CAMPO Clinical Trials Program

加州-墨西哥-波多黎各(坎波)联盟将进行三项临床研究 重点关注在墨西哥和波多黎各艾滋病毒阳性妇女中预防宫颈癌。研究1 将在4000年中检查宫颈高度鳞状上皮内病变(HSIL)的新筛查算法 墨西哥和波多黎各的艾滋病毒阳性妇女。研究2将评估使用肛门益生菌对 600名HIV阳性男女的肛门和宫颈微生物区系特征及其与肛门和宫颈HSIL消退的关系，以及在没有病变的人群中高危HPV DNA持久性的降低。 研究3将评估以多价复制缺陷型腺病毒为基础的安全性和有效性 治疗性HPV疫苗治疗300例HIV阳性男女宫颈和肛门HSIL 免疫应答与HSIL回归相关。坎波临床试验计划有以下目标： (1)在墨西哥和波多黎各的艾滋病毒阳性妇女中确定最佳的宫颈筛查策略 HSIL检测，包括细胞学、HPV扩增分型、癌蛋白E6/E7检测和甲基化标志物； (2)观察VISBIOME™益生菌对宫颈和肛门HSIL消退的安全性和有效性。 减少墨西哥和波多黎各艾滋病毒阳性妇女和男子中高危HPV感染的持久性；以及 (3)检测新型治疗性疫苗治疗宫颈和肛门HSIL消退的安全性和有效性。 墨西哥和波多黎各的艾滋病毒阳性妇女和男子。临床试验计划将由乔尔博士领导 Palefsky(联系MPI)和由Insp的Jorge Salmerón博士(MPI)共同领导。三国的礼宾主席 研究人员是Jorge Salmerón博士(研究1)、UPR Josefina Romaguera博士(研究2)和George Sawaya博士 加州大学旧金山分校(研究3)。每项研究的礼宾小组将由礼宾主席、以下人员代表组成 每个坎波核心，一名来自Emmes的代表，以及来自所有三个地点的具有相关专业知识的调查人员 和利息。每一项研究都具有很高的创新性。研究1使用新的招聘方法和 对艾滋病毒阳性妇女进行宫颈筛查，并将包括成本效益和生活质量 分析。研究2将测试一种用于治疗HIV阳性男女HSIL的益生菌的安全性，以及 它有能力降低那些没有患病的人中持续感染HrHPV的风险。研究3将测试一部小说 用于治疗HSIL的治疗性疫苗，涵盖多种hrHPV类型和HPV蛋白。我们期待着 这三项研究的结果改变了HSIL的筛查和治疗范式，具有潜力 大幅降低墨西哥艾滋病毒阳性妇女和男子的宫颈癌和肛门癌发病率 还有波多黎各。我们的结果将广泛适用于拉丁美洲和加勒比地区的其他人口 在很大程度上，对拉美裔和美国其他女性来说也是如此。

The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIVpositive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. The CAMPO Clinical Trials Program has the following aims: (1) To identify optimal screening strategies among HIV-positive women in Mexico and Puerto Rico for cervical HSIL detection, including cytology, HPV extended-typing, oncoprotein E6/E7 testing and methylation markers; (2) To determine the safety and efficacy of Visbiome™ probiotic on cervical and anal HSIL regression and reduced persistence of high-risk HPV infection in HIV-positive women and men in Mexico and Puerto Rico; and (3) To determine the safety and efficacy of a novel therapeutic vaccine on cervical and anal HSIL regression in HIV-positive women and men in Mexico and Puerto Rico. The Clinical Trials Program will be led by Dr. Joel Palefsky (Contact MPI) and co-led by Dr. Jorge Salmerón (MPI) of the INSP. The Protocol Chairs of the three studies are Dr. Jorge Salmerón (Study 1), Dr. Josefina Romaguera of UPR (Study 2), and Dr. George Sawaya of UCSF (Study 3). Protocol Teams for each study will be comprised of the Protocol Chair, representatives of each CAMPO Core, a representative from Emmes, and investigators from all three sites with relevant expertise and interest. Each of the studies is highly innovative. Study 1 uses new approaches for recruitment and performance of cervical screening in HIV-positive women and will include cost-effectiveness and quality of life analyses. Study 2 will test the safety of a probiotic for treatment of HSIL in HIV-positive women and men and its ability to reduce the risk of persistent hrHPV infection among those without disease. Study 3 will test a novel therapeutic vaccine for treatment of HSIL that covers multiple hrHPV types and HPV proteins. We expect the results of the three studies to change the paradigm of both screening and treatment of HSIL, with the potential to substantially reduce the incidence of cervical and anal cancers in HIV-positive women and men in Mexico and Puerto Rico. Our results will be broadly applicable to other populations in the Latin America and Caribbean region, and to a large extent, to Hispanic and other women in the U.S.