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AIDS Research at the NHLBI
Changing Profile of AIDS
NHLBI AIDS Program
- Key Actions in 2012-13
NHLBI AIDS Program
- The Future
Adults and Adolescents Living with an AIDS Diagnosis, by Sex,
1993-2009 – United States and 6 U.S. Dependent Areas
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
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
NHLBI Is the Third Largest NIH Institute
NIH Institute Budgets
NCI $5 B NIAID $4.7 BNHLBI $3 BNIGMS $2 BNIDDK $1.8 B
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.
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
Team Mission Statement Working Group Initiatives Website Professional Meetings Key Large Projects
Key Actions in 2012-13
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
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
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
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
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
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
2013 – Conference on Retroviruses and Opportunistic Infections
2013 – American Heart Association
2013 – American Thoracic Society
National Presentations
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
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
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
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