Switch From Tenofovir to Raltegravir for Low Bone Mineral Density (TROP)
The purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with HIV infection who switch their HIV medication tenofovir to another HIV medication raltegravir.
Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic patients switching from ART including tenofovir disoproxil fumarate (TDF) and a ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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New South Wales
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Sydney、New South Wales、澳大利亚、2010
- St Vincents Hospital
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Sydney、New South Wales、澳大利亚、2010
- East Sydney Doctors
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Sydney、New South Wales、澳大利亚、2010
- Holdsworth Medical Practice
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Victoria
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Melbourne、Victoria、澳大利亚、3004
- The Alfred Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- provision of written, informed consent
- HIV-infected adults at least 18 years of age
- receiving stable ART including TDF and a r/PI for the previous 6 months
- no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
- plasma HIV RNA < 50 copies/ml for at least the previous 3 months
spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)
Exclusion Criteria:
- participation in any other clinical trial (unless approved by the study PI)
- use of TDF for previously active chronic hepatitis B infection
- receiving or requiring therapy for low BMD (including prior fragility fracture)
- using oral corticosteroids or inhaled fluticasone
- virological failure on, or intolerance to, RAL
- contra-indication to RAL therapy (see appendix 2)
- breast-feeding
- pregnancy
- secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency, hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone > 25% below lower limit of reference range and/or luteinizing hormone > 2 x upper limit of normal (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference ranges
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:拉替拉韦
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Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
大体时间:from Baseline to Weeks 48 and 96
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Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96
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from Baseline to Weeks 48 and 96
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Percentage of Participants With HIV Viral Load <50 Copies/mL
大体时间:from Baseline to Week 96
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Plasma HIV viral load remained <50 copies/mL
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from Baseline to Week 96
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合作者和调查者
调查人员
- 首席研究员:Andrew D Carr, Professor、St Vincents Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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