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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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钠治疗hiv相关的骨密度降低（BMD）。受试者将接受为期48周的盲法研究治疗，并补充钙/维生素D。本研究将检查每周服用阿仑膦酸钠对接受稳定抗逆转录病毒治疗（ART）的hiv感染者腰椎和髋部骨密度的影响，此外每日补充钙/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。由于没有关于艾滋病毒感染妇女使用阿仑膦酸钠的数据，并且由于骨密度降低对绝经前妇女有特别严重的后果，因此A5163的主要目的已被修改为评估阿仑膦酸钠对艾滋病毒感染妇女骨密度的疗效。80名受试者（每组40人，每组27名女性和13名男性）将被研究。hiv感染的男性和女性大于或等于25岁，骨密度降低，腰椎DEXA t评分低于-1.5。受试者的血浆HIV-1 RNA水平必须小于或等于5000拷贝/ml， CD4+计数大于或等于100细胞/mm3，并且在研究开始前至少12周接受稳定的抗逆转录病毒治疗，在研究开始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。BMD的变化将通过连续DEXA来评估。此外，将采集血液用于将来可能的骨转换测量，这将通过骨吸收标志物（血清c链末端肽[CTx]）和骨形成标志物（血清骨碱性磷酸酶和骨钙素）来评估。评估将在筛选、入组和第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.