Frequency and Clinical Significance of Renal and Bone Toxicity in HIV-infected Patients: Role of Classical Factors, HIV Infection, and Antiretroviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Incidence of Renal and Bone toxicity
研究概览
简要总结
The purpose of this study is to determine the frequency of renal and bone toxicity in HIV infected patients receiving antiretroviral therapy, and the outcome in terms of treatment change or/and virological failure, in relation with the presence of classical factors, such as diabetes or hypertension, the role of HIV itself, because of chronic inflammation, and the effects of antiretroviral medication.
详细描述
This is a retrospective cohort study involving 300 patients to determine the frequency of renal and bone comorbidities/toxicity in a large population of HIV-infected patients receiving antiretroviral therapy, in order to establish the differential role of classical factors, HIV infection, or antiretroviral therapy.
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
- •Confirmed HIV infection
排除标准
- •Pregnancy
- •Prior therapy with antineoplastic chemotherapy or chronic treatment with corticosteroids
- •Previous chronic therapy with antiresorptive bone therapy
结局指标
主要结局
Incidence of Renal and Bone toxicity
时间窗: Patients will be evaluated for 2 years before
Number and percentage of patients with: * Confirmed estimated glomerular filtration rate (eGFR) by CKD (chronic kidney disease)-epi equation decrease to \< 60 ml/min, or/and * More than 25% of eGFR decrease during therapy, or/and * Tubular toxicity defined as at least two of confirmed proteinuria (\> 300 mg/g), glycosuria with euglycemia, fractional excretion of urinary phosphate \> 20%, or of uric acid \> 10%. AND * Number and percentage of patients with bone mineral density (BMD) decrease \> 10% during follow up or progression to osteopenia (from normal) or to osteoporosis (from osteopenia)
次要结局
- Consequences of renal or bone toxicity(Patients will be evaluated for 2 years before)