{ rtf1 ansi ansicpg1252 deff0 deflang1033{ fonttbl{ f0 fswiss fcharset0 Arial;}} { * generator Msftedit 5.41.15.1515;} viewkind4 uc1 pard f0 fs23 INSIGHT'S mission is to develop strategies for the optimization of treatment -- antiretroviral therapies (ART), par immunomodulatory therapies, and interventions to prevent and treat complications of HIV and ART - in order par to prolong disease-free survival in a demographically, socio-economically, and geographically diverse par population of individuals infected with HIV. The specific research emphasis will be """"""""optimization of clinical par management, including co-morbidities,"""""""" and will be characterized by 1) Large randomized trials with par morbidity and mortality outcomes, and where appropriate preceded by vanguard studies to refine design par parameters; 2) Studies relevant to both resource-rich and resource-poor countries; 3) Studies directed at par minimizing the adverse effects of long-term treatment while maximizing the benefits; 4) Studies emphasizing par co-enrollment so that more than one major research question can be addressed in the cohorts under followup; par 5) Mechanistic substudies as part of larger trials; 6) Carefully planned epidemiological analyses, par including nested case-control studies that take advantage of a large cross-study database and associated par specimen repository; and 7) Linkages with other networks to maximize efficiency and research productivity. par INSIGHT will conduct 5 or 6 large trials at approximately 400 sites in 35 countries, implementing the plan in a par cost-effective way with emphasis on important principles ~ randomization, clinically relevant interventions, par excellent long-term follow-up, and centrally adjudicated clinical outcomes. Through a carefully developed par organizational plan that distributes responsibilities for international and local data quality assurance, highquality par data sets will be assembled to address important clinical management questions. With experienced par investigators, collaborations with other networks, and the guidance of consultants in specialized areas, par substantial and timely contributions will be made to the scientific literature and medical practice guidelines. par These contributions will advance the DAIDS mission to promote progress in treatment - the discovery and par development of therapies for HIV infection and its complications. par The INSIGHT Leadership application includes three components: 1) Coordinating and Research Operations par Center (CORE), 2) Network Laboratory (NL), and 3) Statistical and Data Management Center (SDMC). All par three components will be colocated at the Coordinating Centers for Biometric Research, Division of par Biostatistics, School of Public Health, at the University of Minnesota. fs20 par par }

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AI068641-01S1
Application #
7342954
Study Section
Special Emphasis Panel (ZAI1-HSD-A (J1))
Program Officer
Howell Simmonds, Kimberly
Project Start
2006-06-29
Project End
2007-05-31
Budget Start
2007-03-01
Budget End
2007-05-31
Support Year
1
Fiscal Year
2007
Total Cost
$24,888,780
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
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
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
Grund, Birgit; Baker, Jason V; Deeks, Steven G et al. (2016) Relevance of Interleukin-6 and D-Dimer for Serious Non-AIDS Morbidity and Death among HIV-Positive Adults on Suppressive Antiretroviral Therapy. PLoS One 11:e0155100
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
Hullsiek, Katherine Huppler; Kagan, Jonathan M; Engen, Nicole et al. (2015) INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy. Ther Innov Regul Sci 49:225-233

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