SOUTH AFRICA MRC HIV PREVENTION TRIALS UNIT

描述（改编自申请人的摘要）：拟议的南非 MRC HPTU将包括一个具有以下研究能力的跨学科团队： 杀微生物剂、围产期艾滋病毒传播和性病控制，以及 免疫学、传染病、流行病学、生物统计学、行为 科学、临床试验管理和社区动员。 正在进行 该团队的杀微生物剂研究包括PRO 2000/5的I期试验， PC-515的II期试验和COL-1492的III期试验。 围产期艾滋病毒 这一群体的研究重点是母乳喂养传播， 正在评估干预措施，包括延长奈韦拉平的使用， 母乳喂养期间的预防。 改善性病护理以减少艾滋病毒 传播正在一个以社区为基础的生态水平的试验中进行测试， Hlabisa，初步数据表明有益的效果。 的研究人员 该HPTU在进行试验方面有着丰富的经验，特别是艾滋病毒 预防试验（一年随访率平均为85- 95%）。 申请人提出了一系列新的和现有的队列，包括（1）1，000 年轻的Hlabisa妇女（艾滋病毒发病率=每年14.8%）， IIb/III杀微生物剂试验，（2）来自三家医院的2 000对母婴 在德班（艾滋病毒流行率= 32%，垂直传播率= 28 （3）第一阶段，来自RK Khan医院的120名低风险妇女 杀微生物剂试验，（4）12个社区的性病干预试验，和（5） 100对不和谐夫妇和400名性工作者（艾滋病毒感染率= 18.2%）进行暴露后预防试验。 自从这个网站 领导HIVNET资助的两项I期试验的方案（PRO2000/5杀微生物剂 和奈韦拉平），它可以扩展到IIb期或 III试验，以评估这些干预措施的有效性。 阶段I和阶段 在南非MRC HPTU中，II能力得到了很好的发展， 还计划在大规模的高危人群中进行III期临床试验。 计划包括征聘和后续行动，在某些情况下将使用全球 定位技术，以帮助定位对象。 社区筹备工作 艾滋病毒疫苗试验处于后期阶段;社区咨询委员会 已经建立了社区教育计划， 切实贯彻 除了关于艾滋病毒预防干预措施的新想法外， 南非MRC HPTU拥有完善的临床试验能力， 在行为、道德和社区准备方面做出贡献的计划 艾滋病预防研究。

DESCRIPTION (adapted from applicant's abstract): The proposed South African MRC HPTU would comprise a transdisciplinary team with research capabilities in microbicides, perinatal HIV transmission, and STD control, and expertise in immunology, infectious diseases, epidemiology, biostatistics, behavioral science, clinical trial management, and community mobilization. Ongoing microbicide research within the team includes a Phase I trial of PRO2000/5, a Phase II trial of PC-515, and a Phase III trial of COL-1492. Perinatal HIV research within this group focuses on breastfeeding transmission, and new interventions are being assessed including the extended use of nevirapine as prophylaxis during breastfeeding. Improving STD care to reduce HIV transmission is being tested in a community-based ecological-level trial in Hlabisa, with preliminary data suggesting a beneficial effect. Researchers in this HPTU have extensive experience in the conduct of trials, especially HIV prevention trials (with one-year follow-up rates averaging 85-95 percent). The applicant proposes a range of new and existing cohorts including (1) 1,000 young Hlabisa women (HIV incidence rate = 14.8 percent per year) for a Phase IIb/III microbicide trial, (2) 2,000 mother-infant pairs from three hospitals in Durban (HIV prevalence = 32 percent and vertical transmission rate = 28 percent in 1998), (3) 120 low-risk women from RK Khan hospital for Phase I microbicide trials, (4) 12 communities for a STD intervention trial, and (5) a cohort of 100 discordant couples and 400 sex workers (HIV incidence rate = 18.2 percent per year) for a post-exposure prophylaxis trial. Since this site leads protocols for two HIVNET-funded Phase I trials (PRO2000/5 microbicide and nevirapine during breastfeeding), it could expand to Phase IIb or Phase III trials to assess the efficacy of these interventions. Phase I and Phase II capabilities are well developed in the South African MRC HPTU, and the unit also plans to conduct Phase III trials in large, very high-risk cohorts. Plans include recruitment and follow-up, and in some instances will use global positioning technology to assist in locating subjects. Community preparations for HIV vaccine trials are at an advanced stage; Community Advisory Boards have been established and community education plans are already being implemented. In addition to new ideas on HIV prevention interventions and well-developed clinical trial capability, the South African MRC HPTU also plans to contribute to behavioral, ethical, and community preparation aspects of HIV prevention research.