A5163: WEEKLY ALENDRONATE IN HIV SUBJECTS WITH DECREASED BONE MINERAL DENSITY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。A5163是一项II期随机、双盲、安慰剂对照研究，用于治疗HIV相关性骨密度下降。受试者将接受为期48周的盲法研究治疗，此外还补充钙/维生素D。这项研究将考察每周服用阿伦磷酸钠对接受稳定的抗逆转录病毒治疗(ART)的HIV感染者腰椎和髋部骨密度的影响，同时每天补充钙/维生素D。该研究还将评估阿仑磷酸钠在该人群中的安全性和耐受性。由于没有关于感染艾滋病毒的妇女使用阿伦磷酸钠的数据，而且由于减少的骨密度对绝经前的妇女具有特别严重的后果，因此对A5163的主要目标进行了修改，以评估阿伦磷酸钠对感染艾滋病毒的妇女的骨密度的疗效。80名受试者(每臂40人，女性27人，男性13人)将被研究。感染HIV的男性和女性年龄大于或等于25岁，腰椎DXA t评分低于-1.5分，骨密度降低，将被纳入。受试者必须血浆HIV-1RNA水平低于或等于5000拷贝/毫升，CD4计数大于或等于100个/mm3，并在进入研究前至少12周接受稳定的抗逆转录病毒治疗，在研究进入时没有计划在研究期间显著改变抗逆转录病毒治疗、运动习惯或饮食。骨密度的变化将通过系列的DEXA进行评估。此外，还将采集血液，用于未来可能的骨转换测量，这将通过骨吸收(血清C-连接端肽[CTX])和骨形成(血清骨碱性磷酸酶和骨钙素)的标记物进行评估。评估将在筛选、入职以及第2、12、24、36和48周进行。病毒载量和CD4只有在筛查时才能确定。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5163 is a phase II, randomized, double-blind, placebo-controlled study of the bisphosphonate alendronate for the treatment of HIV-associated decreased bone mineral density (BMD). Subjects will receive blinded study treatment for 48 weeks, in addition to a calcium/vitamin D supplement. This study will examine the effect of weekly alendronate on lumbar spine and hip BMD in HIV-infected subjects receiving stable antiretroviral therapy (ART), in addition to daily calcium/vitamin D supplement. The study also will assess the safety and tolerability of alendronate in this population. Because no data are available on alendronate use in HIV-infected women, and because decreased BMD has especially serious consequences in pre-menopausal women, the primary objective of A5163 has been modified to evaluate the efficacy of alendronate on BMD in HIV-infected women. Eighty subjects (40 per arm, 27 female and 13 male in each) will be studied. HIV-infected men and women greater than or equal to 25 years of age, with decreased BMD as documented by a lumbar spine DEXA t-score of less than -1.5 will be enrolled. Subjects must have a plasma HIV-1 RNA level of less than or equal to 5000 copies/ml, a CD4+ count of greater than or equal to 100 cells/mm3, and be receiving stable ART for a minimum of 12 weeks prior to study entry, with no plan at study entry to significantly alter ART, exercise habits, or diet for the duration of the study. Changes in BMD will be assessed by serial DEXA. In addition, blood will be collected for possible future measurements of bone turnover, which will be assessed by markers of bone resorption (serum C-linked telopeptides [CTx]) and of bone formation (serum bone alkaline phosphatase and osteocalcin). Evaluation will be performed at screening, entry, and weeks 2, 12, 24, 36, and 48. Viral load and CD4+ will only be determined at screening.