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AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013
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AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Dec 15, 2015

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Page 1: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

AIDS Research at the NHLBI:

A Program in Evolution

NHLBI AIDS Team

June 7, 2013

Page 2: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

AIDS Research at the NHLBI

Changing Profile of AIDS

NHLBI AIDS Program

- Key Actions in 2012-13

NHLBI AIDS Program

- The Future

Page 3: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Adults and Adolescents Living with an AIDS Diagnosis, by Sex,

1993-2009 – United States and 6 U.S. Dependent Areas

Page 4: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

AIDS – An Evolving Population

AIDS Patients Face Downside of Living Longer, January 2008

The number of people 50 and older living with HIV in U.S. has increased 77% from 2001 to 2005.1

By the year 2015, HIV patients aged 50 and older will account for half of all HIV/AIDS cases in the U.S.1

Chronic disease conditions such as cardiovascular disease are an increasing important health issue in this population.

1 www.cdc.gov

Page 5: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Many Age-Associated Diseases More Common in Treated HIV Disease Than in Age-Matched Controls

Multiple factors likely explain this increased risk, including co-morbid conditions and antiretroviral drug toxicity

• Cardiovascular disease• COPD• Anemia• Liver failure• Kidney failure• Cognitive decline• Frailty• Immune system• Cancer (non-AIDS)• Bone fractures/osteopenia

Chronic inflammation may underlie many of these

conditions

Page 6: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

NHLBI Is the Third Largest NIH Institute

NIH Institute Budgets

NCI $5 B NIAID $4.7 BNHLBI $3 BNIGMS $2 BNIDDK $1.8 B

Page 7: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

National Heart, Lung, and Blood Institute

Mission:

Provide global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives.

Page 8: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Independent Budget 2013 – $64 million

Separate Payline 2013 – Comparable to Early Stage Investigator

AIDS Specific Receipt Dates

AIDS Specific Review AIDS Study Sections Clinical trials reviewed in CLTR

8

NHLBI AIDS Program: Key Facts

Page 9: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Team Mission Statement Working Group Initiatives Website Professional Meetings Key Large Projects

Key Actions in 2012-13

Page 10: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

Organized Team

Page 11: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Name NHLBI AIDS Team Role

Monica Shah, MD NHLBI AIDS Coordinator

Renee Wong, PhD CV Team Leader

Hannah Peavy, MD Lung Team Leader

Sandra Colombini-Hatch, MD Lung Team Leader

Simone Glynn, MD Blood Team Leader

Shimian Zou, PhD Blood Team Leader

Myron Waclawiw, PhD Statistics

Tony Creazzo, PhD Review

Kristin Burns, MD Pediatrics/CV Team

Anu Rao, MD CV Team

Ryan Lombardi Grants Management

Lis Caler, PhD Lung Team

NHLBI AIDS Team: Organization

Page 12: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

Developed

Mission Statement

Page 13: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

The NHLBI AIDS Program provides global leadership for research, training, and education

programs to promote the prevention and treatment of HIV-related cardiovascular, pulmonary, and hematologic disease.

The NHLBI AIDS Program believes that critical research in this area will result in discovery that enhances the survival and quality of life of patients with HIV, and may also lead

to knowledge that benefits all patients with heart, lung, and blood disease.

NHLBI AIDS Program – Mission Statement

Page 14: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

Conducted

Working Group

Page 15: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

AIDS WG: Recommendations

Scientific Gaps Approaches to GapsEpidemiology

• Incidence/prevalence of HIV-related HLB disease

• Utilize existing cohorts to examine questions about HIV-related HLB disease

• Enrich ongoing HLB studies with HIV patients

Pathophysiology

• Mechanisms of the interplay of HIV/inflammation, ART, co-infections, microbiome, and traditional risk factors in development and progression of HIV-related HLB disease

• Conduct fundamental studies that elucidate pathogenesis of HIV-related HLB

Treatment & Prevention

• Efficacy and effectiveness of evidence-based therapies in HIV patients

• Novel therapies to address unique pathophysiology of HIV-related HLB disease

• Add HLB outcomes to HIV trials to understand the effects of HIV therapies on end-organ complications

• Increase enrollment of HIV patients into HLB trials

• Collaborate with HIV trial networks early during protocol development

http://www.nhlbi.nih.gov/meetings/workshops/AIDSworking.htm

Page 16: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

AIDS WG: Recommendations

Research Strategy Themes

Approach Details

Communication • Professional HLB societies• Other Institutes

Collaboration and Teamwork • Collaborate with other IC to understand how to best leverage resources and develop new programs

