG-012-04F
First Submitted: May 7, 2008
First Posted: May 12, 2008
Results First Submitted: February 13, 2015
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015