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)延长了艾滋病毒感染患者的寿命，并 艾滋病毒在50岁以上人群中的感染率越来越高。一些初步数据表明，年龄较大的 患者对HAART的反应可能不如年轻患者。具体地说，免疫恢复可能会更慢 很好，而且老年患者的发病率和死亡率都可能更高。作为感染艾滋病毒的人群 随着年龄的增长，人们越来越需要更好地定义疾病的自然病史、治疗的有效性以及 年龄相关性合并症对疾病进展的影响。我们建议进行一次观察组 对3,600名艾滋病毒感染者的研究(1,800名50岁及以上和1,800名50岁以下，匹配 在HAART开始的那一年，HAART前的CD4和护理地点)随后在美国的5个艾滋病毒初级保健地点进行 各州。具体目标1：评估病毒学和免疫学反应、艾滋病毒疾病进展和死亡率 接受HAART的50岁以上的患者与接受HAART的年轻患者相比。我们假设年长的病人会 实现更高的病毒学抑制率，但免疫反应较少，并有更严重的艾滋病毒疾病 进展率和死亡率均高于年轻患者。我们的主要研究结果将是艾滋病毒疾病的进展。 次要结果将包括CD4+细胞计数的变化、病毒载量抑制和死亡。特定目标 2：评估药物不良反应(ADRs)发生率，特别是肝毒性、肾毒性、 老年HIV感染患者中的胰腺炎、糖尿病和血脂异常，按HAART分级。我们 假设接受基于PI的HAART的老年患者比需要停止HAART的ADR患者更多 HIV+老年患者接受基于NNRTI的HAART。具体目标3：确定以下疾病的发病率、流行率和死亡率 50岁以上艾滋病毒感染者的合并症，特别关注(A)终末期肾病，(B) 与艾滋病毒无关的恶性肿瘤，(C)贫血和(D)心血管疾病。我们假设年长的病人 与年龄匹配的HIV血清阴性对照组相比，这些合并症的发生率更高。我们的初选 结果将是这些并存疾病的发生率和流行率。次要结果将包括 特定死因死亡。我们的研究团队在艾滋病毒和老龄化方面有既定的合作历史，并且 汇集了在艾滋病毒治疗结果、老年人并存疾病以及 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。