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.

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-HSD-A (J1))
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Decarlo, Ellen S
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University of Minnesota Twin Cities
Biostatistics & Other Math Sci
Schools of Public Health
United States
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Borges, Alvaro H; O'Connor, Jemma L; Phillips, Andrew N et al. (2014) Factors associated with D-dimer levels in HIV-infected individuals. PLoS One 9:e90978
Lucas, G M; Cozzi-Lepri, A; Wyatt, C M et al. (2014) Glomerular filtration rate estimated using creatinine, cystatin C or both markers and the risk of clinical events in HIV-infected individuals. HIV Med 15:116-23
Cummins, Nathan W; Neuhaus, Jacqueline; Sainski, Amy M et al. (2014) Short communication: CD4 T cell declines occurring during suppressive antiretroviral therapy reflect continued production of Casp8p41. AIDS Res Hum Retroviruses 30:476-9
Kunisaki, Ken M (2014) Will expanded ART use reduce the burden of HIV-associated chronic lung disease? Curr Opin HIV AIDS 9:27-33
Dawood, Farah Z; Roediger, Mollie P; Grandits, Greg et al. (2014) Determinants of developing widened spatial QRS-T angle in HIV-infected individuals: results from the Strategies for Management of Antiretroviral Therapy [SMART] Study. J Electrocardiol 47:264-71
Lifson, Alan R; Nelson, Ray; Prineas, Ronald J et al. (2014) Re: "Lessons learned from the design and implementation of myocardial infarction adjudication tailored for HIV clinical cohorts". Am J Epidemiol 180:449
Béténé A Dooko, Claude; De Wit, Stephane; Neuhaus, Jacqueline et al. (2014) Interleukin-6, high sensitivity C-reactive protein, and the development of type 2 diabetes among HIV-positive patients taking antiretroviral therapy. J Acquir Immune Defic Syndr 67:538-46