Adult ID

HIV/TB/STD

Investigative ID

Oral Abstract

293 - Clinical Trials that May Change your Practice

Presentations:

• 1:45 PM - 2:00 PM

  2838 - Safety and Immunogenicity of a gp120-CD4 Chimeric Subunit Vaccine: A Phase 1a Randomized Controlled Trial
  Joel V. Chua, MD – Institute of Human Virology, University of Maryland School of Medicine; Charles Davis, MD – Institute of Human Virology, University of Maryland School of Medicine; Amy Nelson, RN – Institute of Human Virology, University of Maryland School of Medicine; Ka Wing J. Lam – Institute of Human Virology, University of Maryland School of Medicine; Lydiah Mutumbi, RN – Institute of Human Virology, University of Maryland School of Medicine; Kristen A. Stafford, MPH, PhD – University of Maryland; Bruce Gilliam, MD – Institute of Human Virology, University of Maryland School of Medicine; Anthony L. DeVico, PhD – Institute of Human Virology, University of Maryland School of Medicine; George K. Lewis, PhD – Institute of Human Virology, University of Maryland School of Medicine; Mohammad M. Sajadi, MD – Institute of Human Virology, University of Maryland School of Medicine
• 2:00 PM - 2:15 PM

  2839 - Efficacy, Pharmacokinetics (PK), and Safety Profile of Suvratoxumab (MEDI4893), a Staphylococcus aureus Alpha Toxin (AT)-Neutralizing Human Monoclonal Antibody in Mechanically Ventilated Patients in Intensive Care Units; Results of the Phase 2 SAATELLITE Study Conducted by the Public-Private COMBACTE Consortium.
  Bruno Francois, Physician – CHU Dupuytren Limoges; Miguel Sánchez Garcia, MD, PhD – Hospital Clinico San Carlos; Philippe Eggimann, MD – University Hospital and Universits of Lausanne - Switzerland; Pierre-Francois Dequin, MD – Universite Francois Rabelais Hopital Bretonneau; Pierre-François Laterre, MD – St Luc University Hospital, University of Louvain, Brussels, Belgium; Vincent Huberlant, MD – Centre Hospitalier Jolimont-Lobbes; Lucia Viña Soria, MD – Hospital Universitario central de Asturias; Thierry Boulain, M.D. – Centre Hospitalier Régional d'Orléans, Orléans, France; Cédric Bretonnière, MD, PhD – Institut du Thorax - CHU Nantes; Jerome Pugin, MD – Hôpitaux Universitaire de Genève; José Trenado Álvarez, MD, PhD – Hospital Universitari Mutua Terrassa; Ana Catalina Hernandez Padilla – Centre Hospitalier Universitaire de Limoges, Limoges, France; Frank Coenjaerts, PhD – University Medical Center Utrecht; Omar Ali, Ph.D. – AstraZeneca; Kathryn Shoemaker, MS – AstraZeneca; Alexey Ruzin, PhD – AstraZeneca; Vadryn Pierre, PharmD – Astrazeneca; Yuling Wu, PhD – Biopharma; Susan Colbert, RN, BSN; Terramika Bellamy, MS; Michael McCarthy, MD – MedImmune; Filip Dubovsky, MD, MPH – AstraZeneca; Hasan S. Jafri, MD – AstraZeneca
• 2:15 PM - 2:30 PM

  2840 - Long Term Efficacy, Safety and Durability of CAB and RPV as Two Drug Oral Maintenance Therapy – LATTE Week 312 Results
  David Margolis, MD, MPH – ViiV Healthcare; Kenneth Sutton, MA – ViiV Healthcare; Jerome De Vente, MD – Long Beach Education and Research Consultants; Roger LeBlanc, MD – Clinique OPUS INC.; Edwin DeJesus, MD – Orlando Immunology Center, University of Central Florida College of Medicine; Graham Smith, MD, MSc – Maple Leaf Medical CLinic; Anthony Mills, MD – Men’s Health Foundation; Jean-Guy Baril, MD – Clinique Medicale Quartier Latin; Marty St. Clair – ViiV Healthcare; Britt Stancil, BS in Statistics – GSK; Peter Williams, Ph.D. – Janssen Research & Development, LLC; William Spreen, PharmD – ViiV Healthcare
• 2:30 PM - 2:45 PM

  2841 - A Phase 3, Randomized, Double-Blind Study Comparing Tedizolid Phosphate (TZD) and Linezolid (LZD) for Treatment of Ventilated Gram-Positive (G+) Nosocomial Pneumonia
  Richard G. Wunderink, MD – Northwestern University Feinberg School of Medicine; Antoine Roquilly, MD, PhD – CHU Nantes; Martin Croce, MD – Regional One Health; Daniel Rodriguez Gonzalez, MD – Nuevo Hospital Civil de Guadalajara; Satoshi Fujimi, MD, PhD – Osaka General Medical Center; Joan R. Butterton, MD – Merck & Co., Inc.; Natasha Broyde, MS – Merck & Co., Inc.; Myra W. Popejoy, PharmD – Merck & Co., Inc.; Jason Y. Kim, MD, MSCE – Merck & Co., Inc.; Carisa S. De Anda, PharmD – Merck & Co., Inc.
• 2:45 PM - 3:00 PM

  2842 - Durable Efficacy of Two-Drug Regimen (2DR) of Dolutegravir (DTG) plus Lamivudine (3TC) in Antiretroviral Treatment-Naïve Adults with HIV-1 Infection at 96 Weeks: Subgroup Analyses in the GEMINI Studies
  Jean A. van Wyk, MB,ChB – ViiV Healthcare; Choy Y. Man, BSc – ViiV Healthcare; Jörg Sievers, DPhil – ViiV Healthcare; Rimgaile Urbaityte, MSc – GSK; Mark Underwood, PhD – ViiV Healthcare; Allan R. Tenorio, MD – ViiV Healthcare; Keith Pappa, PharmD – ViiV Healthcare; Brian Wynne, MD – ViiV Healthcare; Kimberly Smith, MD – ViiV Healthcare; Martin Gartland, PhD – ViiV Healthcare

Co-Author(s)

• RW

  Richard Wunderink, MD

  Dr.
  Northwestern University Feinberg School of Medicine
  Chicago, IL

  Disclosure: Arsanis: Consultant, Other Financial or Material Support, Institution received funding for clinical trial enrollment. RGW received consultation fees for clinical trial design
  KBP Biosciences: Consultant
  Meiji-Seiko: Consultant
  Melinta/The Medicines Company: Consultant, Other Financial or Material Support, Institution received funding for clinical trial enrollment. RGW received consultation fees for clinical trial design
  Merck: Consultant, Institution received funding for clinical trial enrollment. RGW received consultation fees for clinical trial design
  Microbiotix: Consultant
  Pfizer: Advisor or Review Panel member
  Polyphor: Other Financial or Material Support, Institution received funding for clinical trial enrollment. RGW received consultation fees for clinical trial design
  Shionogi: Consultant, Other Financial or Material Support, Institution received funding for clinical trial enrollment. RGW received consultation fees for clinical trial design
• CD

  Charles Davis, MD

  Associate Professor
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• CM

  Choy Man, BSc

  Ms.
  ViiV Healthcare
  Durham, NC

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• AR

  Antoine Roquilly, MD, PhD

  Anesthésiste réanimateur
  CHU Nantes
  Nantes, Lorraine, France

  Disclosure: Biomerieux: Consultant, Grant/Research Support
  Merck & Co., Inc.: Grant/Research Support, Research Grant or Support, Other Financial or Material Support, Personal fees during the study
• MS

  Miguel Sánchez Garcia, MD, PhD

  Director
  Hospital Clinico San Carlos
  Madrid, Madrid, Spain

  Disclosure: Nothing to disclose
• KS

  Kenneth Sutton, MA

  Clinical Development Manager
  ViiV Healthcare
  Research Triangle Park, North Carolina

  Disclosure: ViiV Healthcare: Employee, Shareholder
• MC

  Martin Croce, MD

  Professor and Chief, Department of Surgery
  Regional One Health
  Memphis, TN

  Disclosure: Nothing to disclose
• JD

  Jerome De Vente, MD

  Principle Investigator
  Long Beach Education and Research Consultants
  Long Beach, California

  Disclosure: Nothing to disclose
• PE

  Philippe Eggimann, MD

  MD
  University Hospital and Universits of Lausanne - Switzerland
  Lausanne, Vaud, Switzerland

  Disclosure: Nothing to disclose
• AN

  Amy Nelson, RN

  Research Nurse Coordinator
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• JS

  Jörg Sievers, DPhil

  Clinical Development Director
  ViiV Healthcare
  Brentford, England, United Kingdom

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• PD

  Pierre-Francois Dequin, MD

  Professor
  Universite Francois Rabelais Hopital Bretonneau
  Tours, Centre, France

  Disclosure: Nothing to disclose
• KL

  Ka Wing Lam

  Research Study Coordinator
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• RL

  Roger LeBlanc, MD

  President and co-founder, Director of Medicine and the Director of Clinical Research.
  Clinique OPUS INC.
  Montreal, QC, Canada

  Disclosure: Nothing to disclose
• DR

  Daniel Rodriguez Gonzalez, MD

  Internista
  Nuevo Hospital Civil de Guadalajara
  Guadalajara, Jalisco, Mexico

  Disclosure: Nuevo Hospital Civil de Guadalajara Dr Juan I Menchaca: Scientific Research Study Investigator
• RU

  Rimgaile Urbaityte, MSc

  Manager, Statistics
  GSK
  Uxbridge, England, United Kingdom

  Disclosure: GSK: Employee, Shareholder
• ED

  Edwin DeJesus, MD

  Medical Director
  Orlando Immunology Center, University of Central Florida College of Medicine
  Orlando, FL

  Disclosure: Gilead Sciences: Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support
  Janssen Infectious Diseases: Scientific Research Study Investigator, Advisor or Review Panel member
  Merck: Scientific Research Study Investigator
  Theratechnologies: Scientific Research Study Investigator, Advisor or Review Panel member
  ViiV Healthcare: Scientific Research Study Investigator
• SF

  Satoshi Fujimi, MD, PhD

  Chief Director
  Osaka General Medical Center
  Sumiyoshi-ku, Osaka, Japan

  Disclosure: Nothing to disclose
• PL

  Pierre-François Laterre, MD

  Prof
  St Luc University Hospital, University of Louvain, Brussels, Belgium
  Brussels, Brussels Hoofdstedelijk Gewest, Belgium

  Disclosure: Nothing to disclose
• LM

  Lydiah Mutumbi, RN

  Research Nurse Coordinator
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• MU

  Mark Underwood, PhD

  Clinical Development Investigator, Clinical Virology
  ViiV Healthcare
  Durham, NC

