Multinational DSMB Agenda 2014May29-30

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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

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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