ADULT AIDS CLINICAL TRIALS UNIT (ACTU)
ADULT AIDS CLINICAL TRIALS UNIT (ACTU)
批准号:
6626479
负责人:
Kathleen E. Squires
金额:
$163.98万
依托单位国家:
美国
项目类别:
财政年份:
1992
资助国家:
美国
项目状态:
已结题
起止时间:
1992-03-01 至 2004-12-31
关键词:
AIDS AIDS /HIV neuropathy AIDS related neoplasm /cancer AIDS therapy HIV infections Histoplasma Mycobacterium avium Mycobacterium tuberculosis Pneumocystis pneumonia antiAIDS agent antiviral antibody body composition cardiovascular disorder cardiovascular disorder prevention clinical research clinical trial phase I cooperative study cytomegalovirus drug adverse effect drug interactions experimental designs gender difference glucose metabolism hepatitis B virus group hepatitis C virus human immunodeficiency virus 1 human subject human therapy evaluation hydroxyurea immunoregulation immunotherapy latent virus infection lipid metabolism longitudinal human study nucleoside analog nucleotide analog nutrition opportunistic infections outcomes research pathologic process pharmacokinetics prodrugs protease inhibitor statistics /biometry therapy compliance
中文摘要
描述(改编自申请摘要):艾滋病临床试验
南加州大学(USC)的ACTU是
1986年开始资助ACTG单位。 自成立以来,USC ACTU已
在这方面,有相当多的妇女和少数族裔病人。 作为
例如,在1998年,19%的研究患者是女性,81%的患者是女性。
是少数民族(61%的西班牙裔,15%的非西班牙裔黑人,4%的非西班牙裔黑人)。
1%的亚洲人,1%的美洲印第安人)。 领域的研究
机会性感染(OIs)一直很活跃。 在前两次融资中
该股领导ACTG设计和执行研究,
治疗和预防OIs。 此外,南加州大学OI研究的应计费用
占ACTG组OI研究总工作量的38%。 期间
在同一年,南加州大学也积极研究HA的治疗方法
感染 随着OIs患病率的下降,USC部门最近
集中精力研究艾滋病毒感染,代谢和神经系统
并发症、免疫重建以及与感染艾滋病毒的妇女有关的问题。
在上一个资助期内,南加州大学的调查人员担任了AACTG职位,
(委员会和礼宾主席),并提供领导,
研究代谢失调综合征(腹部)
肥胖、胰岛素抵抗、脂质失调和脂肪营养不良),
发生在许多接受HAART治疗的患者中。 这些异常可以预测
艾滋病病毒感染者的发病率和死亡率将因
加速动脉粥样硬化形成导致的心血管并发症,
对艾滋病毒感染者来说是严重的并发症。 拟将
该股的调查员将领导制定
ACTG的科学议程,涉及未来几年出现的问题,
融资周期。 南加州大学的该单位也有病人滞留的记录,
数据管理(终点确定、源文件和查询)
连续两年以上,每月得分100分。 最后,
南加州大学继续增加受试者(每年100人)到小学
问题研究 因此,申请人提出USC具有基础设施,
开展研究,涵盖《科学和技术法》中概述的许多科学目的和目标,
集团应用,提供科学的领导,在一些重要的
区域,以确保及时传输高质量数据,以及
从而成为艾滋病治疗小组的一个组成部分。
英文摘要
DESCRIPTION (adapted from application's abstract): The AIDS Clinical Trials
Unit (ACTU) at the University of Southern California (USC) was one of the
original ACTG units funded in 1986. Since its inception, the USC ACTU has
accrued a substantial number of women and patients from ethnic minorities. As
an example, in 1998, 19 percent of study patients were women and 81 percent
were minorities (61 percent Hispanic, 15 percent non-Hispanic blacks, 4
percent Asian, 1 percent American Indian). Research in the area of
opportunistic infections (OIs) has been active. During the first two funding
cycles, this Unit led the ACTG in the design and execution of studies for the
treatment and prevention of OIs. Moreover, accrual for OI studies at USC
represented 38 percent of the total ACTG group effort for OI studies. During
these same years, the USC Unit also was active in studies of therapies for HA
infection. With the decreasing prevalence of OIs, the USC Unit recently has
focused efforts to studies of HIV infection, metabolic and neurologic
complications, immune reconstitution, and issues relating to women with HIV.
