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提议成立 JHU 南亚临床试验中心，首席研究员 David D. Celentano。该 CTU 重点招募注射吸毒者 (IDU) 和受艾滋病毒/艾滋病流行影响的高危亚洲人群，进入 IIb 期和 III 期临床试验，研究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中心 (CRS) 组成。在泰国北部，我们提议建立一组研究中心，由清迈大学 (CMU) 健康科学研究所 (RIHES) 领导（中心负责人 Thira Sirisanthana）。在印度南部，我们提议在钦奈的 YR Gaitonde 药物滥用相关研究中心 (YRG CSAR) 设立一个研究地点（Suniti Solomon，地点负责人）。我们与这两个单位有着长期的研究合作，并且一直是过去 HPTN 研究的合作者。三项 HPTN 研究正在清迈现场进行，并将持续到本自由亚洲电台期间。 HPTN 037 是一项 III 期行为研究，旨在研究社交网络干预措施在注射吸毒者中预防艾滋病毒感染的效果，于 2004 年 3 月在清迈启动；该网站的招募目标是1,740名志愿者；我们建议将招生范围扩大到钦奈站点。 HPTN 043 是一项 III 期研究，旨在研究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的有效性，目前正在泰国北部的 14 个社区进行。这项研究主要由 NIMH 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 IND 临床试验，旨在研究抗逆转录病毒治疗在减少不和谐夫妇中艾滋病毒性传播的功效，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 预计将从清迈开始，并于明年扩展到金奈。这是一项 III 期 IND 临床试验，旨在探讨丁丙诺啡/纳洛酮阿片类药物替代疗法预防 HIV 感染的功效。 行政部分：

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: