Stellenbosch University Clinical Trials Unit

项目摘要 南非拥有世界上最大的抗逆转录病毒疗法治疗项目和第二高的结核病 结核病是传染性病原体导致死亡的主要原因。南非跻身前十 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部门 位于南非开普敦的SUN-CTU是一个成熟的、多能的、高能力的研究伙伴关系 三个临床研究中心（CRS）之间：家庭研究中心与Ubuntu（FAMCRU）， Desmond Tutu结核病中心（DTTC）和塔斯克基金会全国人民代表大会（塔斯克）， IMPAACT，ACTG，HPTN和HVTN网络研究的扩展。 SUN-CTU的总体目标是协同设计和实施高影响力的临床研究， 结果是安全的，以病人和家庭为中心的，有效的预防，治疗和缓解艾滋病毒及其相关疾病 合并症，结核病预防，诊断和治疗，在所有年龄组。 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将优先考虑 新的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 长期治疗并发症、抗逆转录病毒耐药性、结核病/艾滋病毒药物相互作用和促进治疗 坚持。我们将重点关注早期治疗的儿童和青少年的艾滋病毒缓解和神经发育 成人肝炎、巨细胞病毒合并感染和非传染性疾病、艾滋病毒相关神经认知功能障碍 残疾、心理健康和艾滋病毒持续存在。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 抗体（bnAbs），以及青少年和成人人群的暴露前预防。FAMCRU将 在婴儿、接触艾滋病毒但未受感染的儿童和青少年中开展艾滋病毒预防研究， 一系列干预措施，包括预防母婴传播、bnAb和艾滋病毒疫苗， 影响。ASK将进行艾滋病毒疫苗试验。最后，我们将处理结核病预防、诊断和治疗问题 所有年龄段的艾滋病毒感染者/非感染者：SUN-CTU是评估新型结核病和再利用结核病的理想场所 治疗和预防成人疾病谱的方案，包括耐药性和非耐药性 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 在特殊人群中进行的研究，包括住院重症患者，例如结核性脑膜炎。DTTC将引领 评估新的和重新利用的药物方案的方案，以治疗和预防药物敏感和药物敏感， 婴儿、儿童、青少年、孕妇和哺乳期妇女感染结核病但未感染艾滋病毒， 疾病PK研究的专门网站。

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.