Stellenbosch University Clinical Trials Unit

斯泰伦博斯大学临床试验单位

基本信息

批准号：
10304899
负责人：
Mark Fredric Cotton
金额：
$ 139.47万
依托单位：
STELLENBOSCH UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-04-15 至 2027-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10304899
关键词：
AIDS clinical trial group AIDS prevention Address Adjuvant Adolescent Adult Age Anti-Retroviral Agents Antiretroviral resistance Antitubercular Agents Area Aspirate substance Biological Markers Biopsy Breast Feeding Bronchial Lavages Cardiovascular Diseases Cause of Death Cerebrospinal Fluid Child Clinical Research Clinical Trials Unit Collaborations Competence Country Critical Illness Cytomegalovirus Diabetes Mellitus Diagnosis Diagnostic Disease Disease remission Drug Interactions Drug Kinetics Drug resistance Drug resistance in tuberculosis Drug user Family Formulation Foundations HIV HIV Seronegativity HIV Seropositivity HIV Vaccine Trials Network HIV vaccine HIV-infected adolescents HIV/TB Hepatitis Hepatitis B Image Immunology Incidence Infant Infectious Agent International Maternal Pediatric Adolescent AIDS Clinical Trials Intervention Kaposi Sarcoma Kidney Diseases Laboratories Lead Liver diseases Low Birth Weight Infant Lung Lung diseases Lymphoma Malignant Neoplasms Malignant neoplasm of cervix uteri Malignant neoplasm of lung Medical Meningeal Tuberculosis Mental Health Microbiology Modality Neurocognitive Deficit Nuclear Pore Complex Patients Persons Pharmaceutical Preparations Phase Population Positioning Attribute Pregnant Women Premature Infant Prevention Protocols documentation Pulmonary Tuberculosis Regimen Research Research Priority Resistance Risk Safety Sampling Site South Africa Special Population Sputum Structure of parenchyma of lung System Target Populations Technology The Sun Therapeutic Human Experimentation Treatment Protocols Tuberculosis Tuberculosis Vaccines Tuberculosis diagnosis Universities Vertical Disease Transmission Woman Youth age group aged antiretroviral therapy bactericide clinical research site co-infection comorbidity design drug repurposing family support high risk population immunogenicity interest lung health lymph nodes lymphadenopathy men who have sex with men neurodevelopment neutralizing antibody novel novel vaccines pre-exposure prophylaxis pregnant prevent safe patient safety study sex transgender treatment adherence treatment program treatment response tuberculosis drugs vaccine candidate vaccine trial

项目摘要

PROJECT SUMMARY South Africa has the world’s largest antiretroviral therapy treatment program and the second highest TB incidence, with TB the leading cause of death from an infectious agent. South Africa is amongst the top 10 countries with high burden of HIV, TB and drug-resistant TB. The Stellenbosch University Clinical Trials Unit (SUN-CTU) in Cape Town, South Africa is an established, pluripotent, high-capacity research partnership between three Clinical Research Sites (CRSs): the Family Centre for Research with Ubuntu (FAMCRU), the Desmond Tutu TB Centre (DTTC) and TASK Foundation NPC (TASK), ideally aligned for participation in IMPAACT, ACTG, HPTN and expansion to HVTN network studies. The overall SUN-CTU objective is to collaboratively design and implement high-impact clinical research that will result in safe, patient- and-family-centered, effective prevention, treatment and remission of HIV and its related comorbidities, and TB prevention, diagnosis, and treatment, across all age groups. The SUN-CTU aims to address HIV therapeutic research priorities across all ages: FAMCRU will prioritize pharmacokinetics and safety of new antiretrovirals and other interventions across all ages, to minimize long - term treatment complications, antiretroviral resistance, TB/HIV drug-drug interactions, and promote treatment adherence. We will focus on early treated children and adolescents for HIV remission and neurodevelopment and adult Hepatitis, CMV co-infection and non-communicable diseases, HIV-related neurocognitive impairment, mental health and HIV persistence. Second, we will address HIV prevention research priorities in high-risk populations across all ages: Through HPTN, the DTTC will design and implement HIV prevention studies and evaluate long-acting antiretrovirals, multipurpose prevention technologies, broadly neutralizing antibodies (bnAbs), and pre-exposure prophylaxis in adolescents and adults populations. FAMCRU will implement HIV prevention studies in infants, HIV-exposed uninfected children and adolescents, with the full range of interventions including prevention of mother to child transmission, bnAbs and HIV vaccines, through IMPAACT. TASK will conduct HIV vaccine trials. Finally, we will address TB prevention, diagnosis and treatment with/without HIV, across all ages: the SUN-CTU is ideally positioned to evaluate novel and repurposed TB regimens for treatment and prevention across the disease spectrum in adults, with and without drug resistance and HIV. New TB focus areas include adult TB vaccines, extrapulmonary TB, post-TB lung disease, and PK studies in special populations including hospitalized critically ill patients e.g. TB meningitis. DTTC will lead protocols to evaluate novel and repurposed drug regimens to treat and prevent drug-susceptible and drug- resistant TB in infants, children, adolescents, pregnant and breastfeeding women with TB without HIV including specialized site of disease PK studies.

