Microbicide Safety and Acceptability in Young Men

项目摘要 杀微生物剂是一种可以应用于阴道或直肠内壁的产品，以尝试降低 与无保护性交有关的艾滋病毒感染。阴道给药的安全性和有效性 杀微生物剂在有感染风险的妇女中进行了广泛的研究，但很少有研究关注 直肠使用杀微生物剂的安全性和可接受性。据认为，一旦阴道杀菌剂 一旦被开发出来，它将被用于阴道和直肠性交。因此，重要的是，我们要研究 这些产品在进行直肠性交的人中的安全性和可接受性。在美国， 感染艾滋病毒的弱势群体是年轻男子，特别是年轻的黑人和拉丁美洲男子。我们的研究 将在18-30岁的艾滋病毒阴性男性中进行种族多样化的样本， 不经常使用或根本不使用避孕套进行接受性直肠性交。我们的最终目标是测试 这一高度脆弱的人群是否可以安全地使用候选杀微生物剂VivaGel”，以及 安慰剂的使用模式与VivaGel不可区分”表明该产品将正确， 在真实的生活环境中一直使用。我们的研究将分两个阶段进行， 和坚持将首先研究使用安慰剂凝胶应用与专门设计的直肠交付 在现实生活中的性接触中或之前。随后，VivaGel”的安全性将在 对凝胶使用依从性最高的男性（定义为在e80%期间使用研究产品） episodes）。该安全性阶段将由单剂量的凝胶，随后一周的每日给药组成。 凝胶在这两个阶段的开始，我们将为所有参与者提供安全套使用咨询 根据个性化认知风险降低咨询方案， 在随机对照试验中显示出有效性。所有的参与者都将 通过临床、实验室和行为评估进行密切监测。定量和定性研究 将使用方法，以及自我报告、生物标志物和产品重新计数的组合。这项研究将 由宾夕法尼亚州匹兹堡的匹兹堡大学承担，和艾滋病临床和行为中心 研究（哥伦比亚大学和纽约州精神病研究所），纽约州纽约市。将有三个临床试验中心： 宾夕法尼亚州匹兹堡的匹兹堡大学;马萨诸塞州波士顿的芬威社区健康中心;以及 的波多黎各临床试验单位在圣胡安，PR。这项创新的研究将有助于发展一个 安全有效的杀微生物剂，预防艾滋病毒感染。

PROJECT SUMMARY ABSTRACT Microbicides are products that can be applied to the lining of the vagina or rectum to try and reduce the risk of HIV infection associated with unprotected sexual intercourse. The safety and effectiveness of vaginal microbicides have been studied widely in women at risk of infection but there are very few studies looking at the safety and acceptability of microbicides when used rectally. It is thought that once a vaginal microbicide is developed, it will be used for both vaginal and rectal intercourse. It is therefore important that we look at the safety and acceptability of these products in people who practice rectal sex. In the US, one of the most vulnerable groups for getting HIV infection are young men, especially young Black and Latino men. Our study will be conducted with an ethnically diverse sample of HIV-negative men, 18-30 year-olds, who report engaging in receptive rectal intercourse using condoms inconsistently or not at all. Our ultimate goal is to test whether this highly vulnerable population could safely use the microbicide candidate VivaGel" and whether patterns of use of a placebo indistinguishable from VivaGel" suggest that the product would be correctly and consistently used in real life circumstances. Our study will be conducted in two stages in which acceptability and adherence will be studied first using a placebo gel applied with a specifically designed rectal delivery device in, or prior to, real-life sexual encounters. Subsequently, the safety of VivaGel" will be studied among those men who show the highest adherence to gel use (defined as using the study product during e80% episodes). This safety phase will consist of a single dose of gel followed by one week of daily dosing with the gel. At the beginning of each of these two stages, we will provide all participants condom-use counseling following the Personalized Cognitive Risk-Reduction Counseling protocol, a risk-reduction counseling method to prevent HIV and STIs that showed efficacy in a randomly controlled trial. All of the participants will be closely monitored with clinical, laboratory, and behavioral assessments. Quantitative and qualitative research methods will be used, as well as combination of self-reports, biomarkers, and product recounts. The study will be undertaken by University of Pittsburgh in Pittsburgh, PA., and the HIV Center for Clinical and Behavioral Studies (Columbia University and NYS Psychiatric Institute) in NY, NY. There will be three clinical trial sites: the University of Pittsburgh in Pittsburgh, PA; the Fenway Community Health in Boston, MA; and the University of Puerto Rico Clinical Trial Unit in San Juan, PR. This innovative study will contribute to the development of a safe and effective microbicide for the prevention of HIV infection.