EUCTR2018-004499-36-ES进行中（未招募）1 期
Study to assess bone health with bone mineral density, bone microarchitecture and bone tissue quality after switching from a TDF regimen to Bictegravir-TAF-FTC - Study of the bone after the change to bictegravir-TAF
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Treated Adult patients for HIV, virologically suppressed during a regimen containing TDF for more than 48 weeks, regardless of the BMD values
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Patients who have been previously exposed to any medication that may affect bone, such as systemic glucocorticoids and anti-osteoporosis medications.
- •- Patients previously diagnosed with conditions that could affect bone: chronic kidney disease (GFR MDRD <45 ml / min / 1.73m ^ 2), chronic untreated endocrine disorders, end-stage decompensated liver disease or malabsorptive disorders; or other bone diseases such as Paget's bone disease; neoplasia or any condition that, in the opinion of the investigator, may interfere with the study protocol
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