Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Abbreviations:
DOD - U.S. Department of Defense; CD4 - cluster of differentiation 4
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-infected patients who are 18-50 years of age
- •Current participants in the U.S. Military HIV Natural History Study (RV168)
排除标准
- •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)
- •Exclusion Criteria:
- •Inability or unwillingness to complete the full or abbreviated neuropsychological battery and other questionnaires
- •Presence of current suicidal thoughts
- •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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- The Prevalence of Neurocognitive Impairment Among HIV-positive Compared to HIV-negative Military Beneficiaries in Seven Major Ability Areas.(within 30 days)