Metabolic Profile and Cardiovascular Biomarker Pattern Compared in naíve Patients Initiating HAART With TDF-FTC and Raltegravir 400mg BID Vs Darunavir 800 mg Plus Ritonavir 100 mg QD; a One Year Follow-up Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Insulin resistance defined by HOMA index.
研究概览
简要总结
The advent of new antiretroviral drugs improved the management of HIV naive patients in terms of efficacy. However, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial.
Moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and QOL of HIV patients.
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
- 未提供
排除标准
- •pregnancy
- •previous Antiretroviral exposure
结局指标
主要结局
Insulin resistance defined by HOMA index.
时间窗: baseline and week 12, 24, 36 and 48
lipid profile defined as a clinically significant increment (delta) in Total cholesterol LDL, HDL y non-LDL cholesterol.
时间窗: baseline and week 12, 24, 36 and 48
Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs...
时间窗: baseline and week 12, 24, 36 and 48
次要结局
- Efficacy defined as viral suppression and CD4 count recovery(baseline and week 12,24,36,48)
- Antiretroviral adherence and quality of life items.(baseline and week 12,24,36,48)