NIAID Funding Opportunities in HIV/AIDS Research Karl Salzwedel Division of AIDS, NIAID, NIH July 2, 2013.

NIAID Funding Opportunities in HIV/AIDS

ResearchKarl Salzwedel

Division of AIDS, NIAID, NIH

July 2, 2013

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately

prevent infectious, immunologic, and allergic diseases.

The Division of AIDS (DAIDS)

Scientific Programs

• Basic Sciences Program• Therapeutics Research Program• Prevention Sciences Program• Vaccine Research Program

Steps Along the HIV Cure Pathway

Basic Research

Translational Research

Pilot Clinical Studies

Phase I-IV

Clinical Trials

Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01)

Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

Beyond HAART:  Innovative Therapies to Control HIV-1 (P01)

Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33)

Clinical Trials Networks: Cure Agenda (UM1)

FY11

FY14

FY13

FY12

FY14

Basic Research

Translational Research

Pilot Clinical Studies

Phase I-IV

Clinical Trials

Targeting Latently Infected Cells Without Reactivation (R01)

Beyond HAART II Innovative Therapies to Control HIV (U19)

Pilot Clinical Trials to Eliminate the Latent

Reservoir (U01)

Quantitative Viral Outgrowth Assay (Q-VOA) Service Resource (N01)

Innovative Assays to Quantify the Latent HIV Reservoir (R21, R01)

Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01)

Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

Beyond HAART:  Innovative Therapies to Control HIV-1 (P01)

Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33)

Clinical Trials Networks: Cure Agenda (UM1)

New

New

NewNew

New

New Funding Initiatives for 2015

NIH AIDS Reagent Program

• Viruses• Cell lines, hybridomas• Monoclonal and polyclonal antibodies• DNA clones, DNA libraries, expression vectors • Recombinant proteins, synthetic peptides• Reference panels for:

– PCR– HIV subtyping– Drug resistant viruses– Neutralizing antibodies and sera

• Antiviral drug standards

http://www.aidsreagents.org

Provides standardized reagents and new technologies to the AIDS research community

U.S. institutions with funding to provide shared infrastructure support for HIV research

CFARs support a multidisciplinary, collaborative environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS.

Web site: www.niaid.nih.gov/LabsAndResources/resources/cfar

CFAROne mission of the CFAR is to strengthen capacity for HIV/AIDS research in developing countries.

CFARs accomplish this through a variety of ways including:

• Establishment of Cores abroad which provide training, services and expertise to local investigators

• Provide funding for pilot projects with an international component through the CFAR Developmental Core

• Offer training/mentorship in-country or in US

• Access to databases, repositories, computer-based training

CFARs are a Trans-NIH Program

Co-funded by nine NIH Institutes:

National Institute of Allergy and Infectious Diseases (NIAID)National Cancer Institute (NCI)National Institute of Child Health and Human Development (NICHD)National Heart, Lung and Blood Institute (NHLBI)National Institute on Drug Abuse (NIDA)National Institute on Mental Health (NIMH)National Institute on Aging (NIA)National Institute of General Medical Sciences (NIGMS)National Institute of Nursing Research (NINR)

Co-managed by the NIH Institutes above, and by:

Office of AIDS Research (OAR)Fogarty International Center (FIC)

CENTERS FOR AIDS RESEARCH

CFAR projects funded 2009-2012

India (5)

China (4)

Peru (3)

Brazil (1)

Tanzania (11)

South Africa (20)

Zambia (5)

CFAR-Funded International HIV/AIDS Research

Malawi (8)

Kenya (26)

Cameroon (1)

Uganda (12)

Botswana (10)

Mexico (4)

Updated June 2012

Cambodia (1)

Zimbabwe (2)

Mozambique (4)

Namibia (2)

Rwanda (4)

Russia (1)

Canada (1)

Democratic Republic of Congo (1)

Ethiopia (1)Ghana (2)

Guatemala (1)

Haiti (1)

Romania (1)

Australia (2)

www.cnihr.org

Creative and Novel Ideas in HIV Research (CNIHR)Encouraging Innovation in HIV Research

Goal: to attract both international and U.S.-based early stage investigators from outside the field of HIV research

Up to 2 yrs, $150k per year Direct Costs

Concept sheets (2 pages) will be submitted by October 16, 2013

These are U01, collaborative grants, which establish international

regional centersFoster collaboration on HIV research on

regional and global levelAdvance methodology for collection

and harmonization of dataAddress research questions using data

sets

Region 1: North America

Region 2: Latin America & Caribbean (CCASAnet)

Region 5: Australia, China, India, Pakistan, Asia (excluding Central Asia)

Region 10: East AfricaRegion 11: South AfricaRegion 9: Central AfricaRegion 8: West Africa

7 Funded Regions

International Research in Infectious Diseases including AIDS (IRIDA) Program (R01)

Objective: to advance the development of local scientific expertise, build local research infrastructure, and to increase collaborative research partnerships at

resource limited eligible foreign countries that propose research related to infectious diseases that are of interest to that country

Application Receipt Date for AIDS Applications:August 23, 2013

Contact (for HIV/AIDS Research):

Opendra Sharma, Ph.D.Telephone: (301) 496-9041

Email: [email protected]

http://grants.nih.gov/grants/guide/pa-files/PAR-11-145.html

PAR-11-145

In Summary

There are many opportunities − researching the best fit for what you wish to do is critical.

