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| ID | Type | Description | Link |
|---|---|---|---|
| Y1-AI-5072 | Other Grant/Funding Number | NIAID Interagency Agreement | |
| P30MH062512 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Infectious Diseases Clinical Research Program | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| University of California, San Diego | OTHER |
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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.
Abbreviations:
DOD - U.S. Department of Defense; CD4 - cluster of differentiation 4
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | HIV-Positive and Early HIV infection (<6 years of HIV infection since diagnosis [based on DoD standard testing], no prior AIDS-defining condition, and CD4 nadir >200 cells/mm3) | ||
| 2 | HIV-Positive and Late HIV-infection (HIV infected, not meeting all 3 criteria) | ||
| 3 | HIV-negative (HIV uninfected based on DoD standard testing) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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HIV Positive Group:
Inclusion Criteria:
Exclusion Criteria:
HIV Negative Group:
Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of 50 HIV-negative patients and at least 200 HIV-positive patients who are 18-50 years of age and current participants of "A Retrospective and Prospective Observational Study of the Natural History of HIV Infection in Active Duty U.S. Military Personnel and Department of Defense Beneficiaries"(RV168).
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| Name | Affiliation | Role |
|---|---|---|
| Brian K Agan, MD | Infectious Disease Clinical Research Program (IDCRP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| Walter Reed National Military Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23144815 | Result | Moore DJ, Roediger MJ, Eberly LE, Blackstone K, Hale B, Weintrob A, Ganesan A, Agan BK, Letendre SL, Crum-Cianflone NF. Identification of an abbreviated test battery for detection of HIV-associated neurocognitive impairment in an early-managed HIV-infected cohort. PLoS One. 2012;7(11):e47310. doi: 10.1371/journal.pone.0047310. Epub 2012 Nov 8. | |
| 23303852 | Result | Crum-Cianflone NF, Moore DJ, Letendre S, Poehlman Roediger M, Eberly L, Weintrob A, Ganesan A, Johnson E, Del Rosario R, Agan BK, Hale BR. Low prevalence of neurocognitive impairment in early diagnosed and managed HIV-infected persons. Neurology. 2013 Jan 22;80(4):371-9. doi: 10.1212/WNL.0b013e31827f0776. Epub 2013 Jan 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | HIV-Positive and Late HIV-infection | >6 years of HIV infection since diagnosis, prior AIDS-defining condition, or CD4 count nadir < 200 cells/mm3 |
| FG002 | HIV-negative | HIV-negative, control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | HIV-Positive and Late HIV-infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage with Impairment | within 30 days |
Adverse events were reviewed during active participation in the study (30 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Infectious Diseases Clinical Research Program | Henry Jackson Foundation | contactus@idcrp.org |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| National Institute of Mental Health (NIMH) |
| NIH |
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| within 30 days |
| Bethesda |
| Maryland |
| 20889 |
| United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| 22431801 | Result | Crum-Cianflone NF, Roediger MP, Moore DJ, Hale B, Weintrob A, Ganesan A, Eberly LE, Johnson E, Agan BK, Letendre S. Prevalence and factors associated with sleep disturbances among early-treated HIV-infected persons. Clin Infect Dis. 2012 May;54(10):1485-94. doi: 10.1093/cid/cis192. Epub 2012 Mar 19. |
>6 years of HIV infection since diagnosis, prior AIDS-defining condition, or CD4 count nadir < 200 cells/mm3
| BG002 | HIV-negative | HIV-negative, control group |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | HIV-Positive-Early | Early HIV infection Participants |
| OG001 | HIV-Positive-Later | HIV positive later stage group |
| OG002 | HIV-negative | HIV-negative, control group |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | within 30 days |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | HIV-Positive and Late HIV-infection | >6 years of HIV infection since diagnosis, prior AIDS-defining condition, and CD4 count nadir < 200 cells/mm3 | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | HIV-negative | HIV-negative, control group | 0 | 50 | 0 | 50 | 0 | 50 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Speed of Information Processing |
|
| Attention/Working Memory |
|
| Learning |
|
| Recall |
|
| Motor Speed & Dexterity |
|
Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiaries |
| Regression, Logistic |
| 0.43 |
Threshold for statistical significance: 0.05 |
| Odds Ratio (OR) |
| 0.74 |
| 2-Sided |
| 95 |
| 0.35 |
| 1.56 |
HIV-positive / HIV-negative |
| Other |
| Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiaries | Regression, Logistic | 0.56 | Threshold for statistical significance: 0.05 | Odds Ratio (OR) | 1.45 | 2-Sided | 95 | 0.41 | 5.17 | HIV-positive / HIV-negative | Other |
| Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiaries | Regression, Logistic | 0.49 | Threshold for statistical significance: 0.05 | Odds Ratio (OR) | 1.32 | 2-Sided | 95 | 0.60 | 2.93 | HIV-positive / HIV-negative | Other |
| Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiaries | Regression, Logistic | 0.01 | Threshold for statistical significance: 0.05 | Odds Ratio (OR) | 0.43 | 2-Sided | 95 | 0.22 | 0.84 | HIV-positive / HIV-negative | Other |
| Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiaries | Regression, Logistic | 0.46 | Threshold for statistical significance: 0.05 | Odds Ratio (OR) | 1.39 | 2-Sided | 95 | 0.58 | 3.34 | HIV-positive / HIV-negative | Other |
| Comparing prevalence of motor speed & dexterity impairment between HIV-positive and HIV-negative military beneficiaries | Regression, Logistic | 0.76 | Threshold for statistical significance: 0.05 | Odds Ratio (OR) | 0.89 | 2-Sided | 95 | 0.43 | 1.85 | HIV-positive / HIV-negative | Other |