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Review of the HIVNET 012 Perinatal HIV Prevention Study
Appendix A
Agendas of Information-Gathering Meetings
Meeting One
September 30, 2004
The National Academy of Sciences Building
2100 C St., N.W., Board Room
Washington, D.C.
8:45-9:15 a.m.
Registration
9:15-9:30 a.m.
Welcome, Introductions, and Opening Statement
Stephen Lagakos, Ph.D.
IOM Committee Member
9:30-9:45 a.m.
Charge to the Committee (via phone)
Ruth Kirschstein, M.D.
Senior Advisor to the Director
National Institutes of Health
9:45-10:00 a.m.
Questions from the Committee
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Review of the HIVNET 012 Perinatal HIV Prevention Study
10:00-10:45 a.m.
Overview of HIVNET 012 Trial
J. Brooks Jackson, M.D., M.B.A.
HIVNET 012 Principal Investigator
Johns Hopkins University
Laura Guay, M.D.
HIVNET 012 Co-Investigator
Johns Hopkins University
Tom Fleming, Ph.D.
HIVNET 012 Co-Investigator
University of Washington
10:45-11:15 a.m.
Questions from the Committee
11:15-11:45 a.m.
Review of Perinatal HIV Prevention Trials Involving Nevirapine: Safety and Efficacy Data
Lynne Mofenson, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
National Institutes of Health
11:45 a.m.-12:00
Questions from the Committee
12:00-1:00 p.m.
Lunch
1:00-1:30 p.m.
NIH Remonitoring Study of HIVNET 012
John LaMontagne, Ph.D.
Deputy Director
National Institute of Allergy and Infectious Diseases
National Institutes of Health
1:30-2:00 p.m.
Questions from the Committee
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Review of the HIVNET 012 Perinatal HIV Prevention Study
2:00-2:45 p.m.
Comments from HIVNET 012 Investigators on NIH Remonitoring Study
J. Brooks Jackson, M.D., M.B.A.
HIVNET 012 Principal Investigator
Johns Hopkins University
Laura Guay, M.D.
HIVNET 012 Co-Investigator
Johns Hopkins University
Tom Fleming, Ph.D.
HIVNET 012 Co-Investigator
University of Washington
2:45-3:15 p.m.
Questions from the Committee
3:15-3:55 p.m.
Public Comment Period
3:55-4:00 p.m.
Closing Remarks
Stephen Lagakos, Ph.D.
IOM Committee Member
4:00 p.m.
Adjourn
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Review of the HIVNET 012 Perinatal HIV Prevention Study
Meeting Three
January 4, 2005
Keck Center of the National Academies
500 Fifth Street, N.W., Room 201
Washington, DC
10:00-10:05 a.m.
Opening Remarks
James Ware, Ph.D.
IOM Committee Chair
10:05-10:45 a.m.
Comments on the HIVNET 012 Perinatal HIV Prevention Trial
Jonathan Fishbein, M.D. (Former Director of Office for Policy in Clinical Research Operations, Division of AIDS, NIAID, NIH)
10:45-11:15 a.m.
Questions from the committee
Representative terms from entire chapter:
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