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 #
5UM1AI068641-07
Application #
8288912
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
2012-06-01
Budget End
2013-05-31
Support Year
7
Fiscal Year
2012
Total Cost
$12,481,750
Indirect Cost
$2,451,929
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
Lodi, Sara; Sharma, Shweta; Lundgren, Jens D et al. (2016) The per-protocol effect of immediate vs. deferred ART initiation in the START randomized trial. AIDS :
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
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
Borges, Álvaro H; Neuhaus, Jacqueline; Babiker, Abdel G et al. (2016) Immediate Antiretroviral Therapy Reduces Risk of Infection-Related Cancer During Early HIV Infection. Clin Infect Dis 63:1668-1676
French, Martyn A; Cozzi-Lepri, Alessandro; Arduino, Roberto C et al. (2015) Plasma levels of cytokines and chemokines and the risk of mortality in HIV-infected individuals: a case-control analysis nested in a large clinical trial. AIDS 29:847-51
Law, M G; Achhra, A; Deeks, S G et al. (2015) Clinical and demographic factors associated with low viral load in early untreated HIV infection in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med 16 Suppl 1:37-45
Soliman, E Z; Sharma, S; Arastéh, K et al. (2015) Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med 16 Suppl 1:46-54
INSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group; Lundgren, Jens; Babiker, Abdel et al. (2015) Why START? Reflections that led to the conduct of this large long-term strategic HIV trial. HIV Med 16 Suppl 1:1-9
Achhra, A C; Mocroft, A; Ross, M J et al. (2015) Kidney disease in antiretroviral-naïve HIV-positive adults with high CD4 counts: prevalence and predictors of kidney disease at enrolment in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med 16 Suppl 1:55-63
Baker, J V; Engen, N W; Huppler Hullsiek, K et al. (2015) Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med 16 Suppl 1:109-18

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