Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark

Copenhagen comorbidity in HIV infection (COCOMO) study: a study protocol for a longitudinal, non-interventional assessment of non-AIDS comorbidity in HIV infection in Denmark
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DOI:
10.1186/s12879-016-2026-9
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发表时间:
2016-11-26
影响因子:
3.7
通讯作者:
Nielsen, Susanne Dam
Nielsen, Susanne Dam
中科院分区:
医学3区
文献类型:
--
作者:
Ronit, Andreas;Haissman, Judith;Nielsen, Susanne Dam

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背景:现代联合抗逆转录病毒疗法(cART)改善了艾滋病毒感染者(PLWHIV)的生存率。非艾滋病合并症已取代机会性感染,成为死亡和发病的主要原因,并正在成为一个关键的健康问题,因为这一人群继续老龄化。本研究的目的是评估在cART时代丹麦的PLWHIV患者中非AIDS合并症的患病率和发生率,并确定致病的危险因素。该研究主要针对心血管,呼吸道,肝脏非艾滋病comormorphis.Methods/设计:哥本哈根艾滋病感染(COCOMO)研究是一项观察性,纵向队列研究。该研究于2015年启动,招募工作正在进行中,目的是纳入哥本哈根地区的1500名艾滋病毒携带者。计划在2年和10年后进行随访检查。未感染的对照来自哥本哈根一般人群研究(CGPS),这是一项包括来自同一地理区域的100,000名未感染参与者的队列研究。从COCOMO研究和CGPS的参与者中统一收集生理和生物学指标,包括血压、踝臂指数、心电图、肺活量测定、呼出一氧化氮、肝脏瞬时弹性成像、心脏计算机断层扫描(CT)血管造影、胸部和上腹部的非增强CT以及许多常规生化分析。将血浆、血清、血沉棕黄层、外周血单核细胞(PBMC)、尿液和粪便样品收集在生物库中用于未来研究。数据将通过定期链接到国家databases.Discussion更新:随着PLWHIV预期寿命的提高,研究HIV和cART的长期影响至关重要。我们预计,这项队列研究的结果将增加对PLWHIV非艾滋病合并症的认识,并为未来的干预性试验确定目标。认识到PLWHIV合并症的人口统计学、临床和病理生理学特征可能有助于制定新的指南,并使我们能够向前迈进,提供更加个性化的艾滋病毒护理。
Background: Modern combination antiretroviral therapy (cART) has improved survival for people living with HIV (PLWHIV). Non-AIDS comorbidities have replaced opportunistic infections as leading causes of mortality and morbidity, and are becoming a key health concern as this population continues to age. The aim of this study is to estimate the prevalence and incidence of non-AIDS comorbidity among PLWHIV in Denmark in the cART era and to determine risk factors contributing to the pathogenesis. The study primarily targets cardiovascular, respiratory, and hepatic non-AIDS comorbidity.Methods/design: The Copenhagen comorbidity in HIV-infection (COCOMO) study is an observational, longitudinal cohort study. The study was initiated in 2015 and recruitment is ongoing with the aim of including 1500 PLWHIV from the Copenhagen area. Follow-up examinations after 2 and 10 years are planned. Uninfected controls are derived from the Copenhagen General Population Study (CGPS), a cohort study including 100,000 uninfected participants from the same geographical region. Physiological and biological measures including blood pressure, ankle-brachial index, electrocardiogram, spirometry, exhaled nitric oxide, transient elastography of the liver, computed tomography (CT) angiography of the heart, unenhanced CT of the chest and upper abdomen, and a number of routine biochemical analysis are uniformly collected in participants from the COCOMO study and the CGPS. Plasma, serum, buffy coat, peripheral blood mononuclear cells (PBMC), urine, and stool samples are collected in a biobank for future studies. Data will be updated through periodical linking to national databases.Discussion: As life expectancy for PLWHIV improves, it is essential to study long-term impact of HIV and cART. We anticipate that findings from this cohort study will increase knowledge on non-AIDS comorbidity in PLWHIV and identify targets for future interventional trials. Recognizing the demographic, clinical and pathophysiological characteristics of comorbidity in PLWHIV may help inform development of new guidelines and enable us to move forward to a more personalized HIV care.