• Develop inter-disciplinary investigator teams

Leveraging Resources • Utilize existing HIV cohorts and studies and enrich with HLB endpoints, increase enrollment of HIV patients into HLB trials

• Utilize infrastructure of HIV networks to develop HLB focused trials

Page 17: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

Developed New Initiatives

Page 18: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Disseminate goals of NHLBI AIDS Program Recognize NHLBI as a primary funding Institute

for AIDS research Focus on scientific gaps identified at workshop Broadly stimulate science Promote multi-disciplinary collaboration Encourage peer-review Timeline

NIH Guide Fall 2013 January 2014 receipt date

AIDS Initiatives: Guiding Principles

Page 19: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

InitiativeNumber of

AwardsNumber of Years

Total Budget

RFA (R01, R21) Basic HIV-Related HLB Research

FY1432 5 $72 million

RFA (R01) Clinical HIV-Related HLB

ResearchFY14

22 5 $67 million

RFA (U19) Beyond HAART: Innovative

Approaches to Cure HIVFY15

3 5 $28 million

Planned AIDS Initiatives

Page 20: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

Developed AIDS Website

Page 21: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

NHLBI AIDS Website

Page 22: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

NHLBI AIDS Website

Page 23: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

National Presentations

Page 24: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

2013 – Conference on Retroviruses and Opportunistic Infections

2013 – American Heart Association

2013 – American Thoracic Society

National Presentations

Page 25: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Action:

NHLBI AIDS Program

Publications and Activities

Page 26: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key AIDS Programs: Heart

Key Publications

•HIV Infection and the Risk of Acute Myocardial InfarctionFreiberg, M, JAMA Internal Medicine, 2013

HIV infection associated with 50% increased risk of AMI beyond that explained by recognized risk factors. •Arterial Inflammation in Patients with HIV Grinspoon, JAMA, 2012

Increased arterial wall inflammation by PET in HIV pts. vs. non-HIV controls with similar cardiac risk factors; associated increased markers of monocyte & macrophage activation.

http://www.hivcvd.org/

Project Officer (PO): Cheryl McDonald, MD

Page 27: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key Large AIDS Programs: Lung

Program Key Publications

Longitudinal Studies of HIV-Associated Lung Infections and Complications

PO: Hannah Peavy, MD

• Contributors to diffusion impairment in HIV-infected persons

Gingo, MR, Eur Respir J, 2013

Lung HIV Microbiome Project

PO: Sandra Colombini-Hatch, MD

• Widespread Colonization of the Lung by T. whipplei in HIV Infection

Lozupone, C, Am J Respir Crit Care Med, 2013

Program Goals

Mechanisms of HIV-Associated Lung Disease

PO: Hannah Peavy, MD

• Investigate cellular and molecular events underlying HIV-associated lung disease

• Identify disease sub-phenotypes, biomarkers to predict risk and molecular targets to design therapeutic

Page 28: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Key AIDS Programs: Blood

Program Key Study

REDS-III • South Africa Obstetric Hemorrhage and HIV

• Brazilian Sickle Cell Disease and HIV

• HIV molecular surveillance in the US, Brazil, China and South Africa

Cell Therapy

• Engraftment and in vivo selection of HIV-protected stem cells (5R01HL116217)

• Allogeneic Transplant in HIV Patients (NCT01410344; BMT CTN 0903)

Test Development

• HIV Selectest (REDS-II)

Program Key Publication

REDS-II • Genetic diversity of recently acquired and prevalent HIV infections in US blood donors

Delwart, J Infect Dis 2012.

• HIV genotypes and primary drug resistance among HIV seropositive blood donors in Brazil,

Sabino, J Acquir Immune Defic Syndr, 2013.

PO: Simone Glynn, MDShimian Zou, PhD

Page 29: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.

Increasing burden of HIV-related HLB disease

NHLBI uniquely poised to support research in this area

NHLBI AIDS Program – Long Term Plan Develop NHLBI AIDS portfolio Enhance communication and collaboration Cultivate HIV-HLB scientific community

Results Research that improves outcomes for HIV patients – and all

patients with HLB disease

NHLBI AIDS Program: The Future

Page 30: AIDS Research at the NHLBI: A Program in Evolution NHLBI AIDS Team June 7, 2013.