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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。HIV感染是HPV感染和HPV相关疾病发展的重要危险因素。今天，HART治疗已被证明可以显著增加cd4细胞计数和部分重建免疫系统。A5029是一项观察性、多中心、前瞻性研究，旨在评估48周后对HAART有反应且HIV-1 RNA水平被抑制的hiv感染者中HPV DNA的转化率。研究人群包括未接受抗逆转录病毒治疗、感染艾滋病毒、月经初潮后的女性。子宫颈抹片检查和其他研究数据将在基线、第24周、第48周以及之后每48周从受试者中前瞻性地获得。本研究将在最后一名受试者累计后持续144周。共有160名受试者被纳入研究，他们是艾滋病毒感染、未接受抗逆转录病毒治疗、初潮后、年龄在10至13岁之间的女性，自艾滋病毒诊断以来任何时间接受了14天的抗逆转录病毒治疗。受试者必须共同入选已批准的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，也将继续使用A5029。

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.