KARABELO Clinical Trials Unit for NIAID Networks

NIAID 网络的 KARABELO 临床试验单位

• 批准号: 9186496
• 负责人: Glenda E Gray
• 金额: $ 163.47万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9186496
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Adolescent; Adult; Adverse event; Africa South of the Sahara; Anti-Retroviral Agents; Area; Behavior Therapy; Breast Feeding; Cause of Death; Child; Cities; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Unit; Comorbidity; Counseling; Couples; Development; Diagnostic Procedure; Disease; Drug Formulations; Drug resistance in tuberculosis; Enrollment; Epidemiology; Evaluation; Female; Female Adolescents; Female Condoms; Funding; Government; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV/TB; Health; Hepatitis B; Heterosexuals; High Risk Woman; Hospitals; Human; Human immunodeficiency virus test; IMPAACT; Incidence; Individual; Infant; Infection; International; Intervention; Knowledge; Licensure; Local Microbicides; Long Island; Male Circumcision; Male Condoms; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; New York; Nomads; Oral; Participant; Pathogenesis; Persons; Phase; Population; Positioning Attribute; Pregnant Women; Prevalence; Prevention; Prevention strategy; Preventive Intervention; Proteins; Recruitment Activity; Regimen; Research; Resource Development; Resources; Risk; Scientist; Site; South Africa; Southern Africa; Testing; Therapeutic; Training; Translating; Tuberculosis Vaccines; United States National Institutes of Health; Vaccines; Vagina; Viral; Viral hepatitis; Woman; antiretroviral therapy; base; clinical efficacy; clinical research site; co-infection; efficacy evaluation; high risk; high risk population; improved; innovation; male; men who have sex with men; microbicide; mortality; novel; novel diagnostics; novel therapeutics; pathogen; pediatric human immunodeficiency virus infection; pregnant; prevent; racial and ethnic; racial diversity; safety study; transmission process; tuberculosis treatment; vaccine candidate; vaccine trial; viral resistance

DESCRIPTION (provided by applicant): Although significant advances have been made in the past 30 years in the understanding of HIV pathogenesis, there is still a need for development of effective antiretroviral therapy for the long-term management of HIV infection in infants, children and adults, as well as antiretroviral interventions to prevent HIV in women, who have the greatest burden of HIV in sub-Saharan Africa, children, in discordant couples, men who have sex with men and certain high risk heterosexual populations. With 1.9 million people receiving antiretroviral therapy in South Africa alone, further clinical problems related to durability of therapy, viral resistance and adverse events are emerging. Moreover, male circumcision, access to voluntary counseling and HIV testing, male and female condoms and other behavioral interventions are important components of governments' strategies to control HIV, new HIV Infections remain persistently high. Biomedical interventions are urgently required especially to protect women. Without an effective HIV vaccine, it is doubtful whether eradication of the HIV infection is feasible. TB/HIV co-infection adds significant morbidity and mortality to HIV infected infants, children and adults, and is the leading cause of death in South Africa. More potent, shorter and less toxic treatment for TB, to prevent TB, and to treat drug resistant TB are desperately needed. Our proposed KAREBELO CTU, comprises a group of internationally renowned scientists, the majority of whom are based in South Africa, are women, and come from diverse racial and ethnic backgrounds. Our eight Clinical Research Sites forming the KARABELO Clinical Trials Unit (CTU) are strategically positioned in areas of high HIV prevalence and Incidence and include informal settlements, maternity units, TB clinics and an MDR hospital, cities and migrant laborers to answer critical questions in the control and prevention of both HIV and TB. The CRSs, seven of which are in South Africa and one in Long Island, New York have capacity to address critical clinical research agendas of four selected NIAID Clinical Research networks: vaccines to prevent HIV infection; microbicides to prevent HIV infection; HIV/AIDS and HIV-associated infections in infants and maternal populations; and therapeutics for HIV/AIDS and HIV-associated infections and pathogens in adults. RELEVANCE: HIV and TB continue to be one of greatest threats to human health. Progress in understanding and managing HIV, although revolutionary, and translated into practice at an advanced rate, has not yet yielded an effective HIV vaccine, microbicide or cure. Similarly, despite advancements in TB management, an effective vaccine for TB remains elusive.

描述（由申请人提供）：尽管在过去 30 年里，对 HIV 发病机制的了解已经取得了重大进展，但仍然需要开发有效的抗逆转录病毒疗法来长期管理婴儿、儿童的 HIV 感染 以及针对撒哈拉以南非洲地区艾滋病毒负担最重的妇女、儿童、不和谐的夫妇、男男性行为者和某些高危异性恋人群的艾滋病毒抗逆转录病毒干预措施。仅在南非就有 190 万人接受抗逆转录病毒治疗，与治疗持久性、病毒耐药性和不良事件相关的进一步临床问题正在出现。此外，男性包皮环切术、获得自愿咨询和艾滋病毒检测、男用和女用安全套以及其他行为干预措施是政府控制艾滋病毒战略的重要组成部分，新发艾滋病毒感染率仍然居高不下。迫切需要生物医学干预措施，特别是为了保护妇女。如果没有有效的艾滋病毒疫苗，根除艾滋病毒感染是否可行值得怀疑。结核病/艾滋病毒混合感染显着增加了艾滋病毒感染者的发病率和死亡率 婴儿、儿童和成人，是南非的主要原因。迫切需要更有效、更短时间和毒性更低的结核病治疗方法、预防结核病和治疗耐药结核病。我们提议的 KAREBELO CTU 由一群国际知名科学家组成，其中大多数来自南非，是女性，来自不同的种族和民族背景。我们的 KARABELO 临床试验中心 (CTU) 的八个临床研究中心战略性地位于艾滋病毒流行率和发病率高的地区，包括非正规住区、妇产科、结核病诊所和耐多药医院、城市和外来务工人员，以回答艾滋病毒流行和发病率高的地区的关键问题。控制和预防艾滋病毒和结核病。 CRS（其中 7 个位于南非，1 个位于纽约长岛）有能力解决四个选定的 NIAID 临床研究网络的关键临床研究议程：预防 HIV 感染的疫苗；预防艾滋病毒感染的杀菌剂；婴儿和孕产妇群体中的艾滋病毒/艾滋病和艾滋病毒相关感染；以及成人艾滋病毒/艾滋病和艾滋病毒相关感染和病原体的治疗方法。 相关性：艾滋病毒和结核病仍然是人类健康的最大威胁之一。尽管在理解和管理艾滋病毒方面取得了革命性的进展，并以较高的速度转化为实践，但尚未产生有效的艾滋病毒疫苗、杀微生物剂或治疗方法。同样，尽管结核病管理取得了进步，但有效的结核病疫苗仍然难以找到。