Southern Asia HIV/AIDS Clinical Trials Unit

描述(由申请人提供)：约翰霍普金斯大学及其在泰国和印度的合作伙伴很高兴推荐JHU南亚临床试验单位，首席研究员David D.Celentano。这个CTU的重点是招募注射吸毒者(IDU)和受艾滋病毒/艾滋病疫情影响的高危亚洲人群，进入IIb和III阶段临床试验，调查预防艾滋病毒感染的新策略。我们将讨论DAIDS在其RFA-AI-05-002中确定的两个高度优先的临床研究领域：艾滋病毒感染的预防和杀菌剂。为了预防艾滋病毒感染，我们将加入拟议的艾滋病毒预防试验网络。JHU南亚CTU由约翰霍普金斯大学的行政部门以及泰国北部和印度南部的临床研究地点(CRS)组成。在泰国北部，我们提议建立一个由清迈大学(CMU)健康科学研究所(RIHES)领导的研究站点群(站点负责人Thira Sirisanthan a)。在印度南部，我们建议在金奈的YR Gaitonde物质滥用相关研究中心(YRG CSAR)建立一个研究网站(网站负责人苏尼提·所罗门)。我们与这两个单位都有长期的研究合作，并在过去的HPTN研究中一直是合作者。目前，清迈遗址正在进行三项关于HPTN的研究，并将继续进行到本区域论坛期间。HPTN 037是一项关于社会网络干预在预防注射吸毒者感染艾滋病毒方面的有效性的第三阶段行为研究，于2004年3月在清迈开始；该网站的招募目标是1,740名志愿者；我们建议扩大金奈网站的注册人数。HPTN 043是关于社区自愿咨询和检测在社区一级预防艾滋病毒感染的有效性的第三阶段研究，目前正在泰国北部的14个社区进行。这项研究在很大程度上得到了NIMH的支持，但由HPTN制定；基线调查始于2005年1月，干预措施始于2005年9月。HPTN 052是一项第三阶段的IND临床试验，研究抗逆转录病毒治疗在不和谐夫妇中减少艾滋病毒性传播的有效性，于2005年6月在清迈开始，现场登记目标为243对夫妇。正在开发的第四个HPTN协议HPTN 058预计将在清迈开始，并于明年扩展到金奈。这是一项关于丁丙诺啡/纳洛酮阿片类药物替代疗法预防HIV感染疗效的第三阶段IND临床试验。 管理组件：

DESCRIPTION (provided by applicant): Johns Hopkins University and its partners in Thailand and India are pleased to propose the JHU Southern Asia Clinical Trials Unit, David D. Celentano, Principal Investigator. This CTU focuses on recruiting injecting drug users (IDU) and high risk Asian populations affected by the HIV/AIDS epidemic, into phase IIb and III clinical trials investigating novel strategies to prevent HIV infection. We will address two of the high priority clinical research areas identified by DAIDS in its RFA-AI-05-002: Prevention of HIV Infection and Microbicides. For prevention of HIV infection we will affiliate with the proposed HIV Prevention Trials Network. The JHU Southern Asia CTU consists of an administrative component at Johns Hopkins and clinical research sites (CRS) in northern Thailand and southern India. In northern Thailand we are proposing a cluster of research sites led by the Research Institute for Health Sciences (RIHES) at Chiang Mai University (CMU) (Thira Sirisanthana, site leader). In southern India we propose a research site at the YR Gaitonde Center for Substance Abuse-related Research (YRG CSAR), Chennai (Suniti Solomon, site leader). We have longstanding research collaborations with both these units, and have been collaborators on past HPTN studies. Three HPTN studies are under way at the Chiang Mai site and will continue into the period this RFA. HPTN 037, a Phase III behavioral study of the efficacy of a social network intervention in preventing HIV infection among IDUs, began in Chiang Mai in March 2004; the site has a recruitment target of 1,740 volunteers; we propose expanding enrollment to the Chennai site. HPTN 043, a Phase III study of the effectiveness of community based voluntary counseling and testing to prevent HIV infection at a community level, is being carried out in 14 communities in northern Thailand. This study is largely supported by NIMH but was developed by the HPTN; the baseline survey began in January 2005, with interventions beginning in September 2005. HPTN 052, a Phase III IND clinical trial, of the efficacy of antiretroviral therapy in reducing sexual transmission of HIV among discordant couples, began in Chiang Mai in June 2005 with a site enrollment target of 243 couples. A fourth HPTN protocol under development, HPTN 058, is expected to begin in Chiang Mai, and expand to Chennai, in the next year. This is a Phase III IND clinical trial of the efficacy of opioid substitution therapy with buprenorphine/naloxone for prevention of HIV infection. ADMINISTRATIVE COMPONENT: