Fred Gordin Chief, Infectious Diseases Veterans Affairs Medical Center; Washington DC Professor of Medicine; The George Washington University Phone: (202)

 Total funding to Leadership Groups and Clinical Trials Units $270-$300 million yearly.  Grant duration – 7 years 2006 NIH Recompetition of All DAIDS Networks

Translational Research / Drug Development Mother to Child Transmission Microbicides HIV Vaccines Prevention of HIV Infection Optimization of Clinical Management including Co-Morbidities DAIDS Priority Research Areas for Leadership Groups

INSIGHT Network Structure Argentina Australia Chile Israel Japan New Zealand Thailand Brazil Canada Peru South Africa United States 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 Washington ICC* Sydney ICC Copenhagen ICC London ICC Minnesota Coordinting Center INSIGHT Executive Committee *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

 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) Clinical Trials Units (CTUs)

CPCRA CTU Structure - 1

The proposed CPCRA CTU: 23 Site Coordinating Centers, 137 Clinical Research Sites Brazil, Rio SCC 6 Brazil, Sao Paulo 7 Canada SCC 14 Peru SCC 2 South Africa SCC 1 US Bronx SCC 4 US Chicago SCC 5 US CORNET SCC 6 US Denver SCC 10 US Florida SCC 4 US Harlem SCC 6 US Henr Ford SCC 3 US Houston SCC 5 US Los Ang SCC 4 US Louisiana SCC 7 US New Eng SCC 6 US No. Jersey SCC 7 US Portland SCC 7 US Richmond SCC 10 US San Fran SCC 9 US So. Jersey SCC 6 US Wash’ton SCC 6 US Wayne Sta SCC 2 n

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