CLINICAL OUTCOMES IN ELDERLY HIV PATIENTS

老年艾滋病毒患者的临床结果

• 批准号: 7471106
• 负责人: KELLY A GEBO
• 金额: $ 8.2万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7471106
• 关键词: Acquired Immunodeficiency Syndrome; Acute; Age; Anemia; Anti-Retroviral Agents; CD4 Lymphocyte Count; Cardiovascular Diseases; Caring; Cessation of life; Class; Clinical; Cohort Studies; Collaborations; Comorbidity; Controlled Study; Data; Diabetes Mellitus; Disease; Disease Progression; Dyslipidemias; Effectiveness; Elderly; End stage renal failure; Glucose; HIV; HIV Infections; Hepatotoxicity; Highly Active Antiretroviral Therapy; Hyperglycemia; Immune; Immune response; Immunologics; Incidence; Individual; Infection; Lipids; Liver diseases; Longevity; Longitudinal Studies; Malignant Neoplasms; Methodology; Morbidity - disease rate; Natural History; Numbers; Outcome; Outcome Study; Pancreatitis; Patients; Pharmaceutical Preparations; Population; Prevalence; Primary Health Care; Primary carcinoma of the liver cells; Rate; Reaction; Recording of previous events; Recovery; Research; Research Personnel; Risk; Site; Staging; Toxic effect; Treatment Protocols; Treatment outcome; United States; Viral; Viral Load result; Viral hepatitis; age related; antiretroviral therapy; base; cardiovascular disorder risk; cohort; disease natural history; improved; mortality; nephrotoxicity; non-nucleoside reverse transcriptase inhibitors; novel; older patient; programs; response

Highly active antiretroviral therapy (HAART) has resulted in improved longevity in HIV-infected patients and a growing prevalence of HIV infection in people over the age of 50. Some preliminary data suggest that older patients may not respond as well to HAART as younger patients. Specifically, immune recovery may be less good, and both morbidity and mortality rates may be higher in older patients. As the HIV-infected population ages, there is a growing need to better define the natural history of the disease, the effectiveness of therapy, and the effect of age-related comorbidities on disease progression. We propose to conduct an observationalcohort study of 3,600 HIV-infected individuals (1,800 aged 50 years and over and 1,800 under age 50 years, matched on year of HAART initiation, pre-HAART CD4, and site of care) followed at 5 HIV primary care sites in the United States. Specific aim 1: evaluate virologic and immunologic response, HIV disease progression, and mortality in patients over 50 on HAART compared to younger patients on HAART. We hypothesize that older patients will achieve greater rates of virologic suppression, but less immunologic response and have worse HIV disease progression and mortality than younger patients. Our primary study outcome will be HIV disease progression. Secondary outcomes will include changes in CD4+ cell counts, viral load suppression, and death. Specific Aim 2: evaluate the incidence of adverse drug reactions (ADRs), particularly hepatotoxicity, nephrotoxicity, pancreatitis, diabetes, and lipid abnormalities in older HIV-infected patients, stratified by HAART class. We hypothesize that older patients on PI based HAART will have more ADR's requiring cessation of HAART than HIV+ older patients on NNRTI based HAART. Specific Aim 3: define incidence, prevalence, and mortality from comorbidities in HIV-infected patients over age 50 with a particular focus on (a) end-stage renal disease, (b) non-HIV related malignancies, (c) anemia and (d) cardiovascular disease. We hypothesize that older patients will have a greater incidence of these comorbidities than age matched HIV seronegative controls. Our primary outcomes will be incidence and prevalence of these comorbidities. Secondary outcomes will include cause-specific mortality. Our research team has an established history of collaboration in HIV and aging, and brings together a wealth of research expertise in HIV treatment outcomes, co-morbidities in the elderly, and novel biostatistical and epidemiological methodologies in cohort studies and longitudinal analyses of HIV disease and AIDS.

高效抗逆转录病毒疗法（HAART）已导致艾滋病毒感染患者的寿命延长， 50岁以上人群中艾滋病毒感染率不断上升。一些初步数据显示， 患者可能对HAART的反应不如年轻患者。具体来说，免疫恢复可能更少 良好，老年患者的发病率和死亡率可能更高。由于艾滋病毒感染者 随着年龄的增长，越来越需要更好地定义疾病的自然史，治疗的有效性， 年龄相关合并症对疾病进展的影响。我们建议在一个月内 对3，600名艾滋病毒感染者（1，800名年龄在50岁以上，1，800名年龄在50岁以下， 在美国的5个HIV初级保健中心， States.具体目标1：评估艾滋病患者的病毒学和免疫学应答、HIV疾病进展和死亡率， 50岁以上的HAART患者与年轻患者相比。我们假设老年患者 达到更高的病毒学抑制率，但免疫反应更少，艾滋病更严重 与年轻患者相比，我们的主要研究结果将是HIV疾病进展。 次要结局将包括CD4+细胞计数、病毒载量抑制和死亡的变化。具体目标 2：评价药物不良反应（ADR）的发生率，特别是肝毒性、肾毒性， 胰腺炎、糖尿病和血脂异常的老年HIV感染患者，按HAART分类分层。我们 假设接受基于PI的HAART治疗的老年患者发生的需要停止HAART的ADR比 接受基于NNRTI的HAART的HIV+老年患者。具体目标3：定义发病率、患病率和死亡率， 50岁以上HIV感染患者的合并症，特别关注（a）终末期肾病，（B） 非HIV相关的恶性肿瘤，（c）贫血和（d）心血管疾病。我们假设老年患者 这些合并症的发生率高于年龄匹配的HIV血清阴性对照。我们的首要 结果将是这些合并症的发生率和患病率。次要结局将包括 死因特异性死亡率我们的研究团队在艾滋病毒和衰老方面有着悠久的合作历史， 汇集了丰富的研究专业知识，艾滋病毒治疗结果，老年人的共病， 艾滋病毒疾病队列研究和纵向分析中的新生物统计学和流行病学方法 和艾滋病