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临床试验/NCT02827643
NCT02827643Unknown不适用

Vitamin D and Calcium Supplement Attenuate Bone Loss Among HIV- Infected Patients Receiving Tenofovir Disoproxil Fumarate, Lamivudine or Emtricitabine and Efavirenz: An Open-label, Randomized Controlled Trial

Mahidol University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
48
试验地点
1
主要终点
percentage change of bone density

研究概览

简要总结

The purpose of this study is to determine whether calcium and vitamin D supplement can attenuate bone loss in HIV-infected-patients in Thailand who receive Tenofovir disoproxil fumarate.

详细描述

Early initiation of antiretroviral therapy (ART) has transformed HIV infection into chronic manageable disease. Although incidence of AIDS-related mortality has decreased, it has increased for other co-morbid conditions including decrease bone mass, osteoporosis, fragility fracture. There are multi-factorial that contribute to bone loss in HIV-infected individuals including HIV virus itself that shift bone remodeling pathway toward bone resorption, lifestyle and behavioral factors, co-morbid conditions and ART.

Initiation of ART is associated with 2%-6% reduction in bone mineral density during the first 2 years of treatment regardless of ART regimens and then stabilization thereafter in the majority of the study. This magnitude of bone loss is similar to postmenopausal women during the first year.

Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue reverse transcriptase inhibitor, has been associated with greater bone loss than other reverse transcriptase inhibitors, that is recommended as the first line treatment in Thailand. Nonetheless there is an evidence in western country that calcium and vitamin D supplement can attenuate bone loss in naive HIV-infected individual who start ART with TDF. Even though many experts recommend to avoid TDF and prefer abacavir, NRTIs which affect bone loss less than other NRTIs, in high fracture risk patients, more than less HIV-infected-patients can access to abacavir in resource limiting country. This research aims to study bone mineral density (BMD) in HIV infected-patient in Thai population who receive tenofovir with calcium and vitamin D supplement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-1-infected patients who start 3TC or FTC,TDF and EFV within 3 months before enrollment
  • Age 18-50 years

排除标准

  • CrCl <60mL/min/1.73 m2 ¶-
  • CaCO3 supplement >500 mg/day or vitamin D supplement >800 IU/day
  • Steroid used (equivalent to prednisolone> 5 mg/day more than 3 months )
  • Osteoporosis treatment
  • Serum Ca >10.5 g/dL
  • History fragility fracture
  • Pregnancy or breastfeeding
  • Secondary amenorrhea
  • Hyperthyroidism
  • History of kidney stone
  • Current active opportunistic infection

研究组 & 干预措施

TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement

Active Comparator

Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study

干预措施: TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement (Drug)

TDF/3TC or FTC/EFV

Other

the subjects in this arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.

干预措施: TDF/3TC or FTC/EFV (Other)

结局指标

主要结局

percentage change of bone density

时间窗: 24 weeks

次要结局

  • change in 25(OH)D level(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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