The objective of this application is to define the leadership and operational structures for the Microbicide Trials Network (MTN). The MTN was first established in 2006 to identify a safe and effective microbicide for HIV prevention. From the outset, the MTN targeted key populations at risk of HIV including women in Sub- Saharan Africa, adolescents, pregnant and lactating women, and MSM. Over the last six years, the MTN has developed an expansive program in vaginal and rectal microbicide development, with unique and substantial contributions to the field in the understanding of the safety, effectiveness, pharmacokinetics, and the behavioral context associated with the use of topical microbicides. Since its inception, it has developed a total of 31 new protocols. The proposed plan in this continuing application is to build on this foundation of research to expand the portfolio of active agents to be tested in phase 1-3 studies over the next 7 years. It is anticipated that these studies will build toward a phase 2B/3 studies of a rectal microbicide and a combination antiretroviral/hormonal contraceptive ring. Cutting edge biomedical and behavioral research approaches will be incorporated through the contributions of the biomedical and behavioral research working groups, and community perspectives on protocols will be incorporated through the community working group.

Public Health Relevance

Microbicides are new drug products which are being developed for use by people for prevention of HIV infection. This grant application describes a leadership structure for the Microbicide Trials Network, a clinical trials network whose purpose is to develop microbicide products from the early stages of product development through final approval by regulatory authorities.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-RRS-A (S1))
Program Officer
Black, Roberta J
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Magee-Women's Research Institute and Foundation
United States
Zip Code
van der Straten, Ariane; Mayo, Ashley; Brown, Elizabeth R et al. (2015) Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial. AIDS Behav 19:770-83
Richardson-Harman, Nicola; Hendrix, Craig W; Bumpus, Namandjé N et al. (2014) Correlation between compartmental tenofovir concentrations and an ex vivo rectal biopsy model of tissue infectibility in the RMP-02/MTN-006 phase 1 study. PLoS One 9:e111507
Magazi, Busisiwe; Stadler, Jonathan; Delany-Moretlwe, Sinead et al. (2014) Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa. BMC Womens Health 14:88
Dezzutti, Charlene S; Russo, Julie; Wang, Lin et al. (2014) Development of HIV-1 rectal-specific microbicides and colonic tissue evaluation. PLoS One 9:e102585
Seaton, Kelly E; Ballweber, Lamar; Lan, Audrey et al. (2014) HIV-1 specific IgA detected in vaginal secretions of HIV uninfected women participating in a microbicide trial in Southern Africa are primarily directed toward gp120 and gp140 specificities. PLoS One 9:e101863
McGowan, Ian (2014) The development of rectal microbicides for HIV prevention. Expert Opin Drug Deliv 11:69-82
Balkus, Jennifer E; Richardson, Barbra A; Rabe, Lorna K et al. (2014) Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women. Sex Transm Dis 41:123-8
Yang, Kuo-Hsiung; Hendrix, Craig; Bumpus, Namandje et al. (2014) A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate. PLoS One 9:e106196
Penrose, Kerri J; Richardson, Barbra A; Besson, Guillaume et al. (2014) Y chromosome and HIV DNA detection in vaginal swabs as biomarkers of semen and HIV exposure in women. Sex Transm Dis 41:674-9
Parsons, Teresa L; Emory, Joshua F; Seserko, Lauren A et al. (2014) Dual quantification of dapivirine and maraviroc in cervicovaginal secretions from ophthalmic tear strips and polyester-based swabs via liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. J Pharm Biomed Anal 98:407-16

Showing the most recent 10 out of 19 publications