The National Institute of Allergy and Infectious Diseases, Division of AIDS (NIAID/DAIDS), in partnership with the Forum for Collaborative Research organized the “Framework for Initiating Pediatric Studies of HIV Cure Interventions: Scientific knowledge gaps, regulatory and ethical considerations” workshop. This workshop, held May 22-23, 2018, in Rockville, Maryland, discussed regulatory pathway strategies for moving promising HIV cure products into pediatric trials. 

The workshop brought together investigators in the field of HIV persistence, academics, industry and product developers, ethicists, regulators and community advocates to discuss requirements for prioritizing and accelerating investigation of these products safely and ethically children living with HIV. 

The 1st International NASH Day brings together the largest coalition of stakeholders to fight against NASH

Washington, D.C., Tuesday, June 12, 2018 - The Forum for Collaborative Research is proud to support the first International NASH Day taking place today, June 12, 2018. This is a groundbreaking event organized by the NASH Education Program™ and its benefactors and supporters around the world. Over 20 international organizations have joined the coalition, and 150 key opinion leaders in the field have signed onto a Global Call-to-Action. The Liver Forum was also honored to participate in a congressional briefing coordinated by the NASH Education Program™ that occurred yesterday, June 11, to launch International NASH Day on Capitol Hill.

There has been an increase in HIV cure-related research in the recent years. Many approaches are being investigated in the United States and other countries.

We would like to find out what people living with HIV in the United States who might one day decide to join a study think about HIV cure research, including their willingness to participate in HIV cure studies. By HIV cure studies, we mean those that involve collecting blood or tissue or even trying new types of drugs and therapies as a first step toward a cure. In particular, we are interested in how people view the potential risks and benefits of different kinds of strategies (a strategy might involve taking different combinations of pills and injections for several weeks and then seeing what happens) and how they view these strategies compared to current HIV medications.

The Obesity and Fat Metabolism in HIV-infected Individuals workshop took place at the National Institutes of Health in Rockville, MD on May 22 and 23, 2018. 

Materials

     Agenda

Presentations 

Welcome and Opening Remarks

Griffin Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases

Catherine Godfrey, National Institute of Allergy and Infectious Diseases

Andrew Bremer, National Institute of Diabetes and Digestive and Kidney Diseases

Session I: Overview- Setting the Stage

Chair: Peter Hunt, University of California, San Franscisco

Session Overview:

• Brown vs beige fat: generalized obesity vs dysfunctional adipose tissue
• lifespan issues

• Overview of the underlying biology of immune system activation linking it to obesity

          Clovis Palmer, Burnet Institute

• Epigenetic link - in utero issues

         Mary-Elizabeth Patti, Joslin Diabetes Center

• Fat types, distribution, sex differences, age differences, racial and ethnic differences

          Aaron Cypess, National Institute of Diabetes and Digestive and Kidney Diseases

Session II: It's the Virus!

Co-Chairs: Todd Brown, Johns Hopkins University

Roger Paredes, IrsiCaixa AIDS Research Institute

Session Overview:

• Relationship between HIV and its viral products and fat 

• HIV viral products and the immunometabolism

          Dorothy Lewis, The University of Texas Health Science Center at Houston

• miRNA, dicer and adipose tissue in HIV: novel pathways of fat regulation and organ specific cross-talk in HIV

          Steve Grinspoon, Massachusetts General Hospital

• Fat and HIV persistence, role of fat metabolism and inflammation

           Marta Giralt, University of Barcelona

Session III: Immune and Metabolic Interactions

Co-Chairs: Steve Grinspoon, Massachusetts General Hospital

Jason Baker, University of Minnesota

Session Overview:

• What WBCs are in fat? (M1, M2, Tregs, T effectors, NK cells, innate immune lymphocytes, and possibly even B-cells)
• the adipocyte as a monocyte origin cell
• Adipose tissue function, dysfunction, and fat fibrosis. What does this all mean?

            Suneil Koliwad, University of California San Francisco

• Fat as an immunologically active tissue: Defining the scope and cell types

           Alyssa Hasty, Vanderbilt University School of Medicine

• Role of leptin and other adipokines in HIV infection and HIV-related obesity

          John Koethe, Vanderbilt University

Session IV: GI Tract and Adipocyte Interactions

Co-Chairs: Rohit Loomba, University of California, San Diego

Netanya Utay, University of Texas Houston

Session Overview: 

• The interplay between HIV and the GI tract, adipose tissue, and the liver
• Other microbial "players" involved in mediating interactions between HIV and tissues

• GI tract barrier breakdown and adipocyte inflammation

          Janet Lo, Massachusetts General Hospital

• Microbiome and products of microbial metabolism

          Ivan Vujkovic -Cvijin, National Institute of Allergy and Infectious Diseases

• Liver disease/fatty liver, function of total fat, dysfunctional adipose tissue, and a depot that can't handle it.... Difference between HIV and non-HIV 

          Colleen Hadigan, National Institute of Allergy and Infectious Diseases

Session V: Pharmacology and Treatment of Obesity

Session Overview:

• Non-viral effects of current HIV therapy 
• Viral and non-viral considerations for future HIV therapies

• ART effect on fat quantity and quality

           Grace McComsey, University Hospitals Health System and Case Western Reserve University

• Metformin

          Alex Soukas, Center for Genomic Medicine

• Other treatment options in the pipeline

          Steven Heymsfield, Pennington Biomedical Research Center

Session VI: How do we translate this information to the clinic? What clinical trials are needed? What tools are needed?

Co-Chairs: Judith Currier, University of California, Los Angeles

                  Grace Aldrovandi, University of California, Los Angeles

Session Overview:

• Moving the science forward
• What clinical trials are needed?
• What tools are needed?

• Measuring endpoints and outcomes

Caroline Apovian, Boston University School of Medicine

• What clinical trials are needed?

Turner Overton, University of Alabama School of Medicine

This workshop was sponsored by:

National Institute of Allergy and Infectious Diseases

National Institute of Diabetes and Digestive and Kidney Diseases

National Institues of Health Office of AIDS Research

National Instiutes of Health Office of Research on Women's Health

Washington DC, Thursday, May 31, 2018– The Forum for Collaborative Research is excited to announce a new partnership with the Center for Medical Technology Policy’s (CMTP) Green Park Collaborative (GPC) and the Obesity Action Coalition (OAC) to develop a core set of outcomes for non-alcoholic steatohepatitis (NASH). This initiative, coreNASH, will be conducted as a multi-stakeholder collaboration, including patients, clinicians, payers, HTAs, regulators, and industry organizations, that will help set how outcomes in NASH clinical trials should be measured.

In the final days of National Minority Health Month, we want to highlight disparities in the health status of racial and ethnic minority populations in the United States and share opportunities to address the disparities in viral hepatitis. The theme for 2018 is “Partnering for Health Equity,” which highlights partnerships at the federal, state, local, tribal and territorial levels that help reduce disparities in health and health care. This year’s focus on partnerships is a great way to advance one of the goals of the National Viral Hepatitis Action Plan (Action Plan)—reducing hepatitis B and C health disparities— which can be achieved by bringing together a broad group of stakeholders like you.

The U.S. Department of Agriculture is making grants available for projects building local responses to opioid misuse in rural communities through its Community Facilities Grant Program and Distance Learning and Telemedicine Grant Program. Projects with the primary purpose of providing opioid prevention, treatment or recovery services will receive priority. The application deadline for both programs is June 4, 2018.  More information on the grants and how to apply is available on the USDA website.

The U.S. Centers for Disease Control and Prevention has released guidance to assist communities in planning for outbreaks of HIV or hepatitis C virus among people who inject drugs, with an emphasis on developing response plans that avert further transmissions.