TOPICAL ESTROGEN TO THICKEN THE VAGINAL EPITHELIUM AND PREVENT INFECTIONS

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，不一定是研究者机构。本研究的目的是探索使用局部雌激素在妇女作为一种手段，以覆盖阴道上皮细胞和预防艾滋病毒感染的阴道性交。我们还旨在表明，局部应用雌激素可以逆转醋酸甲羟孕酮（DMPA）对阴道上皮可能产生的影响，从而使其能够继续作为避孕药广泛使用，即使研究表明，在没有雌激素的情况下使用，它往往会增加高流行社区感染艾滋病毒的风险。同时，我们希望表明，使用局部雌激素可以预防DMPA使用者和非使用者感染其他一些性传播感染。 为实现上述目标而提议的主要活动包括：1）对当前DMPA使用者进行的小型临床研究，以评估使用局部雌激素是否可以使阴道上皮增厚，2）更大的临床研究，以评估通过应用局部雌激素使阴道上皮增厚是否可以降低STI的发生率性活跃的异性恋女性中的（以及，如果可能的话，HIV）感染，3）评估女性及其伴侣对局部雌激素的可接受性的定性成分，4）（取决于上述组成部分的结果），协助注册该适应症的产品，并协助培训和推广使用外用雌激素作为DMPA的辅助药物，以预防STI（和HIV）DMPA使用者和可能不使用DMPA的妇女中的感染。计划会议在NIH主办的激素避孕和HIV传播会议上完成。已要求国际杀微生物剂伙伴关系申请开展这项研究的资金。

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. The goal of this research is to explore the use of topical estrogen in women as a means to thicken the vaginal epithelium and prevent HIV infection from vaginal intercourse. We also aim to show that application of topical estrogen can reverse the possible effects of depo medroxyprogesterone acepate (DMPA) on vaginal epithelium thereby making it possible to continue its widespread use as a contraceptive even if studies should show that, used without estrogen, it tends to increase the risk of HIV acquisition in high prevalence communities.. Simultaneously, we hope to show that the use of topical estrogen can prevent infection with a number of other sexually transmitted infections in both DMPA users and non-users. The major activities proposed to achieve the above objectives include: 1) a small clinical study on current DMPA users to evaluate whether use of a topical estrogen can thicken the vaginal epithelium, 2) a larger clinical study to evaluate whether thickening of the vaginal epithelium through application of topical estrogen can reduce the rate of STI (and, if possible HIV) infection among sexually active heterosexual women, 3) a qualitative component to assess acceptability of the topical estrogen among women and their partners, 4) (depending on the outcome of the above components), assisting with registration of the product for this indication and assisting with training and promotion of the use of topical estrogen as an adjunct to DMPA for prevention of STI (and HIV) infection among DMPA users and perhaps also women who do not use DMPA. Planning sessions were completed at a meeting Hormonal Contraception and HIV Transmission Sponsored by NIH. Applications for Funds to carry out the study have been requested from the International Partnership for Microbicides.