2015 Annual ACTG Scientific Retreat February 27-28, 2015

Size: px

Start display at page:

Download "2015 Annual ACTG Scientific Retreat February 27-28, 2015"

Stanley Peters
5 years ago
Views:

2015 Annual ACTG Scientific Retreat February 27-28, 2015 Scientific Committee Sessions Antiretroviral Therapy Strategies Subcommittee 1 End-Organ Disease/Inflammation Transformative Science Group 2

1 2015 Annual ACTG Scientific Retreat February 27-28, 2015 Scientific Committee Sessions Antiretroviral Therapy Strategies Subcommittee 1 End-Organ Disease/Inflammation Transformative Science Group 2 Hepatitis Transformative Science Group 3 HIV Reservoirs/Viral Eradication Transformative Science Group 4 Neurology Collaborative Science Group 5 Tuberculosis Transformative Science Group 6 Women s Health Inter-Network Scientific Committee 7 Community Session Community Scientific Subcommittee 8 Protocol Session REPRIEVE (A5332 and A5333s) Investigator Session 9-10 Closing/Wrap-up Session 11

2 ANTIRETROVIRAL THERAPY STRATEGIES SUBCOMMITTEE (ARTS) SESSION Friday, February 27, 2015, 12:00 p.m. 2:00 p.m. Chair: Babafemi Taiwo, MBBS, MD Northwestern University CRS Vice Chair: Raphael Landovitz, MD University of California, Los Angeles CARE Center CRS 1. Welcome and Introductions Babafemi Taiwo, MBBS, MD Raphael Landovitz, MD 2. CROI 2015 Summary and Ideas for ACTG Studies Raphael Landovitz, MD 3. Long Acting (LA) Therapy Workshop Summary Charles Flexner, MD 4. Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study (PADDLE) 5. Potential Two-Drug Antiretroviral Therapy and LA Agents Studies Pedro Cahn, MD Babafemi Taiwo, MBBS, MD 6. Discussion Break All Members 7. Community Discussion Moses Nsubuga 8. General Discussion All Members -1-

3 END-ORGAN DISEASE/INFLAMMATION TRANSFORMATIVE SCIENCE GROUP (ITSG) SESSION Friday, February 27, 2015, 2:00 p.m. 5:00 p.m. Chair: Peter Hunt, MD University of California, San Francisco HIV/AIDS CRS Vice Chair: Turner Overton, MD Alabama CRS Welcome and Introductions Peter Hunt, MD Turner Overton, MD 2:00 Key ITSG-related Data from the Conference on Retroviruses and Opportunistic Infections (30 minutes per topic) a. Bone Disease/Frailty/Metabolic Disease (2:00-2:30) b. Neurology (2:30-3:00) c. Cardiovascular/Pulmonary Disease (3:00-3:30) d. Pathogenesis (3:30-4:00) e. Immune-based Interventions (4:00-4:30) Todd Brown, MD, PhD Todd Hulgan, MD, MPH David Clifford, MD Giovanni Schifitto, MD Kristina Crothers, MD Carl Fichtenbaum, MD Nicholas Funderburg, PhD Nichole Klatt, PhD Jordan Lake, MD, MSc Netanya Sandler Utay, MD 4:30 Closing Discussion/Brainstorming All Participants -2-

4 HEPATITIS TRANSFORMATIVE SCIENCE GROUP (HEP TSG) SESSION Friday, February 27, 2015, 12:00 p.m. 3:00 p.m. Chair: Raymond Chung, MD Massachusetts General Hospital CRS Vice Chair: Mark Sulkowski, MD Johns Hopkins University CRS 12:00 Welcome and Update on the HEP TSG Scientific Agenda Raymond Chung, MD Mark Sulkowski, MD 12:10 Adaptive Immunologic Inhibitors Shyam Kottilil, MD, PhD 12:40 Virology Life Cycle-Clinical Trial Design Ramifications 1:10 Science of HIV Cure: Lessons to be Translated to HBV Marion Peters, MD Joseph Eron, MD Rajesh Gandhi, MD 1:40 Roundtable Discussion HEP TSG Members -3-

