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This document provides information on the total funding and research areas for the NIH Recompetition of DAIDS Networks, including microbicides, mother to child transmission, drug development, HIV vaccines, prevention of HIV infection, and optimization of clinical management. It also includes details on the INSIGHT Network structure and the CPCRA Clinical Trial Unit funding.
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Fred GordinChief, Infectious DiseasesVeterans Affairs Medical Center; Washington DCProfessor of Medicine; The George Washington UniversityFred.Gordin@va.govPhone: (202) 745-8301
2006 NIH Recompetitionof All DAIDS Networks • Total funding to Leadership Groups and Clinical Trials Units $270-$300 million yearly. • Grant duration – 7 years
DAIDS Priority Research Areasfor Leadership Groups Microbicides Mother to Child Transmission Translational Research / Drug Development HIV Vaccines Prevention of HIV Infection Optimization of Clinical Management including Co-Morbidities
Minnesota Coordinting Center INSIGHT Executive Committee Washington ICC* Sydney ICC Copenhagen ICC London ICC • Austria • Belgium • Denmark • Estonia • Finland • Germany • Lithuania • Luxembourg • Norway • Sweden • Poland • Portugal • Romania • Russia • Spain • Sweden • France • Greece • Ireland • Italy • Morocco • Netherlands • Switzerland • United Kingdom Brazil Canada Peru South Africa United States INSIGHT Network Structure Argentina Australia Chile Israel Japan New Zealand Thailand *Based at VAMC
INSIGHT Science Agenda • Strategy Trials – studies designed to have a broad impact on HIV care • Examples: • Studies of IL-2 as antiretroviral sparing • Studies of “What-to Start” • Study of “When-to Start” HIV treatment • Vaccines to prevent complications of HIV
Clinical Trials Units (CTUs) • NIH-DAIDS invited applications from CTUs to conduct clinical research • CTUs could apply and indicate affiliation with one or more Networks • The CPCRA (Community Programs for Clinical Research on AIDS) CTU affiliated both with INSIGHT (137 sites) and with HPTN (18 sites)
3 14 2 7 1 6 4 6 6 10 4 5 2 6 9 10 7 7 6 7 4 5 6 South Africa SCC US Wayne Sta SCC US New Eng SCC US Denver SCC US Chicago SCC US Florida SCC US Harlem SCC US Bronx SCC US Henr Ford SCC US Houston SCC US Los Ang SCC Brazil, Rio SCC US CORNET SCC Peru SCC US No. Jersey SCC Canada SCC US Portland SCC US Richmond SCC Brazil, Sao Paulo US San Fran SCC US So. Jersey SCC US Wash’ton SCC US Louisiana SCC The proposed CPCRA CTU: 23 Site Coordinating Centers , 137 Clinical Research Sites n SCC
CPCRA application:3642 pages 15 inches 38 pounds
CPCRA Clinical Trial Unit Funding - 1 • CPCRA Unit Scored 176 (top third of approx 120 CTU applications) • CTU awards discussed at September Council meeting with awards by Dec 2006 (or later) • No discussions with NIH yet on specifics
CPCRA Clinical Trial Unit Funding - 2 • Grant duration 5-7 years • First year funding likely $15-20 million • CTU supplemental awards for new research studies will be approved by the NIH. • When new research studies are approved, sites to do them will also be approved.
CPCRA CTU • GWU will be the grant recipient • GWU will fund multiple (>25) subcontracts • Subcontracts will go to • Site coordinating centers (SCCs) • Contract group to assist with: Web, data management, meeting planning, travel • Executive office at Washington VA