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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI068633-08
Application #
8554615
Study Section
Special Emphasis Panel (ZAI1-RRS-A (S1))
Program Officer
Black, Roberta J
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2014-01-01
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$7,036,839
Indirect Cost
$1,192,835
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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McGowan, Ian (2014) The development of rectal microbicides for HIV prevention. Expert Opin Drug Deliv 11:69-82
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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

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