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.

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 #
1UM1AI106707-01
Application #
8554419
Study Section
Special Emphasis Panel (ZAI1-RRS-A (S1))
Program Officer
Black, Roberta J
Project Start
2014-01-01
Project End
2020-11-30
Budget Start
2014-01-01
Budget End
2014-11-30
Support Year
1
Fiscal Year
2014
Total Cost
$2,386,061
Indirect Cost
$554,017
Name
Magee-Women's Research Institute and Foundation
Department
Type
DUNS #
119132785
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Giguere, Rebecca; Brown III, William; Balán, Ivan C et al. (2018) Are participants concerned about privacy and security when using short message service to report product adherence in a rectal microbicide trial? J Am Med Inform Assoc 25:393-400
Giguere, Rebecca; Rael, Christine Tagliaferri; Sheinfil, Alan et al. (2018) Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav 22:388-401
Brown 3rd, William; Giguere, Rebecca; Sheinfil, Alan et al. (2018) Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017). J Biomed Inform 80:78-86
Abbai, Nathlee S; Nyirenda, Makandwe; Naidoo, Sarita et al. (2018) Prevalent Herpes Simplex Virus-2 Increases the Risk of Incident Bacterial Vaginosis in Women from South Africa. AIDS Behav 22:2172-2180
Hughes, Sean M; Ferre, April L; Yandura, Sarah E et al. (2018) Cryopreservation of human mucosal tissues. PLoS One 13:e0200653
Laborde, Nicole D; Pleasants, Elizabeth; Reddy, Krishnaveni et al. (2018) Impact of the Dapivirine Vaginal Ring on Sexual Experiences and Intimate Partnerships of Women in an HIV Prevention Clinical Trial: Managing Ring Detection and Hot Sex. AIDS Behav 22:437-446
Montgomery, Elizabeth T; Noguchi, Lisa M; Dai, James Y et al. (2018) Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States. AIDS Behav 22:402-411
Justman, Jessica E; Nair, Gonasagrie Lulu; Hendrix, Craig W et al. (2018) Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing. J Acquir Immune Defic Syndr 78:175-182
Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E et al. (2018) Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials 19:8-14
Balkus, Jennifer E; Brown, Elizabeth R; Palanee-Phillips, Thesla et al. (2018) Performance of a Validated Risk Score to Predict HIV-1 Acquisition Among African Women Participating in a Trial of the Dapivirine Vaginal Ring. J Acquir Immune Defic Syndr 77:e8-e10

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