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--Cooperative Agreements (U01)
Project #
5U01AI068641-05
Application #
7888381
Study Section
Special Emphasis Panel (ZAI1-HSD-A (J1))
Program Officer
Decarlo, Ellen S
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2010-06-01
Budget End
2011-05-31
Support Year
5
Fiscal Year
2010
Total Cost
$27,129,434
Indirect Cost
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
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Hart, Brian B; Nordell, Anna D; Okulicz, Jason F et al. (2018) Inflammation-Related Morbidity and Mortality Among HIV-Positive Adults: How Extensive Is It? J Acquir Immune Defic Syndr 77:1-7
Hoy, Jennifer F; Grund, Birgit; Roediger, Mollie et al. (2017) Immediate Initiation of Antiretroviral Therapy for HIV Infection Accelerates Bone Loss Relative to Deferring Therapy: Findings from the START Bone Mineral Density Substudy, a Randomized Trial. J Bone Miner Res 32:1945-1955
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Dwyer, Dominic E; Lynfield, Ruth; Losso, Marcelo H et al. (2017) Comparison of the Outcomes of Individuals With Medically Attended Influenza A and B Virus Infections Enrolled in 2 International Cohort Studies Over a 6-Year Period: 2009-2015. Open Forum Infect Dis 4:ofx212
Larson, Gregg S; Carey, Cate; Grarup, Jesper et al. (2016) Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials 13:127-36
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O'Connor, J L; Gardner, E M; Esser, S et al. (2016) A simple self-reported adherence tool as a predictor of viral rebound in people with viral suppression on antiretroviral therapy. HIV Med 17:124-32
Borges, Álvaro H; O'Connor, Jemma L; Phillips, Andrew N et al. (2016) Interleukin 6 Is a Stronger Predictor of Clinical Events Than High-Sensitivity C-Reactive Protein or D-Dimer During HIV Infection. J Infect Dis 214:408-16
Cummins, Nathan W; Neuhaus, Jacqueline; Chu, Haitao et al. (2015) Investigation of Efavirenz Discontinuation in Multi-ethnic Populations of HIV-positive Individuals by Genetic Analysis. EBioMedicine 2:706-12

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