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:
- 金额:$ 15.35万
- 依托单位:
- 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:
- 关键词:Acquired Immunodeficiency SyndromeAfrica South of the SaharaAnimal ModelAnimalsAnti-Retroviral AgentsAntiviral AgentsAreaBuffersCharacteristicsCytomegalovirus RetinitisDevelopmentDrug Delivery SystemsDrug FormulationsDrug KineticsEconomic DevelopmentEmployeeFoundationsGanciclovirGelGoalsHIVHIV InfectionsHeterosexualsHighly Active Antiretroviral TherapyImplantInstitutesKnowledgeLeadLegal patentMarketingModelingNational Institute of Child Health and Human DevelopmentPersonsPharmaceutical PreparationsPharmacologic SubstancePhasePhase I Clinical TrialsPhase II Clinical TrialsProcessProductionRecording of previous eventsReportingResearchResearch PersonnelRiskSIVSafetySamplingScienceServicesSiliconesSolubilitySystemTechnologyTenofovirTestingUnited States National Institutes of HealthVaginal RingVaginal delivery procedureWaterWomanWorld Health Organizationbasedrug distributionefficacy testingempoweredhigh riskimplantationimprovedin vitro testingin vivoinnovationinterestmicrobicidenon-nucleoside reverse transcriptase inhibitorsnovelprogramspublic health relevanceresearch and developmentresearch clinical testingsextransmission processvolunteer
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):该项目广泛的长期目标是通过开发基于缓释药物传递的改进的杀微生物剂来增强妇女保护自己免受艾滋病毒感染的能力。每天有15,000人感染--其中越来越多的是女性。因此,开发一种有效的杀微生物剂对美国国立卫生研究院和其他世界卫生组织具有很高的方案相关性。已确定的候选药物有60多种,其中18种已进入临床试验。引起人们强烈兴趣的一个领域是抗逆转录病毒药物的阴道给药。由NICHD和美国国立卫生研究院其他研究所赞助的一项I期试验(HPTN 050)显示,替诺福韦凝胶制剂是耐受性的。第二阶段试验(HPTN 059)将在更长时间内的更大样本中进一步评估安全性和耐受性。目前尚无正在开发中的替诺福韦缓释制剂。NNRTI T-120的一种阴道环配方正在积极研究中,并显示出巨大的前景。基于硅胶的给药平台的一个显著缺点是只能给药非常低的溶解度。我们已经开发了一种平台技术,可以通过植入来持续释放多种药物;抗病毒水平已经保持了很长时间。这项技术导致了更昔洛韦眼内植入物:Vitrasert,被批准用于治疗艾滋病相关的CMV视网膜炎。我们建议利用这一平台来开发替诺福韦的缓释阴道环制剂。该平台还可以用于其他抗逆转录病毒药物,从而增加了等同于HAART的杀微生物剂的可行性。
与公共卫生相关:每天有15,000人感染艾滋病毒,其中大多数在撒哈拉以南非洲,通过异性性行为感染的妇女比例越来越高。该项目广泛的长期目标是通过开发一种基于抗逆转录病毒药物替诺福韦缓释药物的改良杀微生物剂,使妇女能够保护自己免受艾滋病毒感染。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Thomas J. Smith其他文献
Size-selective pulmonary dose indices for metal-working fluid aerosols in machining and grinding operations in the automobile manufacturing industry.
