Bone Health in Older Ugandan Women with and without HIV

项目摘要/摘要 约翰霍普金斯大学-乌干达临床试验单位(JHU-CTU)一直在 作为DAIDS资助的艾滋病毒网络研究的一部分，临床试验研究的前沿，目标是 开展有效、安全的艾滋病预防和治疗干预措施 有限的设置。在这个周期(2020-2027年)，联合胡塞--反恐联盟及其两个乌干达研究站点， 旨在评估新的抗逆转录病毒治疗和预防方案，新的递送系统 和/或用于预防高危妇女和青少年的新型免疫疗法；以及 用于治疗感染艾滋病毒的孕妇、青少年和儿童。CTU的目标也是 解决预防和治疗包括结核病和乙肝在内的艾滋病毒混合感染的问题； 针对新发感染的疫苗。作为进一步的目标，JHU-CTU继续致力于 指导和培养国际研究人员，使其成为开展艾滋病毒研究的领导者。 这一行政副刊属于JHU乌干达CTU旨在解决安全问题的范围， 在资源有限的情况下，用于艾滋病毒预防和治疗的抗逆转录病毒药物(短期和长期) 设置，如乌干达。因为抗逆转录病毒药物在不同的种族/民族中可能有不同的安全特征 对于不同的人群，使用适当的正常值来评估ARV的安全性是很重要的 以及性别、年龄和种族/族裔在安全概况方面是否存在差异。 例如，基于替诺福韦的抗逆转录病毒治疗(TDF-AFT)已知与骨质减少有关 治疗第一年的骨密度(BMD)。然而，人们对其后续影响知之甚少。 包括绝经后妇女在内的国际人群的终生TDF-ART 与HIV阴性的老年人相比，他们患骨质疏松症和骨折的风险是否增加 女人。艾滋病毒阴性的老年非洲妇女的骨密度“正常值”是不可用的。 因此，对于这一行政补充，JHU CTU MU-JHU临床研究网站(CRS) 旨在评估和比较老年女性艾滋病病毒携带者的骨密度和身体成分 终身抗逆转录病毒治疗对年龄相近的艾滋病毒阴性乌干达妇女的BMD结果。Mu-ju会 从AFRICOS招募236名年龄在40-60岁以上的女性(HIV感染者和HIV阴性者) 在乌干达的Kayunga进行DXA成像扫描和骨健康实验室研究。数据 从这一横断面分析将被用来：(1)比较生活在乌干达的妇女的骨密度 对于艾滋病毒和未感染艾滋病毒的妇女，(2)检查身体成分(即内脏肥胖症和 BMI)，(3)分析骨密度分布，并与标准骨密度进行比较 以人口为基础的队列。这项研究将收集有关骨密度和安全性的有价值的规范数据 关于非洲裔老年妇女骨折风险的数据，包括那些生活在美国的老年妇女。

Project Summary/Abstract The Johns Hopkins University-Uganda Clinical Trial Unit (JHU-CTU) has been at the forefront of clinical trial research as part of the DAIDS funded HIV network studies with a goal of developing effective and safe interventions for both HIV prevention and treatment in resource limited settings. For this cycle (2020-2027), the JHU-CTU with its two Ugandan research sites, aims to evaluate new antiretroviral treatment and prevention regimens, novel delivery systems and/or novel immune-based therapy for prevention among at risk women and adolescents; and for treatment of HIV-infected pregnant women, adolescents and children. The CTU aims also address prevention and treatment of HIV coinfections including TB and HBV; and studies of vaccines for emerging infections. As a further aim, the JHU-CTU continues its commitment to mentor and develop international investigators to become leaders in conducting HIV research. This administrative supplement falls within the JHU Uganda CTU aim addressing the safety, (short and long term) of ARVs used for both HIV prevention and treatment in resource-limited settings such as Uganda. As ARVs may have different safety profiles in differing racial/ethnic groups, it is important to use appropriate normal values to assess ARV safety across diverse populations; and if there are differences in safety profile by sex, age and race/ethnicity. Tenofovir-based ART (TDF-AFT) for example is known to be associated with decreased bone mineral density (BMD) during the first year of treatment. However, little is known on later effects of lifetime TDF-ART in international populations including among post-menopausal women and if they are at increased risk for osteoporosis and bone fracture compared to older HIV negative women. And BMD “normal values” for older HIV negative African women are not available. Thus, for this administrative supplement, the JHU CTU MU-JHU clinical research site (CRS) aims to assess and compare (BMD) and body composition among older women with HIV on lifetime ART, to BMD results among HIV negative Ugandan women of similar age. MU-JHU will recruit 236 women (both HIV infected and HIV negative) age 40-60+ years from the AFRICOS cohort in Kayunga, Uganda to perform DXA imaging scans and bone health lab studies. Data from this cross-sectional analysis will be used to: (1) compare BMD in Ugandan women living with HIV and HIV-uninfected women, (2) examine body composition (i.e., visceral adiposity and BMI) in these two groups, and (3) analyze the distribution of BMD for comparison to standard population-based cohorts. This study will collect valuable normative data on BMD and safety data on fracture risk among older women of African origin, including those living in the U.S.