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• JB

  Joan Butterton, MD

  Associate Vice President
  Merck & Co., Inc.
  Kenilworth, NJ

  Disclosure: Merck & Co., Inc.: Employee, Shareholder
• VH

  Vincent Huberlant, MD

  MD
  Centre Hospitalier Jolimont-Lobbes
  Jolimont-Lobbes, Hainaut, Belgium

  Disclosure: Nothing to disclose
• GS

  Graham Smith, MD, MSc

  Dr
  Maple Leaf Medical CLinic
  Toronto, ON, Canada

  Disclosure: Nothing to disclose
• KS

  Kristen Stafford, MPH, PhD

  Assistant Professor
  University of Maryland
  Baltimore, MD

  Disclosure: Nothing to disclose
• AT

  Allan Tenorio, MD

  Medical Director
  ViiV Healthcare
  Durham, NC

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• NB

  Natasha Broyde, MS

  Principal Biostatistician
  Merck & Co., Inc.
  Kenilworth, NJ

  Disclosure: Merck & Co., Inc.: Employee
• BG

  Bruce Gilliam, MD

  Clinical Professor
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• AM

  Anthony Mills, MD

  Chief Medical Officer
  Men’s Health Foundation
  Los Angeles, California

  Disclosure: Gilead: Grant/Research Support, Advisor or Review Panel member
  Janssen: Grant/Research Support, Advisor or Review Panel member
  Merck: Grant/Research Support, Advisor or Review Panel member
  ViiV Healthcare: Grant/Research Support, Advisor or Review Panel member
• KP

  Keith Pappa, PharmD

  Clinical Develeopment Strategy lead
  ViiV Healthcare
  Durham, NC

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• LV

  Lucia Viña Soria, MD

  Physician
  Hospital Universitario central de Asturias
  Oviedo, Asturias, Spain

  Disclosure: Nothing to disclose
• JB

  Jean-Guy Baril, MD

  Physician
  Clinique Medicale Quartier Latin
  Montreal, QC, Canada

  Disclosure: Gilead: Consultant, Grant/Research Support
  Merk: Consultant
  ViiV Healthcare: Board Member, Consultant, Grant/Research Support
• TB

  Thierry Boulain, M.D.

  Dr, Head of department
  Centre Hospitalier Régional d'Orléans, Orléans, France
  Orléans, Centre, France

  Disclosure: Nothing to disclose
• AD

  Anthony DeVico, PhD

  Professor
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• MP

  Myra Popejoy, PharmD

  Associate Principal Clinical Scientist
  Merck & Co., Inc.
  Kenilworth, NJ

  Disclosure: Merck & Co., Inc.: Employee
• BW

  Brian Wynne, MD

  Director
  ViiV Healthcare
  Durham, NC

  Disclosure: GSK: Shareholder
  viiv healthcare: Employee
• CB

  Cédric Bretonnière, MD, PhD

  Dr
  Institut du Thorax - CHU Nantes
  Nantes, Pays de la Loire, France

  Disclosure: Nothing to disclose
• JK

  Jason Kim, MD, MSCE

  Director, Clinical Research- Infectious Diseases
  Merck & Co., Inc.
  Kenilworth, NJ

  Disclosure: Merck & Co., Inc.: Employee, Shareholder
• GL

  George Lewis, PhD

  Professor
  Institute of Human Virology, University of Maryland School of Medicine
  Hanover, MD

  Disclosure: Nothing to disclose
• KS

  Kimberly Smith, MD

  VP and Head, Global Research and Medical Strategy
  ViiV Healthcare
  Research Triangle Park, NC

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• MS

  Marty St. Clair

  Ms
  ViiV Healthcare
  Research Triangle Park, NC

  Disclosure: ViiV Healthcare: Employee
• MG

  Martin Gartland, PhD

  Medicine Development Lead
  ViiV Healthcare
  Research Triangle Park, NC

  Disclosure: GlaxoSmithKline: Shareholder
  ViiV Healthcare: Employee
• JP

  Jerome Pugin, MD

  Professor
  Hôpitaux Universitaire de Genève
  Geneva, Geneve, Switzerland

  Disclosure: Nothing to disclose
• MS

  Mohammad Sajadi, MD

  Associate Professor
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• BS

  Britt Stancil, BS in Statistics

  Statistics Leader
  GSK
  Fuquay Varina, NC

  Disclosure: GlaxoSmithKline: Employee
• JT

  José Trenado Álvarez, MD, PhD

  Director
  Hospital Universitari Mutua Terrassa
  Terrassa, Catalonia, Spain

  Disclosure: Nothing to disclose
• PW

  Peter Williams, Ph.D.