5 HIV RESERVOIRS AND VIRAL ERADICATION TRANSFORMATIVE SCIENCE GROUP (CURE TSG) SESSION Friday, February 27, 2015, 9:00 a.m. 1:00 p.m. Chair: Vice Chair: Joseph Eron, MD University of North Carolina Global HIV Prevention and Treatment CTU Rajesh Gandhi, MD Massachusetts General Hospital CRS 9:00 Welcome Joseph Eron, MD 9:05 Treatment with a TLR7 Agonist Induces Transient Viremia in SIV-Infected ART- Suppressed Monkeys James Whitney, PhD 9:35 Role of HIV Integration in HIV Persistence Frank Maldarelli, MD, PhD 10:05 Open Discussion All Attendees 10:30 Break 10:45 Implications of CROI Presentations (20 minutes per topic) a. Lessons Learnt From the SPARTAC Study Towards Understanding Post Treatment Viral Control (10:45) b. The Size of the Active HIV Reservoir Predicts Timing of Viral Rebound (11:05) c. HIV-1 Diversity and Tropism of Rebound Virus after Treatment Discontinuation (11:25) 11:45 Mathematical Modeling as a Tool in HIV Reservoirs and Eradication Research 12:15 Open Discussion: Cure TSG Future Directions for Next Six Months and Potential New Proposals Sarah Fidler, MD Jonathan Li, MD Ronald Swanstrom, PhD Maria Bednar, PhD Alan Perelson, PhD All Attendees -4-

6 NEUROLOGY COLLABORATIVE SCIENCE GROUP Friday, February 27, 2015, 7:00 a.m. 9:00 a.m. Chair: Serena Spudich, MD Weill Cornell Chelsea CRS/Yale University School of Medicine Vice Chair: Scott Letendre, MD University of California, San Diego AntiViral Research Center CRS 1. Welcome and Introductions Neurology Collaborative Science Group Chairs 2. Key Questions in NeuroAIDS Research in the United Kingdom and Beyond Alan Winston, MD 3. CROI 2015 Neurology-Related Highlights David Clifford, MD Felicia Chow, MD 4. Randomized Clinical Trial for Prevention of HAND in China Scott Letendre, MD 5. Active Protocol Team presentations a. A5324 (ART intensification for HAND) b. A5321 (ACTG HIV Reservoirs Cohort)/ A5341s (A5321 Sampling Substudy) c. SPIRIT Study Kevin Robertson, MD Raj Gandhi, MD Deborah McMahon, MD Beau Ances, MD -5-

7 TUBERCULOSIS TRANSFORMATIVE SCIENCE GROUP (TB TSG) SESSION Friday, February 27, 2015, 2:00 p.m. 5:00 p.m. Chair: Richard Chaisson, MD Johns Hopkins University CRS Co-Vice Chairs: Gavin Churchyard, MBBCh, MMed, FCP, PhD The Aurum Institute for Health Research Diane Havlir, MD San Francisco Bay CTU 2:00 Update from CROI on Topics Relevant to the TB TSG Agenda 2:20 What do 2-month and Other Surrogate Outcomes Mean for Treatment Shortening? Francesca Conradie, MD, DTM&H Payam Nahid, MD Patrick Phillips, PhD 3:15 Lessons from the QT Front Kelly Dooley, MD, PhD Gary Maartens, MBBCh, MMed 3:35 Delamanid Updates Lawrence Geiter, PhD 4:00 Linezolid Study Proposal Constance Benson, MD 4:30 Update on A5300/P2003 (Phoenix MDR TB Study) Gavin Churchyard, MBBCh, MMed 4:50 Discussion and Wrap-up Richard Chaisson, MD -6-

8 WOMEN S HEALTH INTER-NETWORK SCIENTIFIC COMMITTEE (WHISC) SESSION Friday, February 27, 2015, 9:00 a.m. 11:00 a.m. Chair: Cynthia Firnhaber, MD Wits HIV CRS Vice Chair: Elizabeth Connick, MD University of Colorado Hospital CRS 1. Welcome and Introductions Cindy Firnhaber, MD 2. Review of Relevant Data at CROI and Potential Studies a. Cure/Inflammation b. Hormonal Contraception c. Neurology and Mental Health Issues d. HPV e. Women and Antiretrovirals f. Tuberculosis/Hepatitis/Other Infections Cindy Firnhaber, MD, Moderator Elizabeth Connick, MD Adriana Weinberg, MD Danielle Campbell, MPH Timothy Wilkin, MD, MPH Anandi Sheth, MD Cindy Firnhaber, MD Susan Cohn, MD, MPH Adriana Weinberg, MD 3. Women s Health Agenda Future Areas of Research All Participants -7-

