CLINICAL OUTCOMES IN ELDERLY HIV PATIENTS

老年艾滋病毒患者的临床结果

• 批准号: 7163998
• 负责人: KELLY A GEBO
• 金额: $ 11.55万
• 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/7163998
• 关键词: AIDS; HAART (highly active antiretroviral therapy); HIV infections; adult human (21+); anemia; cancer risk; cardiovascular disorder risk; chronic renal failure; clinical research; comorbidity; developmental immunology; drug adverse effect; helper T lymphocyte; hepatitis C; human data; human immunodeficiency virus 1; human middle age (35-64); human mortality; human old age (65+); immune response; immunosenescence; liver toxic disorder; longitudinal human study; pancreatitis; virus load

DESCRIPTION (provided by applicant): 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 observational cohort 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.

描述(申请人提供)：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，并使50岁以上人群中艾滋病毒感染的流行率不断上升。一些初步数据表明，老年患者对HAART的反应可能不如年轻患者。具体地说，免疫恢复可能不太好，老年患者的发病率和死亡率可能更高。随着艾滋病毒感染人群的老龄化，越来越需要更好地确定疾病的自然病史、治疗的有效性以及与年龄相关的合并症对疾病进展的影响。我们建议对3,600名HIV感染者(1,800名50岁及以上和1,800名50岁以下，根据HAART开始的年份、HAART前的CD4和护理地点进行匹配)进行一项观察性队列研究，随后在美国的5个HIV初级保健地点进行。具体目标1：与接受HAART的年轻患者相比，评估接受HAART的50岁以上患者的病毒学和免疫学反应、HIV疾病进展和死亡率。我们假设，与年轻患者相比，年龄较大的患者将实现更高的病毒学抑制率，但免疫反应较弱，艾滋病毒疾病进展和死亡率更差。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。具体目标2：根据HAART分级，评估老年HIV感染患者的不良反应(ADRs)发生率，特别是肝毒性、肾毒性、胰腺炎、糖尿病和血脂异常。我们假设，接受PI为基础的HAART的老年患者将比接受NNRTI为基础的HAART的HIV+老年患者有更多的ADR需要停止HAART。具体目标3：确定50岁以上艾滋病毒感染者的发病率、患病率和死亡率，特别关注(A)终末期肾脏疾病、(B)非艾滋病毒相关恶性肿瘤、(C)贫血和(D)心血管疾病。我们假设，与年龄匹配的HIV血清阴性对照组相比，年龄较大的患者发生这些合并症的几率更高。我们的主要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原因的死亡。我们的研究团队在艾滋病毒和老龄化方面有着既定的合作历史，并在艾滋病毒治疗结果、老年人的共病以及艾滋病毒疾病和艾滋病的队列研究和纵向分析中的新的生物统计学和流行病学方法方面汇集了丰富的研究专业知识。