汽车制造业机械加工和磨削操作中金属加工液气溶胶的尺寸选择性肺部剂量指数。
- DOI:
- 发表时间:
1994 - 期刊:
- 影响因子:0
- 作者:
Susan Woskie;Thomas J. Smith;M. Hallock;S. Hammond;Frank Rosenthal;Ellen A. Eisen;David Kriebel;Ian A. Greaves - 通讯作者:
Ian A. Greaves
Symptom Management in Home-Based Palliative Care
家庭姑息治疗中的症状管理
- DOI:
- 发表时间:
2018 - 期刊:
- 影响因子:0
- 作者:
S. Isenberg;R. Razzak;M. Rabow;Thomas J. Smith - 通讯作者:
Thomas J. Smith
Financial Aspects of Outpatient Palliative Care
门诊姑息治疗的财务问题
- DOI:
- 发表时间:
2019 - 期刊:
- 影响因子:0
- 作者:
S. Isenberg;R. Razzak;M. Rabow;Thomas J. Smith - 通讯作者:
Thomas J. Smith
Strange Baryon Production in Hadronic Z 0 Decays OPAL Collaboration
Hadronic Z 0 中奇异重子的产生削弱了 OPAL 合作
- DOI:
- 发表时间:
2019 - 期刊:
- 影响因子:0
- 作者:
G. Alexander;J. Allison;N. Altekamp;K. Ametewee;K. Anderson;S. Anderson;S. Arcelli;S. Asai;D. Axen;G. Azuelos;A. Ball;E. Barberio;R. Barlow;R. Bartoldus;J. Batley;J. Bechtluft;C. Beeston;T. Behnke;A. Bell;K. Bell;G. Bella;S. Bentvelsen;P. Berlich;S. Bethke;O. Biebel;V. Blobel;I. Bloodworth;J. Bloomer;M. Bobinski;P. Bock;H. M. Bosch;M. Boutemeur;B. Bouwens;S. Braibant;Robert M. Brown;H. Burckhart;C. Burgard;R. Bürgin;P. Capiluppi;R. Carnegie;A. Carter;J. Carter;C. Y. Chang;C. Charlesworth;D. Charlton;D. Chrisman;S. Chu;P. Clarke;I. Cohen;J. Conboy;O. Cooke;M. Cuffiani;S. Dado;C. Dallapiccola;G. Dallavalle;S. Jong;L. Pozo;K. Desch;M. Dixit;E. Silva;M. Doucet;E. Duchovni;G. Duckeck;I. Duerdoth;J. Edwards;P. Estabrooks;H. Evans;M. Evans;F. Fabbri;P. Fath;F. Fiedler;M. Fierro;H. Fischer;R. Folman;D. Fong;M. Foucher;A. Fürtjes;P. Gagnon;A. Gaidot;J. Gary;J. Gascón;S. Gascon;N. Geddes;C. Geich;F. Gentit;T. Geralis;G. Giacomelli;Paolo Giacomelli;R. Giacomelli;V. Gibson;W. Gibson;D. Gingrich;D. Glenzinski;J. Goldberg;M. Goodrick;W. Gorn;C. Grandi;E. Gross;M. Gruwe;C. Hajdu;G. Hanson;M. Hansroul;M. Hapke;C. Hargrove;P. Hart;C. Hartmann;M. Hauschild;C. Hawkes;R. Hawkings;R. J. Hemingway;G. Herten;R. Heuer;M. Hildreth;J. Hill;S. Hillier;T. Hilse;P. Hobson;R. Homer;A. Honma;D. Horvath;R. Howard;R. Hughes;D. Hutchcroft;P. Igo;D. Imrie;M. Ingram;K. Ishii;A. Jawahery;P. Jeffreys;H. Jérémie;M. Jimack;A. Joly;C. Jones;G. Jones;M. Jones;R. Jones;U. Jost;P. Jovanović;T. Junk;D. Karlen;K. Kawagoe;T. Kawamoto;R. Keeler;R. Kellogg;B. Kennedy;B. King;J. Kirk;S. Kluth;T. Kobayashi;M. Kobel;D. Koetke;T. Kokott;S. Komamiya;R. Kowalewski;T. Kress;P. Krieger;J. Krogh;P. Kyberd;G. Lafferty;H. Lafoux;R. Lahmann;W. Lai;D. Lanske;J. Lauber;S. Lautenschlager;J. Layter;D. Lazic;A. Lee;E. Lefebvre;D. Lellouch;J. Letts;L. Levinson;C. Lewis;S. Lloyd;F. Loebinger;G. D. Long;M. Losty;J. Ludwig;A. Luig;A. Malik;M. Mannelli;S. Marcellini;C. Markus;A. Martin;J. Martin;G. Martinez;T. Mashimo;W. Matthews;P. Mättig;W. Mcdonald;J. Mckenna;E. Mckigney;T. Mcmahon;A. McNab;R. McPherson;F. Meijers;S. Menke;F. Merritt;H. Mes;Jean;A. Michelini;G. Mikenberg;D. Miller;R. Mir;W. Mohr;A. Montanari;Takashi