Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 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)
排除标准
- •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
- •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
研究组 & 干预措施
Raltegravir
干预措施: Raltegravir (Drug)
结局指标
主要结局
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
时间窗: from Baseline to Weeks 48 and 96
Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96
次要结局
- Percentage of Participants With HIV Viral Load <50 Copies/mL(from Baseline to Week 96)
研究者
Andrew Carr
Professor, Head Clinical Research program
St Vincent's Hospital, Sydney