9 COMMUNITY SCIENTIFIC SUBCOMMITTEE (CSS) BUSINESS SESSION Saturday, February 27, 2015, 1:00-4:00 p.m. Session Chairs: Liz Barr, CSS ACTG Executive Committee and Scientific Agenda Steering Committee Representative Royce Hardin, CSS ACTG Executive Committee and Performance Evaluation Committee Representative Chapel Hill CRS 1. Reports from CSS Members Who Attended CROI: How might Information from CROI Help Shape the Scientific Agenda? 2. How can Community Contribute to New Works Concept Sheets and Data Analysis Concept Sheets Possibility of Developing a Community DACS? CSS CROI Attendees All Members 3. Urgent Matters from Scientific Retreat All Members 4. How to Improve Participation of CSS Members All Members -8-

10 REPRIEVE (A5332) AND THE MECHANISTIC SUBSTUDY OF REPRIEVE (A5333S) INVESTIGATOR SESSION Friday, February 27, 2015, 7:00 a.m. 9:00 a.m. Principal Investigators: Steven Grinspoon, MD Harvard Medical School/Massachusetts General Hospital Pamela Douglas, MD Duke Clinical Research Institute Udo Hoffmann, MD, MPH Harvard Medical School/Massachusetts General Hospital Heather Ribaudo, PhD ACTG Statistical and Data Analysis Center ACTG Investigators: Turner Overton, MD Alabama CRS Carl Fichtenbaum, MD University of Cincinnati CRS Judith Aberg, MD Columbia Physicians & Surgeons CRS/Mt. Sinai CRS Markella Zanni, MD Massachusetts General Hospital CRS 1. Welcome and Introductions REPRIEVE Progress to Date Steven Grinspoon, MD 2. Welcome from the National Institutes of Health Sarah Read, MD Monica R. Shah, MD 3. ACTG Leadership Update Daniel Kuritzkes, MD 4. A5332 and A5333s Brief Protocol Summary Protocol Related Frequently Asked Questions 5. Timelines and Study Requirements Site Approval, Protocol Activation and Registration Site Performance Evaluation Turner Overton, MD Carl Fichtenbaum, MD -9-

11 6. Endpoint Reporting (MACE and non-mace Events) Description of Adjudication Process Mechanistic Substudy Incidental Findings 7. What s New in REPRIEVE Data Capture OpenClinica CDISC Source Documents Timing of Synthesis for DSMB Review 8. Revised DAIDS Toxicity Table AE Reporting (A5332 and A5333s) Monitoring 9. Ancillary Studies Approved for Development Coenrollment of ACTG Studies Markella Zanni, MD Heather Ribaudo, PhD Karin L. Klingman, MD Turner Overton, MD 10. Question and Answer Team -10-

12 CLOSING/WRAP-UP SESSION Saturday, February 28, 2015, 9:00 a.m. 12:00 p.m. Chair: Daniel Kuritzkes, MD ACTG Network Chair Vice Chairs: Judith Currier, MD, MSc ACTG Network Vice Chair Ian Sanne, MBBCH, FTP (SA) ACTG Network International Vice Chair 9:00 Presentations from Transformative Science Group Sessions (Approximately 10 minutes presentation each and 15 minutes discussion each) a. Tuberculosis (9:00-9:25) b. HIV Reservoirs/Viral Eradication (9:25-9:50) c. Hepatitis (9:50-10:15) d. End-Organ Disease/Inflammation (10:15-10:40) Richard Chaisson, MD Joseph Eron, MD Raymond Chung, MD Peter Hunt, MD 10:45 Presentation from Other Committee Sessions (Approximately 5 minutes presentation each and 5 minutes discussion each) a. Women s Health Inter-network Scientific Committee (10:45-10:55) b. Neurology Collaborative Science Group (10:55-11:05) c. Antiretroviral Therapy Strategies Subcommittee (11:05-11:15) Cynthia Firnhaber, MD Serena Spudich, MD Babafemi Taiwo, MBBS, MD 11:20 Overall Scientific Agenda Discussion and Planning Judith Currier, MD, MSc Daniel Kuritzkes, MD Ian Sanne, MBBCH, FTP -11-

2016 Annual ACTG Scientific Retreat February 26-27, 2016

2016 Annual ACTG Scientific Retreat February 26-27, 2016 Scientific Committee Sessions Antiretroviral Therapy Strategies Subcommittee... 1 End-Organ Disease/Inflammation Transformative Science Group...