INSIGHT'S mission is to develop strategies for the optimization of treatment -- antiretroviral therapies (ART), immunomodulatory therapies, and interventions to prevent andtreat complications of HIVand ART- inorder 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 follow- up; 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, implementing the plan in a cost-effective way with emphasis on important principles ~ randomization, clinically relevant interventions, excellent long-term follow-up, and centrally adjudicated clinical outcomes. Through a carefully developed organizational plan that distributes responsibilities for international and local data quality assurance, high- quality data sets will be assembled to address important clinical management questions. With experienced investigators, collaborations with other networks, and the guidance of consultants in specialized areas, substantial and timely contributions will be made to the scientific literature and medical practice guidelines. These contributions will advance the DAIDS mission to promote progress in treatment - the discovery and development of therapies for HIV infection and its complications. The INSIGHT Leadership application includes three components: 1) Coordinating and Research Operations Center (CORE), 2) Network Laboratory (NL), and 3) Statistical and Data Management Center (SDMC). All three components will be colocated at the Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, at the University of Minnesota.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AI068641-02S1
Application #
7583335
Study Section
Special Emphasis Panel (ZAI1-HSD-A (J1))
Program Officer
Howell Simmonds, Kimberly
Project Start
2008-01-01
Project End
2008-05-31
Budget Start
2008-01-01
Budget End
2008-05-31
Support Year
2
Fiscal Year
2008
Total Cost
$4,078,460
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
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
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
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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