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Appendix V: Update on the HHS/NIH AIDS International Research Program for the OGAC Strategic Plan


The President's Emergency Plan for AIDS Relief: First Annual Report to Congress
Office of the U.S. Global AIDS Coordinator
May 23, 2005
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The U.S. Department of Health and Human Services/National Institutes of Health (HHS/NIH) response to the AIDS pandemic requires a unique and complex multi-institute, multidisciplinary global research program. HHS/NIH has developed a comprehensive biomedical and behavioral research program to better understand the basic biology of HIV, develop effective therapies to treat and control HIV disease, and design interventions to prevent new infections from occurring. Perhaps no other disease so thoroughly transcends every area of clinical medicine and basic scientific investigation, crossing the boundaries of the HHS/NIH Institutes and Centers. HHS/NIH-sponsored HIV/AIDS research continues to provide the important scientific foundation necessary to design, develop and evaluate new and better vaccine candidates, therapeutic agents and regimens, and prevention interventions.

Since the early days of the epidemic, HHS/NIH has supported research efforts in countries affected by HIV and AIDS. Beginning in 1984 with a research project in Haiti and the establishment of Project SIDA in 1985 in what was then Zaire, HHS/NIH has maintained a strong international AIDS research portfolio. HHS/NIH has expanded its research effort to encompass approximately 90 countries around the world. It is important to point out that the majority of HHS/NIH international AIDS research funds support U.S-based AIDS researchers to conduct research in collaboration with scientists in international settings. Some funds are awarded directly to investigators in foreign research institutions. Results of this research benefit not only the people in countries where the research is conducted but people affected by HIV/AIDS worldwide.

HHS/NIH FY 2006 Plan for HIV-Related Research and AIDS Research Priorities
In accordance with the HHS/NIH Revitalization Act of 1993, the Office of AIDS Research (OAR) has developed the HHS/NIH FY 2006 Plan for HIV-Related Research and the fiscal year 2006 HHS/NIH comprehensive AIDS research budget. One component of the overall document is the strategic plan for international AIDS research. The international research plan shapes HHS/NIH investments in biomedical and behavioral AIDS research and provides the framework to translate critical research findings to benefit populations desperately in need around the world, particularly in resource constrained countries. The plan serves as the framework for developing the annual HHS/NIH AIDS research budget; for determining the use of HHS/NIH AIDS-designated funds; for tracking and monitoring AIDS-related expenditures; and for informing the scientific community, the public, and the AIDS-affected community about HHS/NIH AIDS research priorities.

HHS/NIH-sponsored international research includes efforts to develop HIV vaccine candidates and chemical and physical barrier methods, such as microbicides, to prevent sexual transmission; behavioral strategies targeted to the individual, family, and community to alter risk behaviors associated with sexual activity and drug and alcohol use; drug and non-drug strategies to prevent mother-to-child HIV transmission; therapeutics for HIV related co-infections and other conditions; and approaches to