项目概要南非拥有世界上最大的抗逆转录病毒疗法和第二高的结核病治疗计划发病率，结核病是南非传染病死亡的主要原因之一。艾滋病毒、结核病和耐药结核病负担较高的国家斯泰伦博斯大学临床试验中心。（SUN-CTU）位于南非开普敦，是一个成熟的、多能的、高能力的研究合作伙伴关系三个临床研究中心 (CRS) 之间：Ubuntu 家庭研究中心 (FAMCRU)、 Desmond Tutu 结核病中心 (DTTC) 和 TASK 基金会 NPC (TASK) 非常适合参与 IMPAACT、ACTG、HPTN 和扩展到 HVTN 网络研究。 SUN-CTU 的总体目标是合作设计和实施高影响力的临床研究，这些研究将从而实现安全、以患者和家庭为中心、有效的艾滋病毒及其相关疾病的预防、治疗和缓解所有年龄段的合并症以及结核病的预防、诊断和治疗。 SUN-CTU 旨在解决所有年龄段的 HIV 治疗研究优先事项：FAMCRU 将优先考虑新型抗逆转录病毒药物和其他干预措施在所有年龄段的药代动力学和安全性，以尽量减少长期 - 定期治疗并发症、抗逆转录病毒耐药性、结核病/艾滋病毒药物相互作用，并促进治疗我们将重点关注早期治疗的儿童和青少年，以实现艾滋病毒缓解和神经发育。和成人肝炎、CMV 合并感染和非传染性疾病、HIV 相关神经认知疾病其次，我们将解决艾滋病毒预防研究的优先事项。所有年龄段的高危人群：DTTC 将通过 HPTN 设计和实施艾滋病毒预防研究和评估长效抗逆转录病毒药物、多用途预防技术、广泛中和抗体（bnAbs），以及青少年和成人人群的暴露前预防。在婴儿、暴露于艾滋病毒的未感染儿童和青少年中开展艾滋病毒预防研究，并充分考虑一系列干预措施，包括预防母婴传播、bnAb 和 HIV 疫苗， IMPAACT.TASK 将进行艾滋病毒疫苗试验。最后，我们将解决结核病的预防、诊断和治疗问题。有/没有 HIV，所有年龄段：SUN-CTU 非常适合评估新型和重新利用的结核病针对成人各种疾病（无论有无耐药性）的治疗和预防方案新的结核病重点领域包括成人结核病疫苗、肺外结核病、结核病后肺病和药代动力学。针对特殊人群（包括住院重症患者，例如 DTTC）的研究将导致。评估新的和重新调整用途的药物治疗方案以治疗和预防药物敏感和药物- 患有结核病但未感染艾滋病毒的婴儿、儿童、青少年、孕妇和哺乳期妇女的耐药结核病，包括疾病 PK 研究的专门场所。