HIV Centers for Underrepresented Populations in Research Clinical Trials Unit (CURE CTU)

研究临床试验单位中代表性不足人群的艾滋病毒中心 (CURE CTU)

• 批准号: 10532788
• 负责人: STEPHEN A SPECTOR
• 金额: $ 214.95万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10532788
• 关键词: AIDS clinical trial group; Acceleration; Address; Adolescence; Adolescent; Adolescent and Young Adult; Affect; Age; Aging; Anti-Retroviral Agents; Area; Behavioral; Biological; California; Cardiovascular Diseases; Characteristics; Chicago; Child; Childhood; Clinical Research; Clinical Trials; Clinical Trials Unit; County; Disease remission; District of Columbia; Drug Combinations; Early identification; Elderly; Enrollment; Epidemic; Evaluation; Fetal Development; Funding; Geographic Locations; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV-infected adolescents; Health Benefit; Health Sciences; Hepatitis B; Hepatitis B Virus; Hormonal Change; Immune response; Immune system; Infant; Infant Health; Infection; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Licensure; Maternal Health; Medical center; Medicine; Mental Health; Mental disorders; Metabolic; Methods; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Neurologic; Neuropsychology; Nutritional; Obesity; Opiate Addiction; Outcome; Pediatric Hospitals; Persons; Physiological; Population; Postpartum Women; Pregnancy; Pregnant Women; Prevention; Prevention strategy; Principal Investigator; Quality of life; Race; Research; Risk; Safety; Saint Jude Children' s Research Hospital; Sexually Transmitted Diseases; Site; System; Target Populations; Technology; Tennessee; Texas; Underrepresented Populations; Universities; Vaccination; Viral; Virus Diseases; Washington; Woman; Youth; anti-viral efficacy; clinical research site; co-infection; college; comorbidity; design; drug distribution; ethnic difference; ethnic diversity; ethnic minority; experience; improved; medication safety; neutralizing antibody; novel; pre-exposure prophylaxis; prevent; racial difference; racial minority; recruit; response; social; therapy design; transmission process; user-friendly; young adult; young woman

The HIV Centers for Underrepresented Populations in Research Clinical Trials Unit (CURE CTU) will be comprised of five highly experienced and successful Clinical Research Sites (CRS) within the continental U.S. and a sixth new CRS located at Children’s National Medical Center in Washington, DC. Each of the CRSs has >20 years of experience conducting clinical research in pregnant women, infants, children, adolescents and young adults with and at-risk for HIV infection. Each of the HIV CURE CRSs is located in one of 48 counties or in Washington DC, geographic locations that have been targeted by the U.S. President’s initiative to end the HIV epidemic. The CURE CTU management is located at the University of California San Diego; Dr. Stephen A. Spector will serve as the Principal Investigator. The six CRSs are located at Baylor College of Medicine/Texas Children’s Hospital in Houston, TX, Ann & Robert H. Lurie Children’s Hospital of Chicago, IL, Northwestern University, St. Jude Children’s Research Hospital and the University of Tennessee Health Science Center in Memphis, TN, University of Miami, Holtz Children’s Hospital, Miami, FL, Children’s National Medical Center in Washington, DC, and the University of California, San Diego, CA. The CURE CTU is the only unit specifically focused on research in pregnant women, women, children, adolescents and young adults less than 25 years in the continental U.S. funded through NIAID. The Specific Aims address many of the targeted high priority areas of the four NIAID proposed Networks. Aim 1: Identify novel and durable interventions to reduce reservoirs and control HIV replication in the absence of ART (ART- free remission) (ACTG Aim 1 and IMPAACT Aim 2). Aim 2: Advance ART of pregnant and postpartum women with HIV, to optimize maternal and infant health outcomes, and accelerate the evaluation (PK, safety, antiviral efficacy), licensure and optimal use of potent and durable ARVs for pregnant women, infants, children and adolescents with HIV (IMPAACT Aim 1). Aim 3: Design and conduct studies of broadly neutralizing antibodies (bnAbs), alone and in combination, and long-acting antiretroviral agents and delivery systems for pre-exposure prophylaxis (PrEP) (ACTG Aim 2, HPTN Aim 1, IMPAACT Aim 1). Aim 4: To investigate vaccination of HIV- exposed and unexposed infants to induce broad immune responses including broadly neutralizing antibody (HVTN Aim 4). Specific Aim 5: Design and conduct studies to evaluate multipurpose prevention technologies that concurrently prevent HIV and pregnancy, sexually transmitted infections or opioid dependence (HPTN Aim 2). Aim 6: Determine optimal and feasible methods for the prevention and management of complications and co-infections of HIV infection and their treatment in infants, children, adolescents and pregnant and postpartum women (IMPAACT Aim 4). Aim 7: Prevent or improve the treatment of HIV-related non-infectious co- morbidities and evaluate strategies to cure hepatitis B virus infection in people with/without HIV (ACTG Aim 4, HVTN Aim 1).

