NCT01274780已完成4 期
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
Juan A. Arnaiz1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes in total cholesterol
研究概览
简要总结
This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels.
Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥ 4.5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients of both sexes aged 18 years or more. Women of childbearing potential must commit to sexual abstinence or use barrier contraceptive methods during the study.
- •Diagnosis of infection by HIV-1 (according to standard diagnostic criteria)
- •Not previously treated with antiretroviral drugs
- •Plasma viral load > = 1000 copies / ml
- •Clinically stable patients in the investigator's opinion at the time of inclusion
- •Able to meet the schedule of study visits and other protocol requirements
- •Written informed consent to participate in the study and undergo tests and examinations that entails
排除标准
- •ALT, AST levels greater than or equal to 5 times ULN (upper limit of normal)
- •serum creatinine level greater than 2 times ULN
- •Diabetes Mellitus (according to clinical and / or use of anti-diabetic agents)
- •Obesity (BMI ≥ 30 kg/m2)
- •Use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study.
- •Active opportunistic infection requiring intravenous treatment
- •Patients with known hypersensitivity to any of the products under study
- •Use of drugs formally contraindicated in the product information for any of the drugs under study
- •Contraindication to the use of any of the drugs under study
- •Women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test
研究组 & 干预措施
Darunavir / Ritonavir
Experimental
干预措施: Darunavir / Ritonavir + Tenofovir / Emtricitabine (Drug)
Atazanavir / Ritonavir
Experimental
干预措施: Atazanavir / Ritonavir + Tenofovir / Emtricitabine (Drug)
结局指标
主要结局
Changes in total cholesterol
时间窗: 24 weeks
次要结局
- Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol(24, 48 and 96 weeks)
- Cardiovascular risk according to the Framingham scale.(24, 48 and 96 weeks.)
- Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index))(24, 48 and 96 weeks)
- inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin)(24, 48 and 96 weeks)
- RNA viral load <50 copies / mL(24, 48 and 96 weeks.)
- CD4+ cells count(24, 48 and 96 weeks)
- clinical adverse events, including events related to depositional patterns, laboratory abnormalities and incidence of treatment discontinuation because of toxicity or intolerance in each of the treatment arms.(24, 48 and 96 weeks)
- distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan(48 and 96 weeks)
研究者
Juan A. Arnaiz
Clinical research Manager
Hospital Clinic of Barcelona
研究点 (1)
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