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。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这是由美国国立卫生研究院，美国国家招募和传染病研究所，艾滋病部门赞助的成人艾滋病临床试验小组的多中心试验。这项研究将研究增加艾滋病毒感染者骨矿物质密度的方法。骨髓密度降低（BMD）已在多达50％的艾滋病毒受试者中描述，严重的骨质疏松症的严重占21％，但这些骨异常的机制尚不清楚。帮助增加BMD的一种方法是用钙和维生素D补充饮食D。另一种方法是服用Alendronate，这是FDA批准的药物（尽管不是该受试者人群），以逆转BMD的降低。这项研究将测试Alendronate是否能够逆转HIV感染受试者的BMD降低，以及与抗逆转录病毒疗法一起服用时，抗苯膦酸盐治疗的耐受性，以及钙和维生素D补充是这组受试者的更好治疗选择。 受试者将被随机分为两组：一组将每周与钙和维生素D补充剂一起接受Alendronate，另一组将每周接受安慰剂，以及钙和维生素D补充剂。在研究过程中，受试者将进行四次DEXA扫描，以评估Alendronate是否正在增加其BMD。 我们将要求GCRC员工在本研究中管理四个DEXA扫描。筛选，第2、12、24、36和48周的访问将在Actu Pi和Co-Pi和研究护士的AUSPICES的G255 Mayo的AIDS临床试验单元（ACTU）中进行。 ACTU研究护士将负责本研究的所有APSECT（请参阅标题为“ 6.0临床和实验室评估”的协议的第36页。