Vaginal ring formulation of tenofovir microbicide

替诺福韦杀菌剂阴道环制剂

基本信息

批准号：
7417412
负责人：
Thomas J. Smith
金额：
$ 15.35万
依托单位：
OAK CREST INSTITUTE OF SCIENCE
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-01 至 2011-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7417412
关键词：
Acquired Immunodeficiency Syndrome Africa South of the Sahara Animal Model Animals Anti-Retroviral Agents Antiviral Agents Area Buffers Characteristics Cytomegalovirus Retinitis Development Drug Delivery Systems Drug Formulations Drug Kinetics Economic Development Employee Foundations Ganciclovir Gel Goals HIV HIV Infections Heterosexuals Highly Active Antiretroviral Therapy Implant Institutes Knowledge Lead Legal patent Marketing Modeling National Institute of Child Health and Human Development Persons Pharmaceutical Preparations Pharmacologic Substance Phase Phase I Clinical Trials Phase II Clinical Trials Process Production Recording of previous events Reporting Research Research Personnel Risk SIV Safety Sampling Science Services Silicones Solubility System Technology Tenofovir Testing United States National Institutes of Health Vaginal Ring Vaginal delivery procedure Water Woman World Health Organization base drug distribution efficacy testing empowered high risk implantation improved in vitro testing in vivo innovation interest microbicide non-nucleoside reverse transcriptase inhibitors novel programs public health relevance research and development research clinical testing sex transmission process volunteer

项目摘要

DESCRIPTION (provided by applicant): The broad long term goal of this project is to empower women to protect themselves from HIV infection through the development of improved microbicides based on sustained release drug delivery. Each day 15,000 people are infected - a growing majority of them women. The development of an effective microbicide is thus of high programmatic relevance to the NIH as well as other world health organizations. There are more than 60 candidate agents identified, 18 of which have proceeded to clinical testing. One area that is receiving intense interest is the vaginal delivery of antiretroviral agents. A Phase I trial (HPTN 050), sponsored by the NICHD and other institutes of the NIH, showed tolerability of a gel formulation of tenofovir. A Phase II trial (HPTN 059) will further assess safety and tolerability in a larger sample for longer periods. There is currently no sustained release formulation for tenofovir in development. A vaginal ring formulation of the NNRTI T-120 is being actively investigated and shows great promise. A significant drawback of the silicone based delivery platform is that only very low solubility drugs can be delivered. We have developed a platform technology for the sustained release of a broad range of drugs by implantation; antiviral levels have been maintained for long periods. This technology lead to the ganciclovir intraocular implant: the Vitrasert., approved for the treatment of AIDS related CMV retinitis. We propose to utilize this platform to develop sustained release vaginal ring formulations for tenofovir. This platform could also be utilized for other antiretroviral agents, thus increasing the feasibility of a microbicide equivalent of HAART. PUBLIC HEALTH RELEVANCE: Each day 15,000 people are infected by HIV, the majority in sub-Saharan Africa and a growing percentage women infected though heterosexual sex. The broad long term goal of this project is to empower women to protect themselves from HIV infection through the development of an improved microbicide based on the sustained release drug delivery of the antiretroviral agent tenofovir.

描述（由申请人提供）：该项目的广泛长期目标是通过基于持续释放药物的持续释放药物来开发改进的菌心来保护自己免受艾滋病毒感染的影响。每天有15,000人被感染 - 越来越多的女性。因此，有效的杀菌剂的发展与NIH以及其他世界卫生组织具有很高的程序化相关性。确定了60多个候选代理，其中18个已经进行了临床测试。引起强烈兴趣的一个区域是抗逆转录病毒药物的阴道递送。由NICHD和其他NIH机构赞助的I期试验（HPTN 050）显示了Tenofovir的凝胶配方的耐受性。 II期试验（HPTN 059）将进一步评估较大样本的安全性和耐受性。目前，Tenofovir在开发中尚无持续的释放配方。正在积极研究NNRTI T-120的阴道环制剂，并显示出巨大的希望。基于硅酮的递送平台的一个重要缺点是只能输送非常低的溶解度药物。我们已经开发了一种平台技术，可通过植入持续释放广泛的药物。长期保持抗病毒水平。这项技术导致了Ganciclovir的眼内植入物：Vitrasert。，批准用于治疗相关的CMV视网膜炎。我们建议利用该平台为Tenofovir开发持续的释放阴道配方。该平台也可以用于其他抗逆转录病毒药物，从而增加了与HAART相当的菌心的可行性。公共卫生相关性：每天有15,000人感染艾滋病毒，大多数在撒哈拉以南非洲以及越来越多的妇女受到异性恋性感染的妇女。该项目的长期长期目标是通过基于抗逆转录病毒剂Tenofovir的持续释放药物的递送来促进妇女保护自己免受艾滋病毒感染的能力。