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临床试验/NCT01591252
NCT01591252已完成不适用

Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Bone Mineral Density

研究概览

简要总结

In a group of HIV-positive patients under observation since their first exposure to ART or monitored off of ART, BMD changes over one year will be determined. For each subject, the investigators will also determine associations between changes in BMD and 1) ART initiation, 2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}).

Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of ART, after excluding those subjects treated with tenofovir.

BMD will decrease most significantly in HIV-positive subjects with the highest levels of cumulative viremia.

HIV-positive persons with highest cumulative viremia will have the highest levels of inflammation, as measured by pro-inflammatory cytokines.

Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare sample and fracture association with the use of varying ART medications among dual-eligible persons in Medicare and Medicaid datasets.

Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest duration of ART exposure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • treatment naïve patients seen in the 1917 Clinic between January 1, 2000 and May 1, 2010
  • currently under care at the time of the initiation of the study (>1 clinic visit in the past 12 months)

排除标准

  • history of chronic renal failure (estimated GFR <30ml/min)
  • known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary hyperparathyroidism, Paget Disease, Osteogenesis Imperfecta)
  • multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease, or persons currently treated with or plans to begin an osteoporosis-specific medication (including estrogen)
  • treatment with oral glucocorticoids and anticonvulsants

结局指标

主要结局

Bone Mineral Density

时间窗: 1 year

Change in BMD after 1 year

次要结局

  • Fracture in HIV(10years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy H. Warriner

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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