NCT01634607已完成不适用
Bone Health and Vitamin D Status in Thai HIV-1 Infected and Uninfected Adults (A Substudy of TNT-HIV 003: Trends of Morbidity and Mortality Among Thai HIV-infected and HIV-uninfected Patients: a Five-year Prospective Cohort Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- vitamin D deficiency
研究概览
简要总结
This study will compare and assess the prevalence of osteopenia and vitamin D deficiency as well as effects of TDF on the patients' bone among HIV positive and negative patients.
详细描述
To determine the prevalence of osteopenia and vitamin D deficiency in HIV-1 infected, HAART naive Thai patients compared to HIV-1 uninfected Thai participants. Furthermore, to determine the change in BMD after twelve months in HIV-1 infected Thai patients on a TDF-based HAART regimen compared to patients on a non-TDF containing regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV uninfected:
- •HIV negative confirmed by HIV testing
- •Age 30 years and older
- •Thai nationality
- •Signed informed consent form for the study
- •HIV-infected, HAART naïve:
- •Recorded HIV infection
- •Age 30 years and older
- •Thai nationality
- •Signed informed consent form for the study
- •HIV-infected, HAART group:
- •Recorded HIV infection
- •Age 30 years and older
- •Thai nationality
- •HAART naïve at baseline, planned to start HAART within 90 days. Past exposure to antiretroviral therapy during pregnancy for the prevention of mother to child transmission of HIV ≥ 3 months prior to screening will be allowed
- •Signed informed consent form for the study
排除标准
- •HIV uninfected
- •Currently pregnant or lactating
- •Recent hospitalization
- •Use of anticonvulsants, steroids or vitamin D supplements
- •HIV-infected, HAART naïve
- •CD4 < 350
- •Currently pregnant/lactating
- •Recent hospitalization
- •Signs of wasting
- •Use of anticonvulsants, steroids or vitamin D supplements
- •HIV-infected, HAART group:
- •Prior antiretroviral therapy use
- •Currently pregnant/lactating
- •Recent hospitalization
- •Signs of wasting
- •Active opportunistic infection
- •Use of anticonvulsants, steroids or vitamin D supplements
结局指标
主要结局
vitamin D deficiency
时间窗: 60 months
development of vitamin D deficiency
osteopenia
时间窗: 60 months
development of osteopenia
BMD
时间窗: 1 year
changes of BMD
次要结局
未报告次要终点
研究者
研究点 (1)
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