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NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
DIVISION OF AIDS (DAIDS)
MULTINATIONAL DATA AND SAFETY MONITORING BOARD
5601 Fishers Lane
Room: LD30A&B / Break-out Room: LD40
Bethesda, MD 20892
Telephone: (240) 292.4803
Fax: (240) 627.3467
Teleconference Information:
1-866-844-9416 (US toll free)
000-800-852-1217 (India toll free)
0808-238-9816 (London, UK toll free)
080-510-2764 (Paris, France toll free)
0800-53785 (Peru toll free)
080-09-82147 (South Africa toll free)
001-800-1206-66632 (Thailand toll free)
Pass code: MULTI SPRING
DRAFT AGENDA
May 14-15, 2015
Dr. Michael A. Proschan will attend all sessions representing NIAID. All times (Eastern Daylight Time) listed are approximate. Sessions may be moved forward or delayed depending on the extent of discussions.
THURSDAY, MAY 14, 2015
9:00 a.m.-9:15 a.m. EDTAdministrative Session: (CLOSED)
9:15 a.m.-11:15 a.m. EDT1077BF/FF/P1084s (PROMISE): SAFETY & EFFICACY REVIEW
1077BF (PROMISE): BREASTFEEDING VERSION OF THE PROMISE STUDY (PROMOTING MATERNAL AND INFANT SURVIVAL EVERYWHERE)
1077FF (PROMISE): FORMULA FEEDING VERSION OF THE PROMISE STUDY
P1084s (PROMISE): MATERNAL AND INFANT MONITORING FOR EVIDENCE OF TOXICITY RELATED TO TENOFOVIR EXPOSURE: THE BONE AND KIDNEY HEALTH SUBSTUDY OF THE IMPAACT 1077 PROMISE PROTOCOL
Mary Glenn Fowler, M.D., M.P.H., Study Chair 1077BF/FF
Tsungai Chipato, M.D., Study Vice Chair 1077BF/FF
James McIntyre, M.D., FRCOG, Study Vice Chair 1077BF/FF
Patricia M. Flynn, M.D., Study Vice Chair 1077BF/FF
Anna Coutsoudis, Ph.D., Infant Health Chair 1077 BF/FF
Judith Currier, M.D., M.Sc., Maternal Health Chair 1077HS/BF/FF/ Hep B Substudy Co-Chair
Lynda Stranix-Chibanda, MB ChB, MMed, Study Co-Chair P1084s
David Shapiro, Ph.D., Statistician 1077BF/FF/HS
Camlin Tierney, Ph.D., Lead Statistician Hep B Substudy
Sean Brummel, Ph.D., Statistician 1077BF/FF/HS
Mae P. Cababasay, M.S., Statistician 1077BF/FF
Konstantia Angelidou, M.S., Statistician 1077BF/FF
Terence Fenton, Ed.D., Statistician 1077BF/FF and P1084s
Meredith Warshaw, M.A., Statistician P1084s
Min Qin, Ph.D., Statistician
Sharon Huang, M.S., Statistician Hep B Substudy
Caroline Marr, M.S., Statistician 1077BF/FF
Anne Coletti, M.S., PROMISE Operations Center Representative
Kathleen George, M.P.H., FHI Clinical Trials Specialist
Katie McCarthy, M.P.H., FHI Clinical Trials Specialist
Karin L. Klingman, M.D., DAIDS Medical Officer P1077HS/BF/FF
Renee Browning, R.N., M.S.N., DAIDS Medical Officer
George K. Siberry, M.D., M.P.H., NICHD Medical Officer P1077BF/FF & P1084s Co-Chair
Rohan Hazra, M.D., NICHD Medical Officer
James F. Rooney, M.D., Gilead Sciences Representative
Devasena Gnanashanmugam, M.D., Chief, Maternal, Adolescent and Pediatric Research Branch, DAIDS
Sheryl L. Zwerski, M.S.N., C.R.N.P., Acting Director, Prevention Sciences Program, DAIDS
11:15 a.m.-11:30 a.m. EDTBREAK
11:30 a.m.-12:00 p.m. EDT 1077 HEPATITIS B / HBV SUBSTUDY (PROMISE): SAFETY & efficacy REVIEW
IMPACT OF HIV PMTCT INTERVENTIONS ON HBV DISEASE IN HIV/HBV CO-INFECTED WOMEN AND THEIR INFANTS
Mary Glenn Fowler, M.D., M.P.H., HBV Study Chair
Debika Bhattacharya, M.D., HBV Substudy Co-Chair
Judith Currier, M.D., M.Sc., HBV Substudy Co-Chair
Marion Peters M.D., HBV Substudy Co-Chair
Wendy Stevens M.D., Virologist
Camlin Tierney, Ph.D., Statistician
Sharon Huang, Statistician
Katie McCarthy, M.P.H., FHI Clinical Trials Specialist
Karin L. Klingman, M.D., DAIDS Medical Officer P1077HS/BF/FF
Renee Browning, R.N., M.S.N., DAIDS Medical Officer
George K. Siberry, M.D., M.P.H., NICHD Medical Officer
Sheryl L. Zwerski, M.S.N., C.R.N.P., Acting Director, Prevention Sciences Program, DAIDS
Sarah W. Read, M.D., M.H.S., Director, Therapeutics Research Program, DAIDS
12:00 p.m.-1:00 p.m. EDTLUNCH
1:00 p.m.-2:00 p.m. EDT1077BF/FF/P1084s (PROMISE): SAFETY & EFFICACY REVIEW (Cont.)
2:00 p.m.-3:00 p.m. EDT impAACT P1081: uPDATE
A PHASE IV RANDOMIZED TRIAL TO EVALUATE THE VIROLOGIC RESPONSE AND PHARMACOKINETICS OF THREE DIFFERENT POTENT REGIMENS IN HIV INFECTED WOMEN INITIATING TRIPLE ANTIRETROVIRAL REGIMENS BETWEEN 28 AND 36 WEEKS OF PREGNANCY FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION
Esau Custodio Joao Filho, M.D., Study Co-Chair
Mark Mirochnick, M.D., Study Co-Chair
David E. Shapiro, Ph.D., Statistician
Meredith Warshaw, M.S.S., M.A., Statistician
Katie McCarthy, M.P.H., FHI Clinical Trials Specialist
Ellen Townley O’Gara, M.S.N., F.N.P., HJF-DAIDS Medical Officer
Betsy Smith, M.D., DAIDS Medical Officer
Nahida Chakhtoura,, M.D., Ms.G.H., NICHD Medical Officer
Sheryl L. Zwerski, M.S.N., C.R.N.P., Acting Director, Prevention Sciences Program, DAIDS
3:00 p.m.-3:30 p.m. EDT Administrative Session (Closed): Adjourn
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
DIVISION OF AIDS (DAIDS)
MULTINATIONAL DATA AND SAFETY MONITORING BOARD
5601 Fishers Lane
Room: LD30A&B / Break-out Room: LD40
Bethesda, MD 20892
Telephone: (240) 292.4803
Fax: (240) 627.3467
Teleconference Information:
1-866-844-9416 (US toll free)
000-800-852-1217 (India toll free)
0808-238-9816 (London, UK toll free)
080-510-2764 (Paris, France toll free)
0800-53785 (Peru toll free)
080-09-82147 (South Africa toll free)
001-800-1206-66632 (Thailand toll free)
Pass code: MULTI SPRING
DRAFT AGENDA
May 14-15, 2015
Dr. Michael A. Proschan will attend all sessions representing NIAID. All times (Eastern Daylight Time) listed are approximate. Sessions may be moved forward or delayed depending on the extent of discussions.
FRIDAY, MAY 15, 2015
9:00 a.m.-9:15 a.m. EDTAdministrative Session: (closed)
9:15 a.m.-11:15 a.m. EDT INSIGHT 001/START: Safety & eFFICACY REVIEW
STRATEGIC TIMING OF ANTIRETROVIRAL TREATMENT
Abdel Ghayoum Babiker, M.Sc., Ph.D., Study Co-Chair
Fred Gordin, M.D., Study Co-Chair
Jens Lundgren, M.D., Study Co-Chair
Prof. Sean Emery, B.Sc., Ph.D., Study Co-Chair
James D. Neaton, M.S., Ph.D., Principle Investigator
Andrew Phillips, Ph.D., Statistician
Birgit Grund, Ph.D., Statistician
Shweta Sharma, M.S., Statistician
Karin L Klingman, M.D., DAIDS Medical Officer
Beverly Alston, M.D., Chief, Complications and Co-Infections Research Branch, DAIDS
Carla B. Pettinelli, M.D., Ph.D., Chief, HIV Research Branch, DAIDS
Sarah W. Read, M.D., M.H.S., Director, Therapeutics Research Program, DAIDS
11:15 a.m.-11:30 a.m. EDTAdministrative Session (Closed): Adjourn/ WRAP-UP
Next Meeting Date: November 12-13, 2015
Pharmaceutical Support
1077BF/FF/ p1084S (PROMISE):ABBOTT LABORATORIES, BOEHRINGER INGELHEIM, EMCURE, GILEAD SCIENCES, INC.,
GLAXOSMITHKLINE, RESMED PHARMACEUTICALS/GLAXOSMITHKLINE BIOLOGICALS
1077 HEPATITIS B / HBV ABBOTT LABORATORIES, BOEHRINGER INGELHEIM, GILEAD SCIENCES, INC.,
SUBSTUDY (PROMISE): GLAXOSMITHKLINE
IMPAACT P1081:ABBOTT LABORATORIES, BRISTOL-MYERS SQUIBB, GLAXOSMITHKLINE, INC., MERCK & cO., INC.
INSIGHT 001/START:ABBOTT LABORATORIES, BRISTOL-MYERS SQUIBB, GILEAD SCIENCES, INC., GLAXOSMITHKLINE, MERCK & CO., INC. and TIBOTEC PHARMACEUTICALS, LTD.
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Disclaimer: Conference attendees and/or presenters are responsible for meals and/or light refreshments on their own and at their own cost. Government staff and/or government contractors may not be involved in the provision or facilitation of food and/or light refreshments for conference attendees and/or presenters.