ADULT AIDS CLINICAL TRIALS UNIT

印第安纳大学建议在更新申请中建立在以下基础上：(1)科学和行政贡献。印第安纳州ACTU在科学上排名前20%；(2)成本效益应计纳入AACTG试验。印第安纳州在应计成本中排名第三；(3)招募妇女和少数民族。ACTU在招收非裔美国人方面排名第二，在招收女性方面排名第三。该网站的长期目标是：通过招募更多的调查人员来扩大科学和行政贡献；通过扩大Wishard医院分单位，增加妇女和少数民族的累积潜力；并通过在印第安纳波利斯社区医院建立一个亚单位来增加病人基数。印第安纳大学ACTU的第一个具体目标是通过提交概念提案和成为AACTG协议小组和委员会的成员，为科学做出贡献。目前，印第安纳州的调查人员在协议小组中有32个职位。提出了以下概念：(a)对依非韦伦无效的补救性治疗；(b)肛门发育不良的演变和HPV在HAART患者中的作用；(c) gp 120在HIV诱导的神经细胞凋亡中在痴呆发病机制中的作用；(d) GM-CSF和CD4配体对荚膜孢子虫和HIV-1免疫的作用；(e)药物与蛋白酶抑制剂相互作用的体外测定；(f)肠道代谢和抗逆转录病毒药物生物利用度的作用。第二个具体目标是扩大病人基础，包括妇女和少数民族，同时增加对Wishard医院和社区医院亚单位的支持。本申请中提出的工作将通过作为AACTG成员的临床试验来实施，使用作为ACTU在12年中完善的基础设施。专门的免疫学、病毒学和药理学实验室将支持这项工作。

The Indiana University proposes to build upon the following in the renewal application: (1) scientific and administrative contributions. The Indiana ACTU ranks among the top 20 percent of ACTUs scientifically; (2) cost efficient accrual into AACTG trials. Indiana ranked third in cost weighed accrual; and (3) recruitment of women and minorities. The ACTU ranked second in recruitment of African- Americans and third in women. The long-term objectives of this site are to: expand scientific and administrative contributions through recruitment of additional investigators; increase accrual potential for women and minorities by expansion of the Wishard Hospital subunit; and increase the patient base by establishing a subunit at Community Hospital of Indianapolis. The first specific aim of the Indiana University ACTU is to contribute scientifically through submission of concept proposals and memberships on AACTG protocol teams and committees. Currently, Indiana investigators hold 32 positions on protocol teams. Concepts are proposed for: (a) salvage therapy for efavirenz failures; (b) evolution of anal dysplasia and the role of HPV in patients on HAART; (c) the role of gp 120 in HIV induced apoptosis of neurological cells in pathogenesis of dementia; (d) the role of GM-CSF and CD4 ligand on immunity to H. Capsulatum and HIV-1; (e) use of in vitro assays for drug interactions with protease inhibitors; and (f) the role of intestinal metabolism and bioavailability of antiretroviral drugs. The second specific aim is to expand the patient base, including women and minorities, though increased support for subunits at Wishard Hospital and Community Hospital. The work proposed in this application will be implemented through conduct of clinical trials as a member the AACTG, using an infrastructure that has been refined during 12 years as an ACTU. Specialized immunology, virology, and pharmacology laboratories will support this work.