Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 3
- 主要终点
- Assess the prevalence of co-morbidities and multimorbidity between HIV-positive patients with similar duration of HIV infection, but 30 years difference
研究概览
简要总结
Clinical hypotheses:
The increasing number of people aging with HIV is a matter of fact. Differences in prevalence of comorbidities between the general population and HIV-positive patients are mainly driven by duration of HIV infection rather than chronological age of HIV+ patients.
People aging with HIV display heterogeneous health conditions. Host factors and duration of HIV infection are associated with increased risk of MM, independently from chronological age and these factors are responsible of the prevalence difference of comorbidities and MM in comparison to the general population.
Objectives:
The study objective is to assess the prevalence of, and risk factors for, individual co-morbidities and multi morbidity (MM) between HIV-positive patients with similar duration of HIV infection, but 30 years difference. We compared estimates across both groups to a matched community-based cohort sampled from the general population.
详细描述
This study is a case-control study, including antiretroviral therapy (ART)-experienced patients, coming from the two following cohorts:
- Modena HIV Metabolic Clinic (MHMC) cohort and
- Romanian HIV cohort (RHC). For this study only patients living with HIV ≥ 20 years will belong to these two cohort. The Aging-Young patients acquired HIV infection in childhood, and Aging-old patients acquired HIV infection above the age of 30.
Aging-Young patients will be matched to Aging-Old patients considering gender and HIV duration (within 1 year interval) (This is the most important matching criteria. The exact number of year of HIV duration since HIV test is the major criteria). An HIV negative test within 5 years prior HIV diagnosis is required in the selection of patients from MHMC to avoid an unpredicted HIV time exposure in these patients.
Then, Aging-young and Aging-old patients will be age, gender matched with a 1: 3 ratio with CINECA (Consorzio Interuniversitario di Calcolo) "ARNO" records (control group, called "HIV-negative group"). The study will analyse 200 HIV Aging-Young and 200 HIV Aging-Old patients in comparison to 1200 controls.
In the first set of analyses, the prevalence of non-infectious comorbidities (NICM) and multimorbidities (MM) in HIV Aging-Young and in HIV Aging-Old groups will be compared to those of HIV-negative group using multivariable logistic regression models. In the second set of analyses, the probability of MM in the HIV Aging-Young cohort will be compared to the HIV Aging-Old one, using multivariable logistic regression models.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV Aging-Old patients will be selected at Modena HIV metabolic Clinic. 200 consecutive patients who satisfy the following criteria:
- •HIV + since 20 year
- •HIV diagnosis occurred when the patient was older than 30 years
- •HIV negative test within 5 years prior HIV diagnosis
- •Multidisciplinary evaluation for comorbidities was performed during 2014
- •On HAART for at least 1 year
- •HIV Aging-Young patients will be selected at Romanian HIV Cohort. 200 consecutive patients who satisfy the following criteria:
- •HIV + since 20 year
- •HIV diagnosis occurred when the patient was younger than 5 years
- •Multidisciplinary evaluation for comorbidities was performed during 2014
- •On HAART for at least 1 year
排除标准
- •Not Applicable
结局指标
主要结局
Assess the prevalence of co-morbidities and multimorbidity between HIV-positive patients with similar duration of HIV infection, but 30 years difference
时间窗: 1 year
Multimorbidity is assessed by physician based on the concurrent presence of \> 2 non infectious comorbidities (hypertension, cardiovascular disease, diabetes, etc)
次要结局
未报告次要终点
研究者
Giovanni Guaraldi
MD
University of Modena and Reggio Emilia