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 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。这是成人艾滋病临床试验小组的一项多中心试验，由美国国立卫生研究院、国家过敏和传染病研究所艾滋病司赞助。这项研究将探讨增加艾滋病毒感染者骨矿物质密度的方法。高达 50% 的 HIV 受试者出现骨髓密度 (BMD) 下降，高达 21% 的受试者患有严重骨质疏松症，但这些骨异常的机制仍不清楚。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），可以逆转 BMD 的下降。这项研究将测试阿仑膦酸钠是否能够逆转 HIV 感染者 BMD 的下降，以及阿仑膦酸钠与抗逆转录病毒疗法联合使用时的耐受性如何，以及补充钙和维生素 D 是否是该群体的更好治疗选择的科目。 受试者将被随机分为两组：一组每周接受阿仑膦酸钠以及钙和维生素 D 补充剂，另一组每周接受安慰剂以及钙和维生素 D 补充剂。受试者在研究过程中将接受四次 DEXA 扫描，以评估阿仑膦酸钠是否增加了他们的 BMD。 我们将要求 GCRC 工作人员在本研究中进行四次 DEXA 扫描。筛查、入组、第 2、12、24、36 和 48 周的就诊将在位于 G255 Mayo 的艾滋病临床试验单位 (ACTU) 进行，由 ACTU PI 和联合 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（参见题为“6.0 临床和实验室评估”的方案第 36 页。