International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

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{\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 }