ACTG A5163: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ON

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。这是一项成人艾滋病临床试验小组的多中心试验，由国家卫生研究院、国家婚姻和传染病研究所艾滋病司赞助。这项研究将寻找增加HIV感染者骨密度的方法。据报道，多达50%的HIV受试者骨髓密度(BMD)降低，其中高达21%的人患有严重的骨质疏松症，但这些骨骼异常的机制尚不清楚。帮助增加BMD的一种方法是在饮食中补充钙和维生素D。另一种方法是服用阿伦磷酸钠，这是FDA批准的药物(尽管不适用于这一受试者)，以逆转骨密度下降的趋势。这项研究将测试阿伦磷酸钠是否能够逆转艾滋病毒感染者减少的骨密度，当与抗逆转录病毒疗法结合使用时，阿伦磷酸钠治疗的耐受性如何，以及补充钙和维生素D是否是这一组患者的更好治疗选择。受试者将被随机分为两组：一组每周服用阿伦磷酸钠以及钙和维生素D补充剂，另一组每周服用安慰剂以及钙和维生素D补充剂。受试者将在研究过程中进行四次地塞米松扫描，以评估阿伦磷酸钠是否增加了他们的BMD。在这项研究中，我们将要求GCRC工作人员进行四次DEXA扫描。筛查、参赛、第2周、第12周、第24周、第36周和第48周的访问将在位于G255 Mayo的艾滋病临床试验股(ACTU)进行，由ACTU PI和协理PI和研究护士主持。ACTU研究护士将负责这项研究的所有部分(见题为“6.0临床和实验室评估”的规程第36页)。

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. This is a multicenter trial of the Adult AIDS Clinical Trials group sponsored by the National Institutes of Health, National Institute of Allegery and Infectious Diseases, Division of AIDS. This study wil look at ways to increase bone mineral density in HIV infected people. Decreased bone marrow density (BMD) has been described in up to 50% of HIV subjects, with severe osteoporosis in up to 21%, yet the mechanisms underlying these bone abnormalities remains unclear. One way to help increase BMD is to supplement the diet with calcium and vitamin D. Another way is to take alendronate, which is an FDA approved drug (although not for this subject population) to reverse decreased BMD. This study will test whether or not alendronate will be able to reverse decreased BMD in HIV-infected subjects and how well alendronate therapy is tolerated when taken in conjunction with antiretroviral therapy, and whether calcium and vitamin D supplementation is a better treatment option for this group of subjects. Subjects will be randomized into two groups: one group will receive alendronate every week along with calcium and vitamin D supplements, the other group will receive a placebo every week along with calcium and vitamin D supplements. Subjects will have DEXA scans four times during the course of the study to evaluate whether or not alendronate is increasing their BMD. We will be asking the GCRC staff to administer the four DEXA scans in this study. The screening, entry, week 2, 12, 24, 36 and 48 visits will take place in the AIDS Clinical Trials Unit (ACTU) in G255 Mayo under the auspices of the ACTU PI and co-PI and research nurses. The ACTU research nurses will be responsible for all apsects of this study (see page 36 of the protocol entitled "6.0 Clinical and Laboratory Evaluations".