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

A5163：骨矿物质密度降低的艾滋病毒感染者每周使用阿仑膦酸钠

• 批准号: 7378004
• 负责人: ROBERT C KALAYJIAN
• 金额: $ 0.39万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378004
• 关键词: A5163; WEEKLY; ALENDRONATE; HIV; SUBJECTS

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.

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。 A5163是双膦酸酯丙膦酸盐的II期，随机，双盲，安慰剂对照研究，用于治疗HIV相关的降低骨矿物质密度（BMD）。除了补充钙/维生素D补充剂外，受试者还将接受48周的盲研究治疗。这项研究将检查每周接受稳定抗逆转录病毒疗法（ART）的HIV感染受试者的腰椎和HIP BMD的影响，此外还有每日钙/维生素D补充剂。该研究还将评估该人群中alendronate的安全性和耐受性。 由于没有有关HIV感染妇女使用阿仑膦酸盐使用的数据，并且由于BMD的减少在绝经前妇女中尤其严重，因此已修改了A5163的主要目标，以评估Alendronate对HIV感染的艾滋病妇女对BMD的疗效。 将研究八十名受试者（每只手臂40名女性，27名女性和13名男性）。受HIV感染的男性和女性大于或等于25岁，BMD降低，如腰椎DEXA T评分小于-1.5的记录。受试者必须具有小于或等于5000份/ml的等离子HIV-1 RNA水平，CD4+计数大于或等于100个单元/mm3，并且在研究进入前至少12周接受稳定的ART，并且没有显着改变ART，锻炼ART，或饮食饮食的计划，或者在研究期间没有计划。 BMD的变化将通过串行DEXA评估。此外，将收集血液以未来的骨转换测量，该测量将通过骨吸收（血清C连接的端肽[CTX]）和骨形成（血清骨碱性磷酸酶和骨钙化蛋白）评估。评估将在筛查，进入和第2、12、24、36和48周进行。病毒载荷和CD4+仅在筛选时确定。