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.
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.
|Riddler, Sharon A; Husnik, Marla; Gorbach, Pamina M et al. (2016) Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015. HIV Clin Trials 17:204-11|
|van der Straten, Ariane; Panther, Lori; Laborde, Nicole et al. (2016) Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States. AIDS Behav 20:2644-2653|
|Danby, Claire S; Cosentino, Lisa A; Rabe, Lorna K et al. (2016) Patterns of Extragenital Chlamydia and Gonorrhea in Women and Men Who Have Sex With Men Reporting a History of Receptive Anal Intercourse. Sex Transm Dis 43:105-9|
|Luecke, Ellen H; Cheng, Helen; Woeber, Kubashni et al. (2016) Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study. J Int AIDS Soc 19:20875|
|Herold, Betsy C; Chen, Beatrice A; Salata, Robert A et al. (2016) Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel. Clin Infect Dis 62:375-82|
|Hartmann, Miriam; Montgomery, Elizabeth; Stadler, Jonathan et al. (2016) Negotiating the use of female-initiated HIV prevention methods in a context of gender-based violence: the narrative of rape. Cult Health Sex 18:611-24|
|Duby, Zoe; Hartmann, Miriam; Montgomery, Elizabeth T et al. (2016) Sexual scripting of heterosexual penile-anal intercourse amongst participants in an HIV prevention trial in South Africa, Uganda and Zimbabwe. Cult Health Sex 18:30-44|
|Scott, Yanille M; Park, Seo Young; Dezzutti, Charlene S (2016) Broadly Neutralizing Anti-HIV Antibodies Prevent HIV Infection of Mucosal Tissue Ex Vivo. Antimicrob Agents Chemother 60:904-12|
|Moodley, Jeeva; Naidoo, Sarita; Moodley, Jayajothi et al. (2016) Sharing of Investigational Drug Among Participants in the Voice Trial. AIDS Behav 20:2709-2714|
|Baeten, Jared M; Palanee-Phillips, Thesla; Brown, Elizabeth R et al. (2016) Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med 375:2121-2132|
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