课题基金 / 基金详情

LOPINAVIR/RITONAVIR PLUS EFAVIRENZ VERSUS LOPINAVIR/RITONAVIR PLUS STAVUDINE

LOPINAVIR/RITONAVIR PLUS EFAVIRENZ VERSUS LOPINAVIR/RITONAVIR PLUS STAVUDINE
洛匹那韦/利托那韦加依非韦伦对比洛匹那韦/利托那韦加司他夫定
批准号:
7606393
负责人:
MITCHELL J GOLDMAN
金额:
$3.34万
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-12-01 至 2007-11-30

项目摘要

项目成果

MITCHELL J GOLDMAN的其他基金

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中文摘要
翻译
这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者(PI)可能从另一个NIH来源获得了主要资金, 因此可以在其他CRISP条目中表示。所列机构为 研究中心,而研究中心不一定是研究者所在的机构。 A5142将评估三种不同抗HIV药物方案作为HIV感染一线治疗的安全性和有效性。 还将评估方案的效果。 给药方案为:洛匹那韦/利托那韦和依法韦仑、洛匹那韦/利托那韦、司他夫定(或齐多夫定)和拉米夫定。 如果药物治疗方案未能降低病毒载量或病毒对治疗产生耐药性,受试者将改用不同的治疗。 666例受试者将被随机分配至3个治疗组之一。 受试者将接受96 - 138周的随访,具体取决于他们入组的时间;研究访视将每四周进行一次,直至第32周,之后每八周进行一次。 评估将包括病史和用药史、有针对性的体格检查、拟人测量、实验室评估和双能X射线吸收扫描(DEXA)。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5142 will evaluate the safety and efficacy of three different anti-HIV drug regimens as first-line treatment for HIV infection. The effects of the regimens will also be assessed. The drug regimens are: lopinavir/ritonavir and efavirenz, lopinavir/ritonavir, stavudine (or zidovudine) and lamivudine. If a drug regimen fails to lower the viral load or if the virus becomes resistant to therapy, subjects will be switched to a different therapy. Six hundred sixty-six subjects will be randomized into one of the three treatment arms. Subjects will be followed for between 96 to 138 weeks, depending on when they enroll; study visits will be every four weeks up to week 32 and then every eight weeks thereafter. Assessments will include medical and medication histories, targeted physical exams, anthropomorphic measurements, laboratory evaluations, and a Dual energy x-ray absorptiometry scan (DEXA).
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会议论文
IMPACT OF THERAPEUTIC DRUG MONITORING ON VIROLOGIC RESPONSE TO A SALVAGE REGIMEN
ACUTE HIV INFECTION AND EARLY DISEASE RESEARCH PROGRAM (AIEDRP)
A MULTICENTER, OPEN-LABEL, CONTROLLED PHASE II STUDY TO EVALUATE SAFETY AND I
SEX DIFFERENCES IN LOPINAVIR/RITONAVIR PHARMACOKINETICS AMONG HIV-1-INFECTED