研究临床试验单元（CURE CTU）中代表性不足的HIV中心将是 在美国连续TALTAL中完成了五个经验丰富且成功的临床研究地点（CRS） 以及位于华盛顿特区儿童国家医疗中心的第六个新CRS。每个CRS都有 >在孕妇，婴儿，儿童，青少年和 患有艾滋病毒感染的年轻人和高危人。每个HIV治疗CRS都位于48个县之一或 在华盛顿特区，美国总统倡议的目标是结束 艾滋病毒流行。 CURE CTU管理位于加利福尼亚大学圣地亚哥分校；斯蒂芬博士 A. Spector将担任首席研究员。六个CRS位于贝勒学院 德克萨斯州休斯敦的医学/德克萨斯儿童医院，伊利诺伊州芝加哥的安和罗伯特·H·罗伯特·H·罗伯特·H·罗伯特·H·罗伯特 西北大学，圣裘德儿童研究医院和田纳西大学健康 田纳西州孟菲斯的科学中心，迈阿密大学，霍尔茨儿童医院，迈阿密，佛罗里达州儿童国家 华盛顿特区的医学中心和加利福尼亚州圣地亚哥分校的加利福尼亚大学。治愈CTU是 仅专门针对孕妇，妇女，儿童，青少年和 通过NIAID资助的美国大陆的年轻人不到25年。具体目标 解决了四个NIAID提议的网络的许多有针对性的高优先级领域。目标1：识别 在没有艺术的情况下减少储层和控制艾滋病毒复制的新颖和耐用的干预措施（艺术 自由缓解）（ACTG AIM 1和INCACT AIM 2）。目标2：预先孕妇和产后妇女的艺术 使用艾滋病毒，以优化母亲和婴儿的健康结果，并加速评估（PK，安全，抗病毒 效率），对孕妇，婴儿，儿童和 患有艾滋病毒的青少年（不可能的目标1）。目标3：设计和进行广泛中和抗体的研究 （bnabs），单独和组合，长效抗逆转录病毒药物和用于暴露前的递送系统 预防（PREP）（ACTG AIM 2，HPTN AIM 1，INCACT AIM 1）。目标4：研究HIV的疫苗接种 - 暴露和意外的婴儿诱导广泛的免疫反应，包括广泛中和抗体 （HVTN AIM 4）。特定目的5：设计和进行研究以评估多用途预防技术 同时预防艾滋病毒和怀孕，性传播感染或阿片类药物依赖性（HPTN AIM） 2）。目标6：确定预防和管理并发症的最佳和可行方法 艾滋病毒感染的共同感染及其在婴儿，儿童，青少年以及孕妇和产后的治疗 妇女（Incract Aim 4）。 AIM 7：防止或改善与HIV相关的非感染性共同治疗 病毒性并评估治愈患有艾滋病毒患者乙型肝炎病毒感染的策略（ACTG AIM 4， HVTN AIM 1）。