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

ACTG A5163：一项 II 期、随机、双盲、安慰剂对照研究

• 批准号: 7375918
• 负责人: JENNIFER BALFOUR
• 金额: $ 0.99万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375918
• 关键词: ACTG; A5163; PHASE; II; RANDOMIZED

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".

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。这是一项成人艾滋病临床试验组的多中心试验，由美国国立卫生研究院、美国国立传染病与寓言研究所艾滋病分部赞助。这项研究将寻找增加HIV感染者骨密度的方法。在高达50%的HIV受试者中描述了骨髓密度（BMD）降低，其中高达21%的受试者患有严重的骨质疏松症，但这些骨异常的潜在机制仍不清楚。增加骨密度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仑膦酸钠，这是一种FDA批准的药物（尽管不适用于该受试者人群），以逆转BMD下降。本研究将测试阿仑膦酸钠是否能够逆转HIV感染受试者的BMD下降，以及阿仑膦酸钠治疗与抗逆转录病毒治疗联合使用时的耐受性如何，以及钙和维生素D补充剂是否是这组受试者的更好治疗选择。 受试者将被随机分为两组：一组将沿着每周接受阿仑膦酸钠与钙和维生素D补充剂，另一组将沿着每周接受安慰剂与钙和维生素D补充剂。在研究过程中，受试者将进行四次DEXA扫描，以评估阿仑膦酸钠是否增加其BMD。 我们将要求GCRC工作人员在本研究中进行四次DEXA扫描。筛选、入组、第2周、第12周、第24周、第36周和第48周访视将在G255马约的艾滋病临床试验部门（ACTU）进行，由ACTU PI和共同PI以及研究护士主持。ACTU研究护士将负责本研究的所有方面（见标题为“6.0临床和实验室评价”的方案第36页）。