Renal, Metabolic, Hepatic and Bone Outcomes in People Living With HIV and Other Co-morbidities Receiving Different Anti-retroviral Regimens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Low bone mineral density
研究概览
简要总结
Multi-arm, non-randomized, quality of life
详细描述
This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 antibody positive
- •Age above 18 years
- •Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
- •Receiving ART regimen, which consists of B/F/TAF, or 1-2 NRTI(s), plus another anti-retroviral drug, including INSTI other than bictegravir, NNRTI, or protease inhibitor
排除标准
- •Recent diagnosis of AIDS within 6 months
- •Recent hospitalization for management of acute medical problems within 6 months
- •Receiving ART regimens other than the combinations listed in Inclusion Criteria
结局指标
主要结局
Low bone mineral density
时间窗: Baseline
Low bone mineral density is defined as T score \<-1.0 in men 50 years and in post-menopausal women at either lumbar spine or femoral neck, and Z score \<-2.0 in men younger than 50 years and pre-menopausal women, as measured by dual energy X-ray absorptiometry (DXA). DXA scan will be performed to measure bone mineral density at lumbar spine and femoral neck.
Renal diseases
时间窗: Baseline
Renal disease is defined as glomerular filtration rate (GFR) \<60 mL/min/1.73m2, or presence of albuminuria, defined as urine albumin:creatinine \>3 mg/mmol, according to Kidney Disease Improving Global Outcomes (KDIGO) categorization of chronic kidney disease. Blood will be taken for creatinine and urine for creatinine and albumin levels.
Liver steatosis and fibrosis
时间窗: Baseline
Liver steatosis is defined as Controlled Attenuated Parameter (CAP) \>248 dB/m and significant fibrosis is defined as liver stiffness \>9.0 kPa, as measured by transient elastography. Transient elastography will be performed to measure CAP and liver stiffness.
Cardiovascular risk
时间窗: Baseline
High cardiovascular disease risk is defined as QRISK3 \>10%. QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org.
Dyslipidemia
时间窗: Baseline
Dyslipidemia is defined as total cholesterol \>5.17 mmol/l, triglyceride \>1.7 mmol/l, HDL cholesterol \<1.03 mmol/l in men and \<1.29 mmol/l in women, or LDL cholesterol \>4.1 mmol/l, or a history of taking anti-hyperlipidemic drugs, according to the National Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines. Fasting blood sample will be taken to measure total, LDL and HDL cholesterol and triglyceride levels.
Health-related quality of life
时间窗: Baseline
any severity of problem in the five dimensions of EQ-5D-5L, EQ-5D-5L index and EQ-VAS EuroQol 5 level EQ-5D version will be performed to measure the above parameters.
次要结局
- Incidences of Comorbidities(12 months or at the time of change of ART regimen)
研究者
Grace Lui
Honorary Clinical Associate Professor
Chinese University of Hong Kong