Abstract

This study will explore the usefulness of OCT imaging in assessing the in vivo cytotoxic effects of microbicides on cervicovaginal epithelium. Although OCT has been used in over 350 women to evaluate neoplastic processes, its value in assessing safety of new vaginal products has not been evaluated in humans. We have already demonstrated the potential usefulness of OCT imaging in animal models;this study will extend that to examine the use of OCT in humans. It is also likely to advance our knowledge of the impact of N-9 on the vaginal epithelium. OCT holds great promise for providing a sensitive, non-invasive assessment of tissue integrity that can be used in adjunct to colposcopy. Finally, the study will evaluate the women's motivation and barriers to participation in studies of this nature. Recent clinical trials of microbicides found that women were not adherent to use of the microbicide. Greater information about clinical trial participation may help in the future planning and implementation of microbicide trials .

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
3U19AI060598-05S1
Application #
7962682
Study Section
Special Emphasis Panel (ZRG1-AARR-A (51))
Project Start
2009-09-03
Project End
2010-08-31
Budget Start
2009-09-03
Budget End
2010-08-31
Support Year
5
Fiscal Year
2009
Total Cost
$344,091
Indirect Cost

  Institution

Name
Starpharma, Ltd
Department
Type
DUNS #
748902798
City
Melbourne
State
Country
Australia
Zip Code
VIC 3-004

  Publications

O'Hanlon, Deirdre E; Moench, Thomas R; Cone, Richard A (2013) Vaginal pH and microbicidal lactic acid when lactobacilli dominate the microbiota. PLoS One 8:e80074
Vincent, Kathleen Listiak; Vargas, Gracie; Bourne, Nigel et al. (2013) Image-based noninvasive evaluation of colorectal mucosal injury in sheep after topical application of microbicides. Sex Transm Dis 40:854-9
Vincent, Kathleen L; Vargas, Gracie; Wei, Jingna et al. (2013) Monitoring vaginal epithelial thickness changes noninvasively in sheep using optical coherence tomography. Am J Obstet Gynecol 208:282.e1-7
Aldunate, Muriel; Tyssen, David; Johnson, Adam et al. (2013) Vaginal concentrations of lactic acid potently inactivate HIV. J Antimicrob Chemother 68:2015-25
Radecki Breitkopf, Carmen; Loza, Melissa; Vincent, Kathleen et al. (2012) Acceptability of optical coherence tomography and abstinence requirements among women participating in microbicide safety trials. Sex Transm Dis 39:28-31
Breitkopf, Carmen Radecki; Loza, Melissa; Vincent, Kathleen et al. (2011) Perceptions of reimbursement for clinical trial participation. J Empir Res Hum Res Ethics 6:31-8
Vincent, Kathleen L; Stanberry, Lawrence R; Moench, Thomas R et al. (2011) Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial. Obstet Gynecol 118:1354-61
Telwatte, Sushama; Moore, Katie; Johnson, Adam et al. (2011) Virucidal activity of the dendrimer microbicide SPL7013 against HIV-1. Antiviral Res 90:195-9
O'Hanlon, Deirdre E; Moench, Thomas R; Cone, Richard A (2011) In vaginal fluid, bacteria associated with bacterial vaginosis can be suppressed with lactic acid but not hydrogen peroxide. BMC Infect Dis 11:200
Tyssen, David; Henderson, Scott A; Johnson, Adam et al. (2010) Structure activity relationship of dendrimer microbicides with dual action antiviral activity. PLoS One 5:e12309

Showing the most recent 10 out of 19 publications