INSIGHT'S mission is to develop strategies for the optimization of treatment -- antiretroviral therapies (ART), immunomodulatory therapies, and interventions to prevent and treat complications of HIV and ART - in order to prolong disease-free survival in a demographically, socio-economically, and geographically diverse population of individuals infected with HIV. The specific research emphasis will be """"""""optimization of clinical management, including co-morbidities,"""""""" and will be characterized by 1) Large randomized trials with morbidity and mortality outcomes, and where appropriate preceded by vanguard studies to refine design parameters;2) Studies relevant to both resource-rich and resource-poor countries;3) Studies directed at minimizing the adverse effects of long-term treatment while maximizing the benefits;4) Studies emphasizing co-enrollment so that more than one major research question can be addressed in the cohorts under followup;5) Mechanistic substudies as part of larger trials;6) Carefully planned epidemiological analyses, including nested case-control studies that take advantage of a large cross-study database and associated specimen repository;and 7) Linkages with other networks to maximize efficiency and research productivity. INSIGHT will conduct 5 or 6 large trials at approximately 400 sites in 35 countries. Through a carefully developed, cost efficient, organizational plan that emphasizes important principles - randomization, clinically relevant interventions, excellent follow-up, and centrally adjudicated outcomes, and distribution of responsibilities for international and local data quality assurance - high-quality data sets will be assembled to address important clinical management questions. The INSIGHT Coordinating and Operations Research Center (CORE) will be located at the Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, at the University of Minnesota. The CORE, co-located with the Network Laboratory and Statistical and Data Management Center, will take advantage of a streamlined organizational structure and the administrative support, resources, and services of the University. The absence of stand-alone, duplicative administrative functions at multiple network locations eliminates the related incremental costs, fosters a more responsive and unified network with minimal time invested in the coordination of activities by network components, and builds on the economies of scale that can be realized by combining essential activities and sharing resources.

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 #
5UM1AI068641-09
Application #
8653519
Study Section
Special Emphasis Panel (ZAI1-HSD-A (J1))
Program Officer
Decarlo, Ellen S
Project Start
2006-06-29
Project End
2015-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
9
Fiscal Year
2014
Total Cost
$28,222,080
Indirect Cost
$1,556,251
Name
University of Minnesota Twin Cities
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Grady, Christine; Touloumi, Giota; Walker, A Sarah et al. (2017) A randomized trial comparing concise and standard consent forms in the START trial. PLoS One 12:e0172607
Murray, Daniel D; Suzuki, Kazuo; Law, Matthew et al. (2017) Circulating miR-122 and miR-200a as biomarkers for fatal liver disease in ART-treated, HIV-1-infected individuals. Sci Rep 7:10934
Baker, Jason V; Sharma, Shweta; Grund, Birgit et al. (2017) Systemic Inflammation, Coagulation, and Clinical Risk in the START Trial. Open Forum Infect Dis 4:ofx262
Baker, Jason V; Sharma, Shweta; Achhra, Amit C et al. (2017) Changes in Cardiovascular Disease Risk Factors With Immediate Versus Deferred Antiretroviral Therapy Initiation Among HIV-Positive Participants in the START (Strategic Timing of Antiretroviral Treatment) Trial. J Am Heart Assoc 6:
Hodgson, Shane; Griffin, Timothy J; Reilly, Cavan et al. (2017) Plasma sphingolipids in HIV-associated chronic obstructive pulmonary disease. BMJ Open Respir Res 4:e000180
Borges, Álvaro H (2017) Combination antiretroviral therapy and cancer risk. Curr Opin HIV AIDS 12:12-19
Lifson, Alan R; Grund, Birgit; Gardner, Edward M et al. (2017) Improved quality of life with immediate versus deferred initiation of antiretroviral therapy in early asymptomatic HIV infection. AIDS 31:953-963
Achhra, Amit C; Mocroft, Amanda; Ross, Michael et al. (2017) Impact of early versus deferred antiretroviral therapy on estimated glomerular filtration rate in HIV-positive individuals in the START trial. Int J Antimicrob Agents 50:453-460
O'Connor, Jemma; Vjecha, Michael J; Phillips, Andrew N et al. (2017) Effect of immediate initiation of antiretroviral therapy on risk of severe bacterial infections in HIV-positive people with CD4 cell counts of more than 500 cells per ?L: secondary outcome results from a randomised controlled trial. Lancet HIV 4:e105-e112
Baker, Jason V; Hullsiek, Katherine Huppler; Engen, Nicole Wyman et al. (2016) Early Antiretroviral Therapy at High CD4 Counts Does Not Improve Arterial Elasticity: A Substudy of the Strategic Timing of AntiRetroviral Treatment (START) Trial. Open Forum Infect Dis 3:ofw213

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