  Dr
  Janssen Research & Development, LLC
  Beerse, Antwerpen, Belgium

  Disclosure: Johnson & Johnson: Employee, Shareholder
• AH

  Ana Catalina Hernandez Padilla

  MD
  Centre Hospitalier Universitaire de Limoges, Limoges, France
  Limoges, Limousin, France

  Disclosure: Nothing to disclose
• WS

  William Spreen, PharmD

  R&D, Medicine Development Leader
  ViiV Healthcare
  Research Triangle Park, North Carolina

  Disclosure: ViiV Healthcare: Employee
• FC

  Frank Coenjaerts, PhD

  Dr.
  University Medical Center Utrecht
  Utrecht, Utrecht, Netherlands

  Disclosure: Nothing to disclose
• OA

  Omar Ali, Ph.D.

  Associate Director, Clinical Development Scientist
  AstraZeneca
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee, Shareholder
• KS

  Kathryn Shoemaker, MS

  Senior Principal Statistician
  AstraZeneca
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee, Shareholder
• AR

  Alexey Ruzin, PhD

  Principal Scientist
  AstraZeneca
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee, Shareholder
  Innovative Medicines Initiative (IMI): Other Financial or Material Support, IMI grant # 115523, composed of European Union 7th Framework Programme FP7/2007-2013 and EFPIA in-kind contributions
• VP

  Vadryn Pierre, PharmD

  Senior Clinical Pharmacokineticist
  Astrazeneca
  Columbia, MD

  Disclosure: Astrazeneca: Employee
• YW

  Yuling Wu, PhD

  Associate Director
  Biopharma
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee
  AstraZeneca: Employee
• SC

  Susan Colbert, RN, BSN

  Senior Clinical Program Manager
  Gaithersburg, MD

  Disclosure: Nothing to disclose
• TB

  Terramika Bellamy, MS

  Director Clinical Operations
  Gaithersburg, MD

  Disclosure: Nothing to disclose
• MM

  Michael McCarthy, MD

  Product Development Team leader
  MedImmune
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee
• FD

  Filip Dubovsky, MD, MPH

  Vice-President
  AstraZeneca
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee, Shareholder
• HJ

  Hasan Jafri, MD

  Senior Director
  AstraZeneca
  Gaithersburg, MD

  Disclosure: AstraZeneca: Employee

Moderator(s)

• SA

  Senu Apewokin, MD

  Medical Director, Transplant Infectious Diseases
  University of Cincinnati
  Mason, OH

  Disclosure: Astellas Pharma: Advisory Board
  Viracor: Material ( Assay) Support
• 

  Erica Johnson, MD

  Assistant Professor of Medicine, Division of Infectious Diseases
  Johns Hopkins
  Baltimore, MD

  Disclosure: Nothing to disclose

Presenting Author(s)

• JC

  Joel Chua, MD

  Assistant Professor
  Institute of Human Virology, University of Maryland School of Medicine
  Baltimore, MD

  Disclosure: Nothing to disclose
• BF

  Bruno Francois, Physician

  MD
  CHU Dupuytren Limoges
  Limoges, Limousin, France

  Disclosure: ASTRAZENCA: Scientific Research Study Investigator
• DM

  David Margolis, MD, MPH

  Director of HIV Drug Development
  ViiV Healthcare
  Research Triangle Park, North Carolina

  Disclosure: ViiV Healthcare: Employee, Shareholder, Other Financial or Material Support, Salary and stock options
• Jv

  Jean van Wyk, MB,ChB

  Medical Director
  ViiV Healthcare
  Brentford, England, United Kingdom

  Disclosure: GSK: Shareholder
  ViiV Healthcare: Employee
• CD

  Carisa De Anda, PharmD

  Executive Director, Clinical Research
  Merck & Co., Inc.
  Kenilworth, NJ

  Disclosure: Merck & Co., Inc.: Employee