PACTG 1020-A (VERSION 20):PHASE I/II STUDY OF A NOVEL PROTEASE INHIBITOR IN HIV

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。过去几年中，在完成《行动纲领》当前议程和规划未来应对感染艾滋病毒的孕妇、儿童和青少年的挑战方面取得了重大进展。特别是，太平洋行动计划大大扩大了其应对措施，以应对在发展中世界治疗和预防艾滋病毒/艾滋病的挑战。全世界约有4 200万人感染艾滋病毒，其中300多万是儿童。在每天新增的1.6万例感染病例中，有2000例为15岁以下儿童，50%为15至25岁的青年。一半以上的艾滋病毒新感染者是妇女。在美国，围产期儿童感染已经从一种一成不变的致命疾病转变为一种慢性疾病，在过去的6年里，PACTG 219c跟踪了儿童的年死亡率<1%。此外，在美国，50%的新感染病例（约20,000例）发生在13至25岁的年轻人中，感染艾滋病毒的妇女生育第二和第三个孩子的人数比以往任何时候都多。虽然95%的新感染发生在发展中国家，但世界期待太平洋行动小组提供指导和领导，帮助制定控制和治疗并有朝一日预防和治愈艾滋病毒感染的方针。尽管国际上越来越重视艾滋病毒治疗和预防，但太平洋防治小组国内地点的重要性以及国内艾滋病毒研究在向国际社会提供领导方面发挥的作用怎么强调都不为过。事实上，目前几乎每一个国际临床试验项目要么直接通过太平洋临床试验小组的参与，要么间接地利用与太平洋临床试验小组密切合作的个人的专业知识，在其项目中预防艾滋病毒的围产期传播，并改善对感染艾滋病毒的儿童和青少年的治疗。一个强大和创新的国内PACTG为建立和维持国际临床试验基地奠定了基础。2004年，新纳入PACTG试验的受试者1424人，积极随访PACTG研究的受试者5226人。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The past years have been marked by substantial progress in accomplishing the current agenda of the PACTG and in planning for the future to meet the challenges of HIV infected pregnant women, children and adolescents. In particular, the PACTG has significantly broadened its response to meet the challenges of treating and preventing HIV/AIDS in the developing world. Of the approximately 42 million persons infected with HIV worldwide, more than 3 million are children. Of the 16,000 new infections daily, 2,000 are in children below 15 years and 50% are in youth between 15 and 25 years. More than half of new HIV infections occur in women. Within the U.S., perinatal infection of children has been altered from an invariably fatal disease to a chronic illness with <1% annual mortality of children followed in PACTG 219c over the past 6 years. Additionally, in the U.S., 50% of new infections (~20,000) occur in youth between 13 and 25 years of age, and more HIV-infected women are giving birth to second and third children than ever before. Although 95% of new infections occur in developing countries, the world looks to the PACTG for guidance and leadership in helping to set a course that will control and treat, and one day prevent and cure HIV infection. Despite the increased emphasis on international HIV treatment and prevention, the importance of the PACTG domestic sites, and the role that domestic HIV research plays in providing leadership to the international community cannot be overemphasized. In fact, almost every international clinical trials program currently works either directly through PACTG involvement or indirectly through tapping the expertise of individuals who work closely with the PACTG in their programs designed to prevent perinatal transmission of HIV, and to improve treatments for HIV-infected children and adolescents. A strong and innovative domestic PACTG forms the foundation from which to build and sustain international clinical trials sites. In 2004, 1,424 subjects were newly accrued into PACTG trials and a total of 5,226 subjects were actively followed in PACTG studies.