Mori;M. Morii;U. C. Muller;K. Nagai;I. Nakamura;H. Neal;B. Nellen;B. Nijjhar;R. Nisius;S. O'neale;F. G. Oakham;F. Odorici;H. Ogren;T. Omori;M. Oreglia;S. Orito;J. Pálinkás;G. Pásztor;J. Pater;G. Patrick;J. Patt;M. J. Pearce;S. Petzold;P. Pfeifenschneider;J. Pilcher;J. Pinfold;D. Plane;P. Poffenberger;B. Poli;A. Posthaus;H. Przysiezniak;D. Rees;D. Rigby;S. Robins;N. Rodning;J. Roney;A. Rooke;E. Ros;A. Rossi;M. Rosvick;P. Routenburg;Y. Rozen;K. Runge;O. Rúnolfsson;U. Ruppel;D. Rust;R. Ryłko;K. Sachs;E. Sarkisyan;M. Sasaki;C. Sbarra;A. Schaile;O. Schaile;F. Scharf;P. Scharff;P. Schenk;B. Schmitt;S. Schmitt;M. Schröder;H. Schultz;M. Schulz;M. Schumacher;P. Schütz;W. Scott;T. Shears;B. Shen;C. Shepherd;P. Sherwood;G. Siroli;A. Sittler;A. Skillman;A. Skuja;A. Smith;Thomas J. Smith;G. Snow;R. Sobie;S. Söldner;R. Springer;M. Sproston;A. Stahl;M. Starks;M. Steiert;K. Stephens;J. Steuerer;B. Stockhausen;D. Strom;F. Strumia;P. Szymański;R. Tafirout;S. Talbot;S. Tanaka;P. Taras;S. Tarem;M. Tecchio;M. Thiergen;M. Thomson;E. Törne;S. Towers;T. Tsukamoto;E. Tsur;A. Turcot;M. F. Turner;P. Utzat;R. Kooten;G. Vasseur;M. Verzocchi;P. Vikas;M. Vincter;E. Vokurka;F. Wäckerle;A. Wagner;C. Ward;D. Ward;J. Ward;P. Watkins;A. Watson;N. Watson;P. Weber;P. Wells;N. Wermes;J. S. White;B. Wilkens;G. Wilson;J. Wilson;G. Wolf;S. Wotton;T. Wyatt;S. Yamashita;G. Yekutieli;V. Zacek - 通讯作者:
V. Zacek
Failure to accrue to a study of nebulized fentanyl for dyspnea: lessons learned.
芬太尼雾化治疗呼吸困难的研究失败:经验教训。
- DOI:
- 发表时间:
2009 - 期刊:
- 影响因子:2.8
- 作者:
Thomas J. Smith;P. Coyne;W. French;V. Ramakrishnan;Patricia A Corrigan - 通讯作者:
Patricia A Corrigan
Thomas J. Smith的其他文献
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{{ truncateString('Thomas J. Smith', 18)}}的其他基金
Longer-acting intravaginal formulation of buprenorphine
长效丁丙诺啡阴道内制剂
- 批准号:
10454496 - 财政年份:2020
- 资助金额:
$ 15.35万 - 项目类别:
Longer-acting intravaginal formulation of buprenorphine
长效丁丙诺啡阴道内制剂
- 批准号:
10472754 - 财政年份:2020
- 资助金额:
$ 15.35万 - 项目类别:
Longer-acting intravaginal formulation of buprenorphine
长效丁丙诺啡阴道内制剂
- 批准号:
10158129 - 财政年份:2020
- 资助金额:
$ 15.35万 - 项目类别:
I-Corps: Longer-acting intravaginal formulation of buprenorphine
I-Corps:长效丁丙诺啡阴道内制剂
- 批准号:
10337527 - 财政年份:2020
- 资助金额:
$ 15.35万 - 项目类别:
IND-enabling preclinical development of a sustained-release Pritelivir intravaginal ring for the treatment and prophylaxis of Genital Herpes in women
缓释 Pritelivir 阴道环用于治疗和预防女性生殖器疱疹的 IND 临床前开发
- 批准号:
9906167 - 财政年份:2018
- 资助金额:
$ 15.35万 - 项目类别:
IND-enabling preclinical development of a multipurpose intravaginal ring for the prevention of Herpes, HIV and unintended pregnancy
用于预防疱疹、艾滋病毒和意外怀孕的多用途阴道环的临床前开发,可用于 IND 临床前开发
- 批准号:
10378141 - 财政年份:2018
- 资助金额:
$ 15.35万 - 项目类别:
IND-enabling preclinical development of a system for the multipurpose prevention of HIV and unintended pregnancy
支持 IND 的临床前开发系统,用于多用途预防艾滋病毒和意外怀孕
- 批准号:
9981612 - 财政年份:2016
- 资助金额:
$ 15.35万 - 项目类别:
Clinical safety and pharmacokinetic studies of intravaginal rings releasing multiple antiretrovirals
阴道环释放多种抗逆转录病毒药物的临床安全性和药代动力学研究
- 批准号:
9047287 - 财政年份:2013
- 资助金额:
$ 15.35万 - 项目类别:
Vaginal ring formulation of tenofovir microbicide
替诺福韦杀菌剂阴道环制剂
- 批准号:
7924103 - 财政年份:2009
- 资助金额:
$ 15.35万 - 项目类别:
Automation of GMP manufacturing of HIV microbicide rings
HIV 杀菌剂环 GMP 生产自动化
- 批准号:
8993538 - 财政年份:2009
- 资助金额:
$ 15.35万 - 项目类别:
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