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

南非医学研究委员会临床试验单位 (MRC CTU)

• 批准号: 8784151
• 负责人: GITA RAMJEE
• 金额: $ 27.02万
• 依托单位: MEDICAL RESEARCH COUNCIL OF SOUTH AFRICA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8784151
• 关键词: AIDS prevention; Address; Adherence; Adult; African; Area; Barrier Contraception; Behavioral; Behavioral Research; Caring; Clinical Research; Clinical Trials; Clinical Trials Unit; Communities; Comorbidity; Couples; Data; Development; Diagnostic; Drug Formulations; Drug resistance; Drug resistance in tuberculosis; Effectiveness; Epidemic; Failure; Future; Goals; HIV; HIV prevention trial; HIV vaccine; Health Personnel; Healthcare; Home environment; Incidence; Individual; International; Intervention; Knowledge; Link; Medical Research; Molecular; Multi-Drug Resistance; Nucleosides; Oral; Outcome; Participant; Pharmaceutical Preparations; Phase; Policies; Policy Maker; Population; Populations at Risk; Prevention; Prevention strategy; Prophylactic treatment; Protease Inhibitor; RNA-Directed DNA Polymerase; Randomized Controlled Trials; Regimen; Research; Research Infrastructure; Reverse Transcriptase Inhibitors; Risk; Risk Factors; Science; Site; South Africa; Testing; Therapeutic; Therapeutic Agents; Therapeutic Trials; Training; Treatment Protocols; Vaccines; Vaginal Diaphragm; base; behavioral study; clinical research site; co-infection; cost effective; efficacy trial; experience; innovation; meetings; men; microbicide; novel; operation; pandemic disease; prevent; programs; response; socioeconomics; success; therapy duration; treatment duration; treatment program; tuberculosis treatment; vaccine efficacy; vaccine evaluation; vaccine safety; vaccine trial; young woman

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. RELEVANCE: This comprehensive attempt to address the dual HIV/TB pandemic in Durban, South Africa through an integrated approach of testing novel HIV prevention strategies, novel HIV therapeutics agents for future options, and addressing HIV co-morbidity with TB with appropriate linkage to care, will provide the empirical data to guide future real-world development and implementation of effective HIV and TB strategies.

描述（由申请人提供）：南非夸祖鲁纳塔尔省德班是全球艾滋病毒大流行的中心，那里大量艾滋病毒感染者同时感染结核病。 MRC 临床试验单位 (MRC CTU) 因开展大规模 HIV 预防试验而享誉国际，其中包括杀菌剂、阴道隔膜和口服暴露前预防 (PrEP)； HIV 治疗试验和社会行为研究。 六个完善的临床研究中心 (CRS) 位于大德班地区，该地区年轻女性的艾滋病毒发病率从 5.1/100PY（早期研究）到 16.4/100PY（2012 年）不等。 早期试验缺乏有效性是由于多种因素造成的，其中包括依从性差。 目前对该流行病的了解表明，需要采取综合方法来预防、治疗艾滋病毒和结核病并与护理联系起来。 MRC CTU 的主要目标是通过与 4 Networks 合作，整合现场运营、社区合作伙伴关系以及对依从性挑战/行为研究的应对，以实现以下目标： 目标 1：在高危人群中进行长效杀菌剂和口服 PrEP 和 HIV 疫苗的 HIV 预防试验。 我们假设，针对这一人群的长效制剂可能会规避依从性挑战。 目标 2：进行新颖、安全、有效和稳健的治疗方案的治疗试验。 我们假设在可预见的将来我们将需要具有成本效益的三线治疗方案。 目标 3：开展 HIV 相关合并症的随机对照试验。 我们建议通过开发和参与使用分子诊断的试验来解决结核病治疗中存在的关键差距，以确定治疗持续时间并优化耐多药结核病的药物治疗方案。 目标 4：应对疫情的综合策略。 没有任何单一的艾滋病毒预防方案可以解决这一流行病。 我们希望参与测试艾滋病毒预防综合策略以及整合策略的试验 预防和治疗艾滋病毒和结核病，并与护理有效联系。 MRC CTU 可以接触高危人群、完善且集中的 CRS 基础设施以及国际顾问的经验和专业知识，以承担和实现拟议的研究目标。 相关性：这一全面尝试通过测试新的艾滋病毒预防策略、新的艾滋病毒治疗剂以供未来选择，以及通过适当的护理联系解决艾滋病毒与结核病的共病问题，解决南非德班的艾滋病毒/结核病双重流行问题，将为指导未来现实世界中有效的艾滋病毒和结核病战略的制定和实施提供经验数据。