SECONDARY DATA ANALYSES AND INVESTIGATION OF RESEARCH CONCEPT PROPOSALS FROM THE PROSPECTIVE COHORT OF HIV AND ZIKA IN INFANTS AND PREGNANCY STUDY (HIV-ZIP)

二手数据分析和调查婴儿和妊娠研究中艾滋病毒和寨卡病毒前瞻性队列的研究概念提案 (HIV-ZIP)

• 批准号: 10576710
• 负责人: BARBARA DRIVER
• 金额: $ 146.64万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-12 至 2024-11-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10576710
• 关键词: Address; Adolescence; Adolescent; Antibodies; Behavioral; Birth; Brazil; Child; Childhood; Clinical; Clinical Trials; Cohort Studies; Collection; Communicable Diseases; Comparative Study; Contractor; Country; Cytomegalovirus; Data; Data Analyses; Data Set; Databases; Development; Disease; Enrollment; Environmental Exposure; Environmental Impact; Feasibility Studies; Fetal Development; Future; Goals; Growth and Development function; HIV; Incidence Study; Individual; Infant; Infant Development; Infection; Intellectual functioning disability; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigation; Knowledge; Laboratories; Manuscripts; Medical; Mission; Monitor; Morbidity - disease rate; National Institute of Child Health and Human Development; Outcome; Participant; Phase; Placenta; Postpartum Women; Pregnancy; Pregnant Women; Prevention; Prospective cohort; Protocols documentation; Psyche structure; Publications; Puerto Rico; Reporting; Research; Research Support; Risk; Sample Size; Sampling; Science; Site; Specimen; United States; United States National Institutes of Health; Viral Load result; Virus Diseases; Visit; Woman; ZIKA; ZIKV infection; Zika Virus; adverse outcome; clinical research site; co-infection; cohort; comorbidity; data cleaning; design; immunogenicity; infancy; knowledge base; meetings; mortality; offspring; patient population; pregnant; prevent; prospective; research and development; Address; Adolescence; Adolescent; Antibodies; Behavioral; Birth; Brazil; Child; Childhood; Clinical; Clinical Trials; Cohort Studies; Collection; Communicable Diseases; Comparative Study; Contractor; Country; Cytomegalovirus; Data; Data Analyses; Data Set; Databases; Development; Disease; Enrollment; Environmental Exposure; Environmental Impact; Feasibility Studies; Fetal Development; Future; Goals; Growth and Development function; HIV; Incidence Study; Individual; Infant; Infant Development; Infection; Intellectual functioning disability; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigation; Knowledge; Laboratories; Manuscripts; Medical; Mission; Monitor; Morbidity - disease rate; National Institute of Child Health and Human Development; Outcome; Participant; Phase; Placenta; Postpartum Women; Pregnancy; Pregnant Women; Prevention; Prospective cohort; Protocols documentation; Psyche structure; Publications; Puerto Rico; Reporting; Research; Research Support; Risk; Sample Size; Sampling; Science; Site; Specimen; United States; United States National Institutes of Health; Viral Load result; Virus Diseases; Visit; Woman; ZIKA; ZIKV infection; Zika Virus; adverse outcome; clinical research site; co-infection; cohort; comorbidity; data cleaning; design; immunogenicity; infancy; knowledge base; meetings; mortality; offspring; patient population; pregnant; prevent; prospective; research and development

The HIV ZIP study completed enrollment of 200 pregnant women (174 HIV infected and 26 HIV uninfected) and 195 of their offspring who resided in the United States, Puerto Rico, and Brazil. For study completion, the primary study tasks relate to supporting study monitoring activities through the last participant visit, data cleaning, and data analysis. The last maternal delivery visit for HIV ZIP occurred in June 2019, and the last participant (infant) visit occurred in September 2020. Data cleaning of the final datasets and database lock were completed on December 30, 2020. Delivery of the final dataset to the study statisticians occurred on January 20, 2021. HIV ZIP was a feasibility study of a prospective international cohort of pregnant women and their infants from those pregnancies. Its goals were to evaluate the feasibility of a comparative study of the incidence of Zika virus (ZIKV) infection among pregnant women with and without Human Immunodeficiency Virus (HIV) infection and to determine the risk of adverse outcomes associated with ZIKV/HIV co-infection across clinical sites in the continental United States (U.S.), Puerto Rico (P.R.), and Brazil. The study was designed to (1) determine the feasibility of satisfactorily achieving accrual targets, (2) confirm the adequacy of statistical assumptions for power and sample size considerations for a future large scale study in this patient population, and (3) provide adequate statistical power to detect clinical meaningful differences in the proportions of HIV-infected women with unsuppressed HIV viral load between HIV-infected women with Zika and HIV-infected women without Zika infection, assuming 10% of the HIV-infected women enrolled (and meeting Zika risk criteria) have ZIKV infection by delivery. The primary study analysis of producing a report that addresses each of the topics enumerated above could not be fulfilled because Phase I’s feasibility objective was not achieved (i.e., to enroll at least 10% of women who were co-infected with HIV and Zika). Nevertheless, the protocol team developed numerous research concepts that align with the other primary and secondary study objectives. These research concepts address HIV treatment and disease parameter comparisons between pregnant women living with HIV in Brazil and the U.S., general and ART-related developmental outcomes on infants, the impact of environmental exposures on birth outcomes among women living with HIV, cytomegalovirus shedding in HIV-infected women and infant development outcomes, and the immunogenicity of Tdap in HIV-infected pregnant women and passively acquired antibodies in their infants.

HIV拉链研究完成了200名孕妇的入学人数（174名HIV感染和26名HIV 未感染的）和195名居住在美国，波多黎各和巴西的后代。为了 研究完成，主要的研究任务与支持研究监测活动有关 最后一次参与者访问，数据清洁和数据分析。 HIV拉链的最后一次主要分娩访问 发生在2019年6月，最后一次参加（婴儿）访问发生在2020年9月。 最终数据集和数据库锁定于2020年12月30日完成。 研究统计学家的数据集发生在2021年1月20日。 艾滋病毒拉链是一项可行性的研究 这些怀孕的婴儿。它的目标是评估比较研究的可行性 有和没有人类的孕妇的寨卡病毒（ZIKV）感染的发病率 免疫缺陷病毒（HIV）感染，并确定与 ZIKV/HIV共同感染了美国连续临床部位（美国），波多黎各（P.R.）和 巴西。 该研究的设计为（1）确定令人满意实现振荡目标的可行性，（2） 确认统计假设对功率和样本量考虑的充分性，以后 该患者人群的大规模研究，（3）提供足够的统计能力来检测临床 未受抑制的HIV病毒负荷的艾滋病毒感染妇女比例的有意义的差异 假设有10％ 在招收的艾滋病毒感染的妇女中（并满足寨卡风险标准）通过分娩感染了zikv感染。 生产报告的主要研究分析，该报告涉及上述每个主题 无法实现，因为没有实现I期的可行性目标（即至少注册10％ 尽管如此，协议小组成立了与艾滋病毒和Zika共同感染的妇女。 许多与其他主要和二级研究目标保持一致的研究概念。这些 研究概念涉及孕妇的艾滋病毒治疗和疾病参数比较 在巴西和美国享有艾滋病毒的妇女，一般和艺术有关的发展成果 婴儿，环境暴露对艾滋病毒妇女的出生结果的影响， 艾滋病毒感染妇女和婴儿发育结果的巨细胞病毒脱落，以及 TDAP的免疫原性在感染HIV的孕妇中，并在其中被动获得抗体 婴儿。