Epidemiological Study of the Markers of Aging in the Cohort of Patient HIV in Brest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- liver aging
研究概览
简要总结
RATIONALE: HIV pathology has been associated with accelerated aging of the infected organism, with no known knowledge of virus, immunosuppression, immune response stimulation, antiretroviral toxicity, and "classic" risks. The data are in good standing from a multicenter cohort with high statistical power but very heterogeneous and not exhaustive. A complementary approach by small, comprehensive cohorts is desirable.
POPULATION CONCERNED: HIV-positive persons OBJECTIVE To describe the aging of the physiological functions of people living with HIV.
SECONDARY OBJECTIVES Assess the determinants (virus / HAART / Immunity / environment) Compare to the general population (historical comparisons) Compare to main body functions MAIN EVALUATION CRITERIA respiratory functional tests, memory test, IMTc, ECG, creatininemia, cancer, Fibroscan, bone densitometry...
SECONDARY EVALUATION CRITERIA Age, sex, phototype, CD4 lymphocytes count, viral load, nadir CD4, antiretroviral exposure, alcohol, tobacco ...
METHODOLOGY Monocentric retrospective study STATISTICS Frailty model, chi2 test, test U INCLUSION CRITERIA Seropositive for HIV, age>18 years Follow-up at least once in the Internal Medicine department between 1995 and 2018 CRITERIA OF EXCLUSION Refusal of the patient or unreachable patient NUMBER OF PATIENTS Between 200 and 300 CALENDAR Duration of inclusions: 3 months Duration of participation of the patient: 20 years (retrospectives ...) Duration of the study: 1 year
详细描述
Rational:
HIV pathology has been associated with an accelerated aging of the infected organism, without anyone knowing how to do it:
- the direct toxicity of the virus;
- CD4 immuno-depletion and its corollary of opportunistic infections, modification of microbiota, ... ;
- Reactive immune stimulation with chronic inflammation;
- the toxicity of antiretrovirals, particularly nucleoside analogues, responsible for acquired mitochondrial cytopathy;
- And, finally, specific environmental factors related to either the mode of acquisition of the infection (transfusion, drug addiction ...), or the frailty induced by the pathology (psychic or social).
The discordant data of the great cohorts must be supported by cohorts of smaller sizes, more exhaustive, both in item and data, more homogeneous in their social determinants.
Population and Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •HIV positive persons followed in Internal Medicine departement of Brest University Hospital
排除标准
- •opposition of the study
结局指标
主要结局
liver aging
时间窗: at last one
elastometry (Fibroscan\*)
renal aging
时间窗: yearly
creatinin level, creatinin clearance, microalbuminuria
Bone aging
时间窗: at last one
osteodensitometry
neurological aging
时间窗: at last one
memory tests
vascular aging
时间窗: at last one
intima-media thickness, systolic and diastolic blood pressure
pulmonary aging
时间窗: at last one
respiratory functional test
heart aging
时间窗: at last one
ECG, echography
次要结局
未报告次要终点