Safety Study of Maraviroc's Effect on Human Osteoclasts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluation of maraviroc's effect to bone metabolism and bone mineral density
研究概览
简要总结
This study is to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.
详细描述
An observational study to investigate the safety of maraviroc by examining whether there is bone metabolism dysfunction in actual use of maraviroc in human body, or not, measuring bone mineral density and markers for bone formation, desorption and chemokine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:
- •Those whose primary care physician acknowledged the necessity of maraviroc treatment due to multi-resistance HIV strain that is confirmed to have CCR5 tropism.
- •Those who are willing and able to consent to this study
- •20 years old or older
排除标准
- •Cases applicable to ANY condition of the following:
- •Those who are not suited for maraviroc (whose HIV strain to be CXCR4 tropism)
- •Others who the principle investigator physician considered to be excluded
研究组 & 干预措施
Maraviroc
Those whose take maraviroc as a part of their HIV treatment
干预措施: Maraviroc (Drug)
结局指标
主要结局
Evaluation of maraviroc's effect to bone metabolism and bone mineral density
时间窗: 78 weeks
Follow up HIV infected patients who take maraviroc for their bone mineral density by DEXA and for following blood/urine markers of bone metabolism and chemokine for 72 weeks: * Bone and chemokine markers (DPD, NTX, CTX, TRACP, BAP, osteocalcin, MIP-1alpha, MIP-1beta and RANTES) * Dual-energy X-ray absorptiometry
次要结局
- Duration of the treatment efficacy(72 weeks)