In the last funding period, investigators from USC have held AACTG positions
(committee and protocol chairs) and have provided leadership to develop
studies to investigate the metabolic dysregulation syndromes (abdominal
obesity, insulin resistance, lipid dysregulation, and lipodystrophy) that
occur in many patients treated with HAART. These abnormalities can predict
that patients with HIV will experience excess morbidity and mortality from
cardiovascular complications resulting from accelerated atherogenesis and may
be serious complications for persons with HIV. It is proposed that
investigators from this Unit will provide leadership in developing the
scientific agenda of the ACTG that involves emerging problems during the next
funding cycle. The Unit at USC also has had a record of patient retention and
data management (endpoint determinations, source documentation, and queries)
with consistent monthly scores of 100 points for more than 2 years. Finally,
USC continues to accrue subjects (in the range of 100 per year) to primary
studies. Thus, the applicants propose that USC has the infrastructure to
conduct studies that cover many scientific aims and objectives outlined in the
Group Application, to provide scientific leadership in a number of important
areas, to assure that quality data is transmitted in a timely manner, and
thereby to serve as an integral component of the HIV treatment group.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
DRUG LEVELS OF LOPINAVIR/RITONAVIR IN MEN AND WOMEN
-
批准号:7716699
-
项目类别:
-
资助金额:$0.06万
-
财政年份:2008
-
负责人:Kathleen E. Squires
-
依托单位:
A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LIPONAVIR/RITONAVIR PLUS
-
批准号:7716683
-
项目类别:
-
资助金额:$0.83万
-
财政年份:2008
-
负责人:Kathleen E. Squires
-
依托单位:
Quintiles Clinical Trial Unit for HIV/AIDS Clinical Trials Networks
-
批准号:7355581
-
项目类别:
-
资助金额:$94.68万
-
财政年份:2007
-
负责人:Kathleen E. Squires
-
依托单位:
Quintiles Clinical Trial Unit for HIV/AIDS Clinical Trials Networks
-
批准号:7577386
-
项目类别:
-
资助金额:$88.66万
-
财政年份:2007
-
负责人:Kathleen E. Squires
-
依托单位:
A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LIPONAVIR/RITONAVIR PLUS
-
批准号:7603907
-
项目类别:
-
资助金额:$5.16万
-
财政年份:2006
-
负责人:Kathleen E. Squires
-
依托单位:
DRUG LEVELS OF LOPINAVIR/RITONAVIR IN MEN AND WOMEN
-
批准号:7603923
-
项目类别:
-
资助金额:$0.34万
-
财政年份:2006
-
负责人:Kathleen E. Squires
-
依托单位:
DRUG LEVELS OF LOPINAVIR/RITONAVIR IN MEN AND WOMEN
-
批准号:7368229
-
项目类别:
-
资助金额:$0.61万
-
财政年份:2005
-
负责人:Kathleen E. Squires
-
依托单位:
ACTG A5039: AN OPEN-LABEL, NON-RANDOMIZED STUDY OF PHARMACOKINETIC INTERACTIONS
-
批准号:7199996
-
项目类别:
-
资助金额:$2.15万
-
财政年份:2004
-
负责人:Kathleen E. Squires
-
依托单位:
A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LIPONAVIR/RITONAVIR PLUS
-
批准号:7200010
-
项目类别:
-
资助金额:$10.54万
-
财政年份:2004
-
负责人:Kathleen E. Squires
-
依托单位:
A PHASE II STUDY OF THE PREDICTIVE VALUE OF PHARMACOKINETIC-ADJUSTED PHENOTYPIC
-
批准号:7200004
-
项目类别:
-
资助金额:$1.72万
-
财政年份:2004
-
负责人:Kathleen E. Squires
-
依托单位:
A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY,
-
批准号:7200003
-
项目类别:
-
资助金额:$0.21万
-
财政年份:2004
-
负责人:Kathleen E. Squires
-
依托单位:
A PHASE II STUDY OF PREDICTIVE VALUE OF PHARMACOKINETICS
-
批准号:7040174
-
项目类别:
-
资助金额:$1.08万
-
财政年份:2003
-
负责人:Kathleen E. Squires
-
依托单位:
A RANDOMIZED, COMPARATIVE STUDY OF LIPONAVIR/RITONAVIR
-
批准号:7040175
-
项目类别:
-
资助金额:$1.08万
-
财政年份:2003
-
负责人:Kathleen E. Squires
-
依托单位:
A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON
-
批准号:7040181
-
项目类别:
-
资助金额:$3.44万
-
财政年份:2003
-
负责人:Kathleen E. Squires
-
依托单位:
ACTG A5039: AN OPEN-LABEL, NON-RANDOMIZED STUDY
-
批准号:7040164
-
项目类别:
-
资助金额:$1.93万
-
财政年份:2003
-
负责人:Kathleen E. Squires
-
依托单位:
ADULT AIDS CLINICAL TRIALS UNIT (ACTU)
-
批准号:6488916
-
项目类别:
-
资助金额:$154.29万
-
财政年份:1992
-
负责人:Kathleen E. Squires
-
依托单位: