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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OCR for page 109
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

OCR for page 109
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

OCR for page 109
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

OCR for page 109
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