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（由申请人提供）：高度活跃的抗逆转录病毒疗法（HAART）导致艾滋病毒感染患者的寿命改善，并且50岁以上患者的艾滋病毒感染患病率的增长。一些初步数据表明，老年患者可能对Haart的患者不太反应。具体而言，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HIV感染人群的年龄，越来越需要更好地定义疾病的自然史，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感染的个体进行观察队列研究（1,800名50岁及50岁以上的人和1,800岁以上的50岁以下年龄，在美国的5年HIV初级保健部位之后，在Haart启动年份，Haart CD4和护理人员的地点匹配）。具体目标1：与HAART年轻患者相比，HAART以上50岁以上患者的病毒和免疫反应，HIV疾病进展以及死亡率。我们假设老年患者将获得更高的病毒学抑制率，但免疫反应较少，与年轻患者相比，HIV疾病的进展和死亡率较差。我们的主要研究结果将是HIV疾病进展。次要结果将包括CD4+细胞计数的变化，病毒负荷抑制和死亡。具体目的2：评估不良药物反应（ADR）的发生率，尤其是肝毒性，肾毒性，胰腺炎，糖尿病和脂质异常在老年HIV感染的患者中，由HAART类别分层。我们假设与基于NNRTI的HAART上的HIV+老年患者相比，基于PI的HAART的老年患者需要停止HAART。具体目的3：定义50岁以上HIV感染患者合并症的发病率，患病率和死亡率，特别关注（a）（a）末期肾脏疾病，（b）非HIV相关的恶性肿瘤，（c）贫血和（d）心血管疾病。我们假设老年患者的这些合并症的发生率要比年龄匹配的HIV血清效率对照更大。我们的主要结果将是这些合并症的发生率和流行率。次要结果将包括特定原因死亡率。我们的研究团队拥有艾滋病毒和衰老合作的既定历史，并汇集了艾滋病毒治疗结果，老年人的合并症，新颖的生物统计学和流行病学方法论的大量研究专业知识，在同队研究和纵向分析HIV疾病疾病和AIDS中。