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Review of the HIVNET 012 Perinatal HIV Prevention Study (2005)

Chapter: Appendix A: Agendas of Information-Gathering Meetings

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Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
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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

Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×

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

Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×

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

Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×

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

Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×
Page 109
Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×
Page 110
Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×
Page 111
Suggested Citation:"Appendix A: Agendas of Information-Gathering Meetings." Institute of Medicine. 2005. Review of the HIVNET 012 Perinatal HIV Prevention Study. Washington, DC: The National Academies Press. doi: 10.17226/11264.
×
Page 112
Next: Appendix B: Comparisons to Other Perinatal HIV Prevention Studies Using NVP and AZT »
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Mother-to-child transmission of HIV-1 afflicts hundreds of thousands of children every year, especially in parts of the world such as sub-Saharan Africa, where HIV infection is prevalent and resources are limited. This tragic reality has spurred researchers to search for an effective, safe, and inexpensive treatment that could reduce the risk of perinatal HIV transmission. The HIVNET 012 trial was designed to provide preliminary information on the comparative safety and efficacy of two relatively simple and inexpensive short courses of oral antiretroviral treatment likely to be feasible in resource-limited settings.

The resulting report identified some problems with procedures and documentation, but concluded that these issues did not compromise the results of the study. However, these issues have led to public scrutiny and continued controversy. Review of the HIVNET 012 Perinatal HIV Prevention Study critically and objectively evaluates the study's design and conduct, and assesses the impact of the initial procedural issues on the validity of the overall findings and conclusions of the trial.

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