NIAID Funding Opportunities in HIV/AIDS Research

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

2. NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

3. The Division of AIDS (DAIDS) Scientific Programs Basic Sciences Program Therapeutics Research Program Prevention Sciences Program Vaccine Research Program

4. Steps Along the HIV Cure Pathway Clinical Trials Networks: Cure Agenda (UM1) FY14 FY12 Beyond HAART:  Innovative Therapies to Control HIV-1 (P01) Delivering Therapeutics to Residual ActiveHIV Reservoirs RFA (R01) FY14 Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33) FY13 FY11 Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

5. New Funding Initiatives for 2015 Clinical Trials Networks: Cure Agenda (UM1) Pilot Clinical Trials to Eliminate the Latent Reservoir (U01) New New Beyond HAART II Innovative Therapies to Control HIV (U19) Beyond HAART:  Innovative Therapies to Control HIV-1 (P01) Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01) Quantitative Viral Outgrowth Assay (Q-VOA) Service Resource (N01) New Targeting Latently Infected Cells Without Reactivation (R01) New Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33) Innovative Assays to Quantify the Latent HIV Reservoir (R21, R01) New Martin Delaney Collaboratory:  Towards an HIV-1 Cure (U19)

6. NIH AIDS Reagent Program Provides standardized reagents and new technologies to the AIDS research community • 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

7. 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

8. CFAR • One 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

9. 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)

10. CENTERS FOR AIDS RESEARCH

11. CFAR-Funded International HIV/AIDS Research India (5) Romania (1) Russia (1) Canada (1) China (4) Cambodia (1) Democratic Republic of Congo (1) Haiti (1) Ethiopia (1) Mexico (4) Uganda (12) Ghana (2) Kenya (26) Guatemala (1) Rwanda (4) Tanzania (11) Cameroon (1) Mozambique (4) Peru (3) Zambia (5) Zimbabwe (2) Namibia (2) Brazil (1) Malawi (8) Australia (2) Botswana (10) South Africa (20) CFAR projects funded 2009-2012 Updated June 2012

12. 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 www.cnihr.org

13. These are U01, collaborative grants, which establishinternational regional centers • Foster collaboration on HIV research on regional and global level • Advance methodology for collection and harmonization of data • Address research questions using data sets

14. 7 Funded Regions Region 1: North America Region 5: Australia, China, India, Pakistan, Asia (excluding Central Asia) Region 2: Latin America & Caribbean (CCASAnet) Region 8: West Africa Region 9: Central Africa Region 11: South Africa Region 10: East Africa

15. International Research in Infectious Diseases including AIDS (IRIDA) Program (R01) PAR-11-145 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): OpendraSharma, Ph.D. Telephone: (301) 496-9041 Email: osharma@niaid.nih.gov http://grants.nih.gov/grants/guide/pa-files/PAR-11-145.html

16. In Summary There are many opportunities − researching the best fit for what you wish to do is critical. • Karl Salzwedel, salzwedelkd@niaid.nih.gov • Diana Finzi, dfinzi@niaid.nih.gov • Ann Namkung Lee,anamkung@niaid.nih.gov

18. National Institute of Mental HealthDivision of AIDS ResearchResearch Priorities Dianne Rausch, Ph.D. NIH Grantsmanship WorkshopInternational AIDS Society Meeting Kuala Lumpur, MalaysiaJuly 2, 2013

19. NIMH RESEARCH AREAS

20. 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)

21. 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

22. 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 NeuroAIDSTherapeutics • 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

24. National Cancer Institute 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 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health

25. 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.

26. Cancers in HIV Disease AIDS-DefiningVirus • Kaposi’s Sarcoma HHV-8 • Non-Hodgkin’s Lymphoma EBV, HHV-8 (systemic and CNS) • Invasive Cervical Carcinoma HPV Non-AIDS Defining • Anal Cancer HPV • Hodgkin’s Disease EBV • Lung • Leiomyosarcoma (pediatric) EBV • Hepatoma HBV, HCV

28. - United States, 1996-2002 Non-AIDS Defining Cancers that are Increased in People with AIDS Source: Engles et al., AIDS, 2006, 20, 1645-54

29. AIDS Malignancy Consortium (AMC) • Evaluate clinical interventions for the treatment and preventionof 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

30. AMC Clinical Sites Core sites Affiliated sites

31. AMC International Sites Mumbai Chennai Abuja, Nigeria Eldoret, Kenya Kampala, Uganda Lilongwe, Malawi Harare, Zimbabwe Sao Paolo, Brazil Johannesburg South Africa Core Sites Collaborative Sites

32. 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 , krowns@mskcc.org Mostafa Nokta, MD, PhD, mostafa.nokta@nih.gov

33. 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.

34. ACSR Collaborations

35. The HIV+ Tumor Molecular Characterization Project (HTMCP): • 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)

36. Sites of Research Training Awards in HIV-Associated Malignancies 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 Nigeria Uganda (2) Cameroon Kenya Rwanda Tanzania Zambia South Africa Geraldina Dominguez, PhD domingug@mail.nih.gov

37. Cancer Centers Comprehensive Cancer Centers Cancer Centers Dr. Hasnaa Shafik shafikh@mail.nih.gov Planning Centers

38. 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

39. CFAR Map Dr. Geraldina Dominguez domingug@mail.nih.gov

41. 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

42. 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, prickril@mail.nih.gov • NCI Summer Curriculum in Cancer Prevention https://cpfp.cancer.gov/summer/summer.php Registration open November 15, 2013 All Countries

43. http://oham.cancer.gov

44. International Clinical Trials Portal www.cancer.gov/clinicaltrials/international • Web-based “tool box” for international cancer researchers • Focus on collaboration between NCI and investigators outside the U.S.

45. 14th International Conference on Malignancies in AIDS and Other Acquired Immunodeficiencies (ICMAOI) 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 More Information can be found at: http://oham.cancer.gov/