South African Medical Research Council Clinical Trials Unit (MRC CTU)

描述（由申请人提供）：南非夸祖鲁纳塔尔的德班是全球艾滋病大流行的中心，大量艾滋病病毒感染者同时感染结核病。MRC临床试验单位（MRC CTU）是国际知名的艾滋病毒预防，包括杀微生物剂，阴道隔膜和口服暴露前预防（PrEP）进行大规模试验;艾滋病毒治疗试验，和社会行为研究。大德班地区有六个完善的临床研究中心（CRS），年轻女性的艾滋病毒发病率从5.1/100 PY（早期研究）到16.4/100 PY（2012年）不等。早期试验缺乏有效性是由于多种因素，包括依从性差。目前对这一流行病的认识表明，需要对艾滋病毒和结核病的预防、治疗以及与护理的联系采取综合办法。MRC CTU的主要目标是通过与4个网络合作，整合现场运营，社区合作伙伴关系以及对依从性挑战/行为研究的响应，以实现以下目标：目的1：在高危人群中进行长效杀微生物剂和口服PrEP和HIV疫苗的HIV预防试验。我们假设，长效制剂在这一人群中可能会规避依从性的挑战。目的2：进行新的，安全的，有效的和强大的方案的治疗试验。我们假设，在可预见的将来，在我们的环境中，将需要成本效益高的三线治疗方案。目的3：开展HIV相关合并症的RCT。我们建议通过开发和参与使用分子诊断的试验来确定治疗持续时间并优化耐多药结核病的药物方案来解决结核病治疗方面的关键差距。目标4：应对艾滋病的综合战略。任何单一的艾滋病毒预防办法都无法解决这一流行病。我们希望参与测试艾滋病毒预防综合战略的试验， 预防和治疗艾滋病毒和结核病，并与护理有效联系。MRC CTU可以接触到高危人群，拥有发达和集中的CRS基础设施，以及国际顾问的经验和专业知识，以开展和实现拟议的研究目标。

DESCRIPTION (provided by applicant): Durban, KwaZulu Natal, South Africa is the epicenter of the global HIV pandemic, where a large number of people infected with HIV are also co-infected with TB. The MRC Clinical Trials Unit (MRC CTU) is internationally renowned for conducting large scale trials of HIV prevention including microbicides, vaginal diaphragm, and oral Pre-Exposure Prophylaxis (PrEP); HIV therapeutic trials, and socio-behavioral studies. Six well-established clinical research sites (CRSs) are located in the greater Durban area, where HIV incidence among young women ranges from 5.1/100PY (in earlier research) to 16.4/100PY (in 2012). Lack of effectiveness in earlier trials was due to multiple factors, including poor adherence. The current understanding of the epidemic suggests a need for an integrated approach to HIV and TB prevention, treatment, and linkage to care. The MRC CTU's primary goal is to integrate site operations, community partnerships, and responses to adherence challenges/behavioral research by partnering with 4 Networks to meet the following aims: AIM 1: Conduct HIV prevention trials of long-acting microbicides and oral PrEP and HIV vaccines in at-risk populations. We hypothesize that long-acting formulations in this population may circumvent adherence challenges. AIM 2: Conduct therapeutic trials of novel, safe, effective, and robust regimens. We hypothesize that cost-effective, third-line treatment regimens will be needed in the foreseeable future in our setting. AIM 3: To undertake RCTs of HIV-associated co-morbidities. There are critical gaps in TB treatment that we propose to address by developing and participating in trials using molecular diagnostics to determine treatment duration and optimize drug regimens for multidrug-resistant TB. AIM 4: Integrated strategies to address the epidemic. No single HIV prevention option will address the epidemic. We hope to participate in trials testing integrated strategies of HIV prevention, as well as those integrating prevention and treatment of both HIV and TB, with effective linkage to care. The MRC CTU has access to the population at-risk, a well-developed and centralized CRS infrastructure, and the experience and expertise of international consultants to undertake and deliver on the proposed research aims.