The Harvard/Boston/Providence Clinical Trial Unit (CTU) will be established to conduct clinical trials to address research areas of four NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN);integrated HIV prevention strategies (HPTN);microbicidal HIV prevention strategies (MTN);and adult HIV therapeutic strategies including HIV cure, management of non-infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU will be comprised of seven clinical research sites (CRSs) at institutions where the clinical trials will be conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Fenway Health Center, Boston Medical Center, and Miriam Hospital. The CTU will be led by three highly experienced PIs, Drs. Raphael Dolin, Kenneth Mayer, and Daniel Kuritzkes, and will include highly accomplished CRS leaders and collaborating investigators. The CTU will function as an integrated, highly collaborative entity, which will have centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions will be driven by a rigorous evaluation process based on established metrics of performance and robust communication among leadership and staff of the CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory, a Research Pharmacy Coordinator, Data and Quality Management Plans, and a Community Engagement Core. The CTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS, hepatitis C virus infection and tuberculosis, and have well-grounded connections with the communities in which they are based. The CTU is well poised to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure will facilitate the conduct of studies which cross traditional network boundaries and will enable rapid responses to new scientific directions as they emerge.

Public Health Relevance

The Harvard/Boston/Providence Clinical Trial Unit will carry out clinical trials that address major questions in HIV clinical research. The results of the studies will lead to major improvements in ways to treat and prevent HIV infection and related diseases.

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 #
2UM1AI069412-08
Application #
8609770
Study Section
Special Emphasis Panel (ZAI1-RB-A (S1))
Program Officer
Bupp, Jane E
Project Start
2007-01-15
Project End
2020-11-30
Budget Start
2013-12-10
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$3,334,342
Indirect Cost
$228,467
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
Nixon, Daniel E; Bosch, Ronald J; Chan, Ellen S et al. (2017) Effects of atorvastatin on biomarkers of immune activation, inflammation, and lipids in virologically suppressed, human immunodeficiency virus-1-infected individuals with low-density lipoprotein cholesterol <130 mg/dL (AIDS Clinical Trials Group Study A52 J Clin Lipidol 11:61-69
Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial. Ann Intern Med 167:384-393
Gandhi, Rajesh T; McMahon, Deborah K; Bosch, Ronald J et al. (2017) Levels of HIV-1 persistence on antiretroviral therapy are not associated with markers of inflammation or activation. PLoS Pathog 13:e1006285
Giguere, Rebecca; Rael, Christine Tagliaferri; Sheinfil, Alan et al. (2017) Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav :
Carballo-Diéguez, Alex; Balán, Ivan C; Brown 3rd, William et al. (2017) High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One 12:e0181607
Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Phase 2 Study of the Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Men Who Have Sex With Men (HPTN 069/ACTG A5305). J Infect Dis 215:238-246
Parker, Robert A; Rabideau, Dustin J; Sax, Paul E et al. (2017) Impact of Medication Adherence on Virologic Failure in A5202: A Randomized, Partially Blinded, Phase 3B Study. Clin Infect Dis 64:1612-1614
Cranston, Ross D; Lama, Javier R; Richardson, Barbra A et al. (2017) MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel. Clin Infect Dis 64:614-620
Kiser, Jennifer J; Lu, Darlene; Rosenkranz, Susan L et al. (2017) Boceprevir and Antiretroviral Pharmacokinetic Interactions in HIV/HCV Co-infected Persons: AIDS Clinical Trials Group Study A5309s. Drugs R D 17:557-567
Boyer, Cherrie B; Greenberg, Lauren; Chutuape, Kate et al. (2017) Exchange of Sex for Drugs or Money in Adolescents and Young Adults: An Examination of Sociodemographic Factors, HIV-Related Risk, and Community Context. J Community Health 42:90-100

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