Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
研究概览
简要总结
This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats.
Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.
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
- •Provision of signed, informed consent
- •Age >18 years
- •HIV infection documented by HIV antibody test and Western Blot prior to study entry
- •No previous ART OR no ART for 6 months prior to randomisation
- •CD4+ count of <500 cells/mm or viral load >10,000 copies/ml within 60 days prior to randomisation
- •No genotypic resistance to Raltegravir, Tenofovir/emtricitabine, Darunavir, Ritonavir
- •Body mass index less than 30kg/m2
排除标准
- •Primary HIV infection within the last 6 months
- •Active infection or opportunistic illness within the previous 30 days
- •Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
- •Use of lipid-lowering therapy
- •Diabetes mellitus (fasting glucose >7.0mml/l or a prior diagnosis of diabetes)
- •Use of oral prednisolone > 7.5mg daily or equivalent
- •pregnancy or Breast feeding
- •proven hypersensitivity to one or more components of the study meal
研究组 & 干预措施
1.Raltegravir plus truvada
Raltegravir 400mg twice daily plus truvada 300mg/200mg once daily for 24 weeks
干预措施: Darunavir, ritonavir, tenofovir/emtricitabine (Truvada) (Drug)
2. ritonavir boosted darunavir plus truvada
Darunavir 800mg with ritonavir 100mg plus truvada 300mg/200mg once daily for 24 weeks
干预措施: raltegravir plus truvada (Drug)
结局指标
主要结局
To compare the effects of ritonavir plus darunavir daily to raltegravir twice daily on post prandial lipid responses over 24 weeks
时间窗: 24 weeks
Fasting samples will be taken for total cholesterol, LDL and HDL cholesterol, and triglycerides. Repeat lipid samples will be collected before a high fat meal is consumed. After the meal is completed , blood will be collected at 1, 2, 3, and 4 hours at baseline, week 4 and week 24 visits.
次要结局
- Other metabolic parameters(24 weeks)
- Arterial stiffness(24 weeks)
- safety(24 weeks)
研究者
Andrew Carr
Head, Clinical Research Program
St Vincent's Hospital, Sydney