Stellenbosch University Clinical Trials Unit

项目总结 南非拥有世界上最大的抗逆转录病毒治疗计划和第二高的结核病 发病率，结核病是传染病致死的主要原因。南非跻身前十名 艾滋病毒、结核病和耐药结核病负担高的国家。斯泰伦博斯大学临床试验中心 设在南非开普敦的SUN-CTU是一个成熟的、多潜能的、高能力的研究伙伴关系 在三个临床研究网站(CRSS)之间：家庭Ubuntu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网络的研究。 SUN-CTU的总体目标是协作设计和实施高影响力的临床研究， 导致安全、以患者和家庭为中心、有效地预防、治疗和缓解艾滋病毒及其相关疾病 所有年龄组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艾滋病毒治疗研究优先事项：FAMCRU将优先 所有年龄段的新抗逆转录病毒药物和其他干预措施的药代动力学和安全性，以最大限度地减少长期 长期治疗并发症、抗逆转录病毒耐药性、结核病/艾滋病毒药物-药物相互作用和促进治疗 坚持不懈。我们将重点关注艾滋病毒缓解和神经发育的早期治疗儿童和青少年 与成人肝炎、巨细胞病毒合并感染和非传染性疾病、艾滋病毒相关的神经认知 精神损害、精神健康和艾滋病毒的持久性。第二，我们将处理艾滋病毒预防研究的优先事项 所有年龄段的高危人群：通过HPTN，DTTC将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 青少年和成人人群中的抗体(BNAbs)和暴露前预防。FAMCRU将 在婴儿、接触艾滋病毒的未感染儿童和青少年中实施艾滋病毒预防研究，充分 一系列干预措施，包括预防母婴传播、bNAbs和艾滋病毒疫苗，通过 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 所有年龄段的艾滋病毒携带者/非HIV携带者：SUN-CTU是评估新的和改变用途的结核病的理想选择 成人耐药和不耐药的跨病谱治疗和预防方案 和艾滋病病毒。新的结核病重点领域包括成人结核病疫苗、肺外结核病、结核病后肺部疾病和PK 对特殊人群的研究，包括住院危重病人，例如肺结核脑膜炎。戴德梁行将领导 评估治疗和预防药物敏感和药物敏感的新的和重新调整用途的药物方案的方案。 未感染艾滋病毒的婴儿、儿童、青少年、孕妇和哺乳妇女中的耐药结核病包括 疾病PK研究的专门站点。

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.