Karl Salzwedel, [email protected] Diana Finzi, [email protected] Ann Namkung Lee, [email protected]

National Institute of Mental HealthDivision of AIDS Research

Research PrioritiesDianne Rausch, Ph.D.

NIH Grantsmanship WorkshopInternational AIDS Society Meeting

Kuala Lumpur, MalaysiaJuly 2, 2013

NIMH RESEARCH AREAS

Behavioral Science

Develop, test, and implement interventions to prevent the spread of

HIV infection through behavior change and

improve health outcomes

Basic Neuroscience

Identify mechanisms underlying HIV-induced

CNS dysfunction, and develop therapeutic

strategies to prevent and treat them

HIV Behavioral Science: Research Priorities

Combination prevention interventions Feasible and cost-effective interventions “Test and Treat” research questions Prevention among MSM Behavioral aspects of biomedical tools Implementation science, especially in

collaboration with existing platforms (e.g., CDC services, PEPFAR sites)

HIV Basic Neuroscience: Research Priorities

• Biomarkers linked with mechanisms of neuropathogenesis

• Impact of aging and co-morbidities on HIV/CNS disease

• Role of global clade diversity and host genetic factors

• Develop novel therapeutics targeting HIV

neuropathogenesis

• New approaches for eradication of HIV/CNS reservoirs

• Moving NeuroAIDS therapies to the clinic

NIMH AIDS RESEARCH INITIATIVES

RFA: Pathophysiology of HIV-Associated Neuro-degeneration in Aging Populations on Long-Term ART

RFA: Eradication of HIV-1 from CNS Reservoirs

PAR: Novel NeuroAIDS Therapeutics RFA: Behavioral Mechanisms in Biomedical Strategies to Prevent HIV

Infections

RFA: Reinvigorating HIV Prevention for Men who have Sex with Men

RFA: Advancing Community-level Approaches to Reduce HIV

RFA: Promoting Engagement in Care and Timely ART Initiation

RFA: Assessing the Role of Stigma in HIV Prevention and Care

National Cancer Institute HIV/AIDS Cancer

Programs

Mostafa Nokta, MD Ph.D.

Director, AIDS Cancer Clinical Program

Office of HIV and AIDS Malignancy

National Cancer Institute

IAS Kuala Lumpur, July 2, 2013

Nati

onal

Can

cer I

nstit

ute

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

HIV/AIDS Research in the NCI

• The NCI conducts substantial extramural and intramural research programs focused on HIV-associated malignancies.

• These programs include epidemiology, basic science, translational science, and clinical research.

• The NCI is currently expanding the international focus of these efforts.

• The NCI also conducts intramural research on HIV infection.

Cancers in HIV Disease

AIDS-Defining Virus Kaposi’s Sarcoma HHV-8 Non-Hodgkin’s Lymphoma EBV, HHV-8

(systemic and CNS) Invasive Cervical Carcinoma HPVNon-AIDS Defining Anal Cancer HPV Hodgkin’s Disease EBV Lung Leiomyosarcoma (pediatric) EBV Hepatoma HBV, HCV

Non-AIDS Defining Cancers that are Increased in People with AIDS

Cancer SIR 95% CIAnus 19.6 (14.2-79.9)Hodgkin's lymphoma 13.6 (10.6-17.1)Penis 8.0 (2.2-20.6)Other/unknown site 3.4 (2.5-4.4)Liver 3.3 (2.0-5.1)Larynx 2.7 (1.6-4.4)Lung 2.6 (2.1-3.1)Myeloma 2.2 (1.1-3.9)Myeloid and monocytic leukemia 2.2 (1.1-4.0)Oral cavity and pharynx 2.1 (1.4-3.0)Renal cell carcinoma 1.9 (1.1-3.2)Kidney and renal pelvis 1.8 (1.1-2.8)All non-AIDS asociated cancers 1.7 (1.6-1.9)

- United States, 1996-2002

Source: Engles et al., AIDS, 2006, 20, 1645-54

AIDS Malignancy Consortium (AMC)

Evaluate clinical interventions for the treatment and prevention of malignancies in people with HIV

Investigate the biology of these malignancies in the context of clinical trials

Conduct Phase I, II and III clinical trials Address issues of international importance in HIV

associated malignancies Contribute specimens and clinical data to the

ACSR

AMC Clinical Sites

Core sitesAffiliated sites

AMC International Sites

Kampala, UgandaEldoret, Kenya

Lilongwe, MalawiHarare, Zimbabwe

Johannesburg South Africa

Abuja, Nigeria

MumbaiChennai

Sao Paolo, Brazil

Core SitesCollaborative Sites

AMC International Objectives

Assist with capacity building in developing nations for HIV-related cancers

Develop AMC-sponsored and co-sponsored collaborative studies with emphasis on trials that:

- Employ hypothesis-driven, scientifically sound, locally relevant and feasible therapies

- Address important pathogenesis-based questions - Utilize the unique scientific expertise of the AMC

Susan Krown, MD , [email protected] Nokta, MD, PhD, [email protected]

AIDS and Cancer Specimen Resource

• Provide high-quality HIV-associated malignancy specimens to qualified investigators at little or no cost.• Types of specimens: Frozen tissues, PBMCs, plasma, body fluids (e.g., saliva, urine, CSF), formalin-fixed tissues.• Special Collections: TMAs (NHL, KS) AMC studies, WIHS Study,HIV multi-site autopsies, international collections.

AIDS-related lymphoma, one of the tumors used to make the tissue microarray (TMA) shown in the insert.

ACSR Collaborations

• Aim : compare and contrast the genomic alterations of tumors in HIV+ patients and in HIV- patients.

• Present list of tumors included– DLCBL– BL– Lung Cancer– Anal/Cervical Cancer– Hepatocellular carcinoma (HCC)

The HIV+ Tumor Molecular Characterization Project (HTMCP):

Sites of Research Training Awards in HIV-Associated Malignancies

Zambia

South Africa

Uganda (2)

KenyaRwanda

Cameroon

Nigeria

Tanzania

• Nigeria/UM: Clinical trials, cancer epidemiology and cancer registration

• Rwanda/Einstein: Clinical research of HPV and AIDS-associated malignancies

• Tanzania/Duke: Clinical and laboratory research methodology, pathology and radiology in HIV-associated malignancies

• Uganda/UW: Clinical trials and cancer epidemiology of HIV-associated malignancies

• Uganda/UCSF: Kaposi’s sarcoma epidemiology, early detection and clinical intervention

• South Africa/Columbia: Clinical studies of Kaposi sarcoma, non-Hodgkin lymphoma and cervical cancer

• Cameroon/NYU: Basic laboratory research in HIV/AIDS cancers

• Zambia/UA: Prevention and treatment of cervical cancer

• Kenya/West Virginia: Clinical studies of HIIV-related malignancies Geraldina Dominguez, PhD

[email protected]

Comprehensive Cancer Centers

Cancer Centers

Planning Centers

Cancer Centers

Dr. Hasnaa [email protected]

NCI Partnerships in Trans-NIH AIDS Initiatives

• NIAID Led– Centers for AIDS Research (CFAR)

• Inter-CFAR HIV/AIDS Related Malignancy Working Group (iCHARM) and additional supplements linking Cancer Centers and CFARs FY2008-2012

– Women’s Interagency HIV Study (WIHS)• Cervical disease and progression• AIDS-malignancy tracking within cohort

– Multicenter AIDS Cohort Study (MACS)• Anal disease and progression and • Study of biomarkers for AIDS-related lymphoma risk

– International epidemiological Databases to Evaluate AIDS (IeDEA)• Tracking of AIDS-related malignancies

• FIC Led– AIDS International Training and Research Program (AITRP)

• Additional supplements FY2008-2012

CFAR Map

Dr. Geraldina [email protected]

Funding Opportunities (Cont.)

• Cancer Prevention Research Small Grant Program (R03) http://grants.nih.gov/grants/guide/pa-files/PAR-11-079.html

• Current and Recent Program Announcements (PAs)http://deais.nci.nih.gov/Public/RFA-PA.jsp?nt=P

NIH/NCI Sponsored Training Programs

• Short Term Exchange Program, CGH/NCI Visiting Fellows & Visiting Scientists train with

Intramural and NCI-supported Extramural Scientists

http://www.cancer.gov/aboutnci/globalhealth/programs-activities/stsep

LMI Countries

Dr. Ben Prickril, [email protected]

• NCI Summer Curriculum in Cancer Preventionhttps://cpfp.cancer.gov/summer/summer.php

Registration open November 15, 2013

All Countries

http://oham.cancer.gov

International Clinical Trials Portalwww.cancer.gov/clinicaltrials/international

• Web-based “tool box” for international cancer researchers

• Focus on collaboration between NCI and investigators outside the U.S.

More Information can be found at: http://oham.cancer.gov/

November 12-13, 2013 Lister Hill Center Auditorium

National Institutes of Health in Bethesda, Maryland

Presented by the Office of HIV and AIDS Malignancy (OHAM) National Cancer Institute

Topics will include viral oncology, immunology, genetics, epidemiology, pathogenesis, early diagnosis, and clinical

investigation of malignant diseases associated with HIV and other acquired immunodeficiency states.

ABSTRACT DEALINE is AUGUST 31, 2013

14th International Conference on Malignancies in AIDS and Other Acquired Immunodeficiencies (ICMAOI)