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地推荐JHU南亚临床试验小组，David D. Celentano，首席研究员。该CTU的重点是招募注射吸毒者（IDU）和受艾滋病毒/艾滋病流行影响的高风险亚洲人群参加研究预防艾滋病毒感染新策略的ii期和III期临床试验。我们将讨论艾滋病规划署在其RFA-AI-05-002中确定的两个高度优先的临床研究领域：预防艾滋病毒感染和杀微生物剂。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和泰国北部和印度南部的临床研究基地（CRS）组成。在泰国北部，我们提议由清迈大学（CMU）健康科学研究所（RIHES） （Thira Sirisanthana，基地负责人）领导的研究基地集群。在印度南部，我们建议在金奈的YR Gaitonde药物滥用相关研究中心（YRG CSAR）建立一个研究地点（苏尼提·所罗门，该研究地点负责人）。我们与这两个单位都有长期的研究合作，并且一直是过去HPTN研究的合作者。目前正在清迈场址进行三项HPTN研究，并将持续到本区域会议期间。HPTN 037是一项关于社会网络干预预防注射吸毒者感染艾滋病毒效果的第三期行为研究，于2004年3月在清迈开始；该网站的招募目标是1740名志愿者；我们建议将招生扩大到金奈站点。HPTN 043是一项基于社区的自愿咨询和检测在社区一级预防艾滋病毒感染有效性的三期研究，目前正在泰国北部的14个社区开展。这项研究在很大程度上得到了NIMH的支持，但由HPTN开发；基线调查于2005年1月开始，干预措施于2005年9月开始。HPTN 052是一项III期临床试验，旨在研究抗逆转录病毒治疗在减少不和谐夫妇之间性传播艾滋病毒方面的疗效，该试验于2005年6月在清迈开始，招募目标为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。这是一项用丁丙诺啡/纳洛酮替代阿片类药物治疗预防HIV感染疗效的III期IND临床试验。

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: