The past few years have seen remarkable progress in the HIV prevention field. Topical microbicides have had their first, modest demonstration of efficacy in women using tenofovir gel. Throughout the last six years the Microbicide Trials Network (MTN) has laid a foundation of additional studies to gird the clinical microbicide infrastructure. Over the next seven years, the MTN plans to expand the drugs and dosage forms brought into HIV prevention and we will focus our efforts on populations that are at high risk for HIV acquisition. As the Laboratory Center (LC) for the MTN we will provide laboratory oversight for the MTN scientific agenda to ensure compliance of all laboratories to good clinical laboratory practice. Additionally, the MTN LC will work with all NIH-sponsored HIV clinical trial networks and NIH contractors to harmonize laboratory methods and maximize the efficiency of protocol implementation. This will develop clear lines of communication between the MTN LC and associated Clinical Trials Units/Clinical Research Sites laboratories. Secondly, the MTN LC will work with the MTN Leadership Group and Statistical and Data Management Center to ensure the MTN scientific agenda continues to be responsive to protocol requirements for product safety and anticipated product efficacy. To accomplish our mission, the MTN LC will rely on three Core Laboratories: the Protocol Support Core led by Dr. Charlene Dezzutti along with Drs. Lisa Rohan, Sharon Hillier and lan McGowan who will provide their expertise for product testing, site support, sexually transmitted disease diagnoses, mucosal flora monitoring, mucosal immunity, and systems biology;the Virology Core led by Dr. John Mellors and Dr. Urvi Parikh who will provide the daily oversight for the HIV endpoint and drug resistance testing - primary endpoints for our protocols;and the Pharmacology Core led by Drs. Craig Hendrix and Peter Anderson who will provide their expertise for analyte analysis and assay development and define how much drug reaches the target tissue/cells and how long it remains - critical questions for topical microbicide development. Together, this remarkable team will strive to bring to licensure a safe and effective topical microbicide.

Public Health Relevance

Despite over 30 years into the HIV epidemic, modest advances have been to help people protect themselves from getting infected. The work done by the Microbicide Trials Network will bring forward new drugs and new ways to use them to prevent people from getting HIV. To do this, work will be done by a group of dedicated scientists to make sure safe and potent products are tested.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-RRS-A (S1))
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Black, Roberta J
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Magee-Women's Research Institute and Foundation
United States
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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
Parikh, Urvi M; Mellors, John W (2016) Should we fear resistance from tenofovir/emtricitabine preexposure prophylaxis? Curr Opin HIV AIDS 11:49-55
Dai, James Y; Hendrix, Craig W; Richardson, Barbra A et al. (2016) Pharmacological Measures of Treatment Adherence and Risk of HIV Infection in the VOICE Study. J Infect Dis 213:335-42
Beigi, Richard H; Noguchi, Lisa M; Montgomery, Elizabeth et al. (2016) A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy. J Int AIDS Soc 19:20990

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