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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。A5163是一项II期、随机、双盲、安慰剂对照研究，研究双膦酸盐阿仑膦酸盐治疗HIV相关的骨密度（BMD）降低。除钙/维生素D补充剂外，受试者将接受为期48周的设盲研究治疗。本研究将检查每周一次阿仑膦酸钠对接受稳定抗逆转录病毒治疗（ART）的HIV感染受试者腰椎和髋部BMD的影响，以及每日补充钙/维生素D。该研究还将评估阿仑膦酸钠在该人群中的安全性和耐受性。 由于没有关于阿仑膦酸钠在HIV感染女性中使用的数据，并且由于BMD降低在绝经前女性中具有特别严重的后果，因此A5163的主要目的已被修改为评价阿仑膦酸钠对HIV感染女性BMD的疗效。 将研究80例受试者（每组40例，每组27例女性和13例男性）。将入组年龄≥ 25岁、腰椎DEXA t评分小于-1.5证实BMD降低的HIV感染男性和女性。受试者的血浆HIV-1 RNA水平必须小于或等于5000拷贝/ml，CD 4+计数大于或等于100个细胞/mm 3，并且在研究入组前接受稳定的ART至少12周，在研究入组时没有计划在研究期间显著改变ART、运动习惯或饮食。 将通过连续DEXA评估BMD的变化。此外，将采集血液用于未来可能的骨转换测量，将通过骨吸收标志物（血清C-连接端肽[CTx]）和骨形成标志物（血清骨碱性磷酸酶和骨钙素）进行评估。将在筛选、入组以及第2、12、24、36和48周时进行评价。仅在筛选时测定病毒载量和CD 4+。

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.