HIV Infections, Memory
Conditions
Keywords
HIV, Neurocognitive function
Brief summary
Despite the advent of highly active antiretroviral therapy (HAART), the prevalence of neurocognitive impairment among HIV-infected patients continues to be an important issue. Although severe forms of AIDS-related dementia have diminished, milder forms of cognitive impairment have been noted among approximately 30% of asymptomatic HIV patients. Studies among HIV-infected U.S. military personnel regarding neurocognitive function have largely been limited to the early 1990s, before the advent of HAART. In these studies subtle neurobehavioral changes were noted among asymptomatic HIV-positive military personnel. This study proposes to determine the prevalence of neurocognitive deficits among HIV-positive military beneficiaries during the era of HAART who are participants of the U.S. Military HIV Natural History Study. The prevalence ascertained in this study will be compared to HIV-negative military beneficiaries who are demographically similar to the HIV positive group. The sample size of the study is to have complete testing on 200 HIV positive and 50 HIV-negative participants; due to the possibility of attrition before study completion, the investigators will enroll up to 300 participants (240 HIV-positive and 60 HIV-negative) to achieve this sample size. The investigators' rates among HIV-positive patients found in this study will also be contextualized in the setting of the prevalence of prior neurocognitive deficits seen in a HIV positive U.S. military population studied in the 1990s, contemporary rates among civilian HIV-infected persons, and normative values in the general HIV-negative population. Compared to other data in the field of neuropsychology, this study is novel in that the HIV population studied is composed largely of HIV patients who have been diagnosed early in their HIV infection; have open, free access to antiretrovirals to begin therapy earlier than most other cohorts; and consists of highly-functioning, educated individuals.
Detailed description
Abbreviations: DOD - U.S. Department of Defense; CD4 - cluster of differentiation 4
Interventions
None listed
Sponsors
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
University of California, San Diego
National Institute of Mental Health (NIMH)
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
HIV Positive Group: Inclusion Criteria: * HIV-infected patients who are 18-50 years of age * Current participants in the U.S. Military HIV Natural History Study (RV168)
Exclusion criteria
* Current suicidal ideation * Inability or unwillingness to complete the full or abbreviated neuropsychological battery and other questionnaires * An acute medical condition that may impact the participant's ability to complete the tests or that may have a significant impact on the test results as deemed by the site research physicians (e.g., pneumonia, influenza); the subject may participate at a later date if the physician deems that the acute medical illness is resolved. HIV Negative Group: Inclusion Criteria: * Between 18 and 50 years of age. * A military beneficiary * HIV negative by an ELISA drawn within one year of study enrollment (or willingness to have HIV test performed which has a negative result)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | within 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 100 |
| HIV-Positive and Late HIV-infection \>6 years of HIV infection since diagnosis, prior AIDS-defining condition, or CD4 count nadir \< 200 cells/mm3 | 100 |
| HIV-negative HIV-negative, control group | 50 |
| Total | 250 |
Baseline characteristics
| Characteristic | HIV-Positive and Early HIV Infection | HIV-Positive and Late HIV-infection | HIV-negative | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 100 Participants | 50 Participants | 250 Participants |
| Age, Continuous | 28.8 years | 42.1 years | 36.0 years | 36.4 years |
| Race/Ethnicity, Customized Black | 27 Participants | 31 Participants | 4 Participants | 62 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants | 11 Participants | 9 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 5 Participants | 12 Participants | 29 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 53 Participants | 25 Participants | 122 Participants |
| Region of Enrollment United States | 100 Participants | 100 Participants | 50 Participants | 250 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 97 Participants | 94 Participants | 48 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 50 |
| other Total, other adverse events | 0 / 100 | 0 / 100 | 0 / 50 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 50 |
Outcome results
Primary
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.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV-Positive-Early | 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 |
| HIV-Positive-Later | 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. | 20 percentage with Impairment |
| HIV-negative | 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. | 30 percentage with Impairment |
p-value: 0.0995% CI: [0.27, 1.1]Regression, Logistic
Secondary
The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas.
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV-Positive-Early | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Recall | 18 Participants |
| HIV-Positive-Early | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Attention/Working Memory | 23 Participants |
| HIV-Positive-Early | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Abstraction Executive Functioning | 19 Participants |
| HIV-Positive-Early | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Learning | 17 Participants |
| HIV-Positive-Early | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Motor Speed & Dexterity | 25 Participants |
| HIV-Positive-Early | 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 |
| HIV-Positive-Early | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Verbal Fluency | 15 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Abstraction Executive Functioning | 19 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Verbal Fluency | 20 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Speed of Information Processing | 7 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Attention/Working Memory | 22 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Learning | 25 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Recall | 19 Participants |
| HIV-Positive-Later | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Motor Speed & Dexterity | 19 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Speed of Information Processing | 3 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Motor Speed & Dexterity | 12 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Recall | 7 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Abstraction Executive Functioning | 12 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Attention/Working Memory | 9 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Verbal Fluency | 11 Participants |
| HIV-negative | The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas. | Learning | 19 Participants |
Comparison: Comparing prevalence of verbal fluency impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.4595% CI: [0.35, 1.61]Regression, Logistic
Comparison: Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.4395% CI: [0.35, 1.56]Regression, Logistic
Comparison: Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.5695% CI: [0.41, 5.17]Regression, Logistic
Comparison: Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.4995% CI: [0.6, 2.93]Regression, Logistic
Comparison: Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.0195% CI: [0.22, 0.84]Regression, Logistic
Comparison: Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.4695% CI: [0.58, 3.34]Regression, Logistic
Comparison: Comparing prevalence of motor speed \& dexterity impairment between HIV-positive and HIV-negative military beneficiariesp-value: 0.7695% CI: [0.43, 1.85]Regression, Logistic