Pharmacodynamic correlations using fresh and cryopreserved tissue following use of vaginal rings containing dapivirine and/or maraviroc in a randomized, placebo controlled trial.

作者: Charlene S. Dezzutti , Nicola Richardson-Harman , Lisa C. Rohan , Mark A. Marzinke , Craig J. Hoesley

DOI: 10.1097/MD.0000000000004174

关键词:

摘要: Background: The ex vivo challenge assay is a bio-indicator of drug efficacy and was utilized in this randomized, placebo controlled trial as one the exploratory endpoints. Fresh cryopreserved tissues were evaluated for human immunodeficiency virus (HIV) infection pharmacokinetic (PK)/pharmacodynamic (PD) relationships.

参考文章(47)
Samantha Abel, David J Back, Manoli Vourvahis, Maraviroc: pharmacokinetics and drug interactions. Antiviral Therapy. ,vol. 14, pp. 607- 618 ,(2009)
Beatrice A. Chen, Lori Panther, Mark A. Marzinke, Craig W. Hendrix, Craig J. Hoesley, Ariane van der Straten, Marla J. Husnik, Lydia Soto-Torres, Annalene Nel, Sherri Johnson, Nicola Richardson-Harman, Lorna K. Rabe, Charlene S. Dezzutti, Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial. Journal of Acquired Immune Deficiency Syndromes. ,vol. 70, pp. 242- 249 ,(2015) , 10.1097/QAI.0000000000000702
Kelly B. Collins, Bruce K. Patterson, Gregory J. Naus, Daniel V. Landers, Phalguni Gupta, Development of an in vitro organ culture model to study transmission of HIV-1 in the female genital tract. Nature Medicine. ,vol. 6, pp. 475- 479 ,(2000) , 10.1038/74743
Tian Zhou, Minlu Hu, Andrew Pearlman, Dorothy Patton, Lisa Rohan, Expression and localization of p-glycoprotein, multidrug resistance protein 4, and breast cancer resistance protein in the female lower genital tract of human and pigtailed macaque. AIDS Research and Human Retroviruses. ,vol. 30, pp. 1106- 1116 ,(2014) , 10.1089/AID.2013.0281
Fanfan Chen, Wenjie Zhang, Wei Wu, Yuqing Jin, Lian Cen, James D. Kretlow, Weicheng Gao, Zhenpeng Dai, Jiaming Wang, Guangdong Zhou, Wei Liu, Lei Cui, Yilin Cao, Cryopreservation of tissue-engineered epithelial sheets in trehalose. Biomaterials. ,vol. 32, pp. 8426- 8435 ,(2011) , 10.1016/J.BIOMATERIALS.2011.07.008
Brian Rinker, Xiangdong D. Cui, Dayong Y. Gao, Betsy F. Fink, Henry C. Vasconez, Michael L. Cibull, Cryopreservation of Composite Tissue Transplants Hand. ,vol. 3, pp. 17- 23 ,(2008) , 10.1007/S11552-007-9062-2
Lauren A Seserko, Joshua F Emory, Craig W Hendrix, Mark A Marzinke, The development and validation of an UHPLC–MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma Bioanalysis. ,vol. 5, pp. 2771- 2783 ,(2013) , 10.4155/BIO.13.256
Phalguni Gupta, Deena Ratner, Bruce K. Patterson, Kathy Kulka, Lisa C. Rohan, Michael A. Parniak, Charles E. Isaacs, Sharon Hillier, Use of frozen-thawed cervical tissues in the organ culture system to measure anti-HIV activities of candidate microbicides. AIDS Research and Human Retroviruses. ,vol. 22, pp. 419- 424 ,(2006) , 10.1089/AID.2006.22.419
Ian McGowan, Karen Tanner, Julie Elliott, Javier Ibarrondo, Elena Khanukhova, Charina McDonald, Terry Saunders, Ying Zhou, Peter A. Anton, Nonreproducibility of "snap-frozen" rectal biopsies for later use in ex vivo explant infectibility studies. AIDS Research and Human Retroviruses. ,vol. 28, pp. 1509- 1512 ,(2012) , 10.1089/AID.2012.0062
Lut Van Damme, Roshini Govinden, Florence M Mirembe, Fernand Guédou, Suniti Solomon, Marissa L Becker, BS Pradeep, AK Krishnan, Michel Alary, Bina Pande, Gita Ramjee, Jennifer Deese, Tania Crucitti, Doug Taylor, None, Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. The New England Journal of Medicine. ,vol. 359, pp. 463- 472 ,(2008) , 10.1056/NEJMOA0707957