TOPICAL ESTROGEN TO THICKEN THE VAGINAL EPITHELIUM AND PREVENT INFECTIONS

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。本研究的目的是探索在女性中使用局部雌激素作为增厚阴道上皮和预防阴道性交中HIV感染的手段。我们还旨在表明，局部应用雌激素可以逆转羟孕酮醋酸酯（DMPA）对阴道上皮的可能影响，从而使其作为一种避孕药继续广泛使用成为可能，即使研究表明，在不使用雌激素的情况下，它往往会增加艾滋病毒感染的风险在高流行社区。同时，我们希望表明局部雌激素的使用可以预防DMPA使用者和非使用者感染许多其他性传播感染。为实现上述目标而建议的主要活动包括：1)一项针对当前DMPA使用者的小型临床研究，以评估使用局部雌激素是否能使阴道上皮增厚；2)一项更大规模的临床研究，以评估通过使用局部雌激素增厚阴道上皮是否能降低性活跃异性恋女性的性传播感染（如果可能的话，还有HIV）感染率；3)一个定性成分，以评估女性及其伴侣对局部雌激素的可接受性。4)（取决于上述组成部分的结果），协助该适应症的产品注册，并协助培训和推广使用局部雌激素作为DMPA的辅助药物，以预防DMPA使用者（可能也包括不使用DMPA的妇女）之间的性传播感染（和艾滋病毒）感染。计划会议在美国国立卫生研究院主办的荷尔蒙避孕和艾滋病毒传播会议上完成。国际杀微生物剂伙伴关系已要求为开展这项研究申请资金。

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.