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PREVALENCE OF HPV DNA IN HIV INFECTED WOMEN WHO HAVE INITIATED HAART (A5029)

PREVALENCE OF HPV DNA IN HIV INFECTED WOMEN WHO HAVE INITIATED HAART (A5029)
已开始 HAART 的 HIV 感染女性中 HPV DNA 的患病率 (A5029)
批准号:
7379061
负责人:
Kenneth H. Fife
金额:
$0.22万
依托单位国家:
美国
项目类别:
财政年份:
2005
资助国家:
美国
项目状态:
已结题
起止时间:
2005-12-01 至 2006-11-30

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中文摘要
翻译
该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心机构,不一定为研究者机构。HIV感染是HPV感染和HPV相关疾病发展的重要危险因素。如今,已经证明用哈特治疗可导致CD 4细胞计数的显著增加和免疫系统的部分重建。A5029是一项观察性、多中心、前瞻性研究,旨在评估HAART治疗48周后HIV-1 RNA水平受到抑制的HIV感染受试者的HPV DNA转化率。研究人群包括未接受过抗逆转录病毒治疗、HIV感染、月经初潮后的女性。将在基线、第24、48周和此后每48周从受试者中前瞻性获得巴氏涂片和其他研究数据。研究将在最后一例受试者入组后延长144周。将入组总共160名受试者,这些受试者是HIV感染的、抗逆转录病毒初治的、月经初潮后女性,年龄>13岁,自HIV诊断以来的任何时间都接受了14天的抗逆转录病毒治疗。受试者必须共同入组已批准的HAART治疗试验(II期或更高阶段),并且只要开始抗逆转录病毒试验HAART治疗,即使他们退出抗逆转录病毒试验,也将继续接受A5029治疗。
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. HIV infection is a significant risk factor for HPV infection and the development of HPV-associated diseases. Today, treatment with HART has been demonstrated to result in significant increase in CD 4 cell counts and partial reconstitution of the immune system. A5029 is an observational, multicenter, prospective study designed to assess the conversion rate of HPV DNA among those HIV-infected subjects who have responded to HAART with suppressed HIV-1 RNA levels after 48 weeks. The study population includes antiretroviral-naive, HIV-infected, post-menarche females. Pap smears and other study data will be obtained prospectively from subjects at baseline, weeks 24,48 and every 48 weeks thereafter. The study will extend for 144 weeks after accrual of the last subject. A total of 160 subjects who are HIV-infected, antiretroviral naive, post-menarche females >13 years of age with 14 days of antiretroviral therapy at any time since HIV diagnosis will be enrolled. Subjects must be coenrolled in an approved Haart treatment trial, Phase II or higher, and will remain on A5029 even if they withdraw from the antiretroviral trial, as long as the antiretroviral trial HAART treatment was begun.
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