Trial Outcomes & Findings for Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients (NCT NCT00893815)

Last Updated: 2025-08-28

Results Overview

All participants underwent a comprehensive battery of standardized neuropsychological test and questionnaires that have been shown to be sensitive to HIV-associated neurocognitive disorders. Neuropsychological test were scored by trained psychometrists. Raw scores were converted to demographically adjusted t scores corrected for effects of age, education, gender, and ethnicity. Scores were then converted to deficit scores that give differential weight to impair rather than normal scores. The Global Deficit score was used to summarize neuropsychological test results by quantifying the number and degree of impaired performances. A score of of ≥0.5 has been shown to be a sensitive and specific indicator of global neurocognitive impairment.

Recruitment status

COMPLETED

Target enrollment

250 participants

Primary outcome timeframe

within 30 days

Results posted on

2025-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	HIV-Positive and Early HIV Infection \<6 years of HIV infection since diagnosis, no prior AIDS-defining condition, and CD4 count nadir \> 200 cells/mm3	HIV-Positive and Late HIV-infection \>6 years of HIV infection since diagnosis, prior AIDS-defining condition, or CD4 count nadir \< 200 cells/mm3	HIV-negative HIV-negative, control group
Overall Study STARTED	100	100	50
Overall Study COMPLETED	100	100	50
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV-Positive and Early HIV Infection n=100 Participants \<6 years of HIV infection since diagnosis, no prior AIDS-defining condition, and CD4 count nadir \> 200 cells/mm3	HIV-Positive and Late HIV-infection n=100 Participants \>6 years of HIV infection since diagnosis, prior AIDS-defining condition, or CD4 count nadir \< 200 cells/mm3	HIV-negative n=50 Participants HIV-negative, control group	Total n=250 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	100 Participants n=7 Participants	50 Participants n=5 Participants	250 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	28.8 years n=5 Participants	42.1 years n=7 Participants	36.0 years n=5 Participants	36.4 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	94 Participants n=7 Participants	48 Participants n=5 Participants	239 Participants n=4 Participants
Race/Ethnicity, Customized White	44 Participants n=5 Participants	53 Participants n=7 Participants	25 Participants n=5 Participants	122 Participants n=4 Participants
Race/Ethnicity, Customized Black	27 Participants n=5 Participants	31 Participants n=7 Participants	4 Participants n=5 Participants	62 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	17 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	37 Participants n=4 Participants
Race/Ethnicity, Customized Other	12 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	100 Participants n=5 Participants	100 Participants n=7 Participants	50 Participants n=5 Participants	250 Participants n=4 Participants

PRIMARY outcome

Timeframe: within 30 days

Population: To highlight HIV-positive to HIV-negative comparison, HIV-Positive early and late groups were combined in the paper for statistical analyses. Data are presented here in disaggregated form.

Outcome measures

Outcome measures
Measure	HIV-Positive-Early n=100 Participants Early HIV infection Participants	HIV-Positive-Later n=100 Participants HIV positive later stage group	HIV-negative n=50 Participants HIV-negative, control group
The Prevalence of Neurocognitive Deficits Among HIV-positive Patients as Defined by the Global Deficit Score Based on the Neuropsychological Testing Battery and to Compare This Rate to HIV-negative Military Personnel.	18 percentage with Impairment Interval 10.0 to 26.0	20 percentage with Impairment Interval 12.0 to 28.0	30 percentage with Impairment Interval 17.0 to 43.0

SECONDARY outcome

Timeframe: within 30 days

All participants underwent a comprehensive battery of standardized neuropsychological tests and questionnaires that have been shown to be sensitive to HIV-associated neurocognitive disorders. Neuropsychological tests were scored by trained psychometrists. Raw scores were converted to demographically adjusted t scores corrected for effects of age, education, gender, and ethnicity. Score were then converted to deficit scores that give differential weight to impaired rather than normal scores. The Global Deficit score was used to summarize neuropsychological test results by quantifying the number and degree of impaired performances. A score of ≥0.5 has been shown to be a sensitive and specific indicator of global neurocognitive impairment.

Outcome measures

Outcome measures
Measure	HIV-Positive-Early n=100 Participants Early HIV infection Participants	HIV-Positive-Later n=100 Participants HIV positive later stage group	HIV-negative n=50 Participants HIV-negative, control group
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Verbal Fluency	15 Participants	20 Participants	11 Participants
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Abstraction Executive Functioning	19 Participants	19 Participants	12 Participants
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Speed of Information Processing	10 Participants	7 Participants	3 Participants
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Attention/Working Memory	23 Participants	22 Participants	9 Participants
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Learning	17 Participants	25 Participants	19 Participants
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Recall	18 Participants	19 Participants	7 Participants
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. Motor Speed & Dexterity	25 Participants	19 Participants	12 Participants

Adverse Events

HIV-Positive and Early HIV Infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-Positive and Late HIV-infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-negative

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

Infectious Diseases Clinical Research Program

Henry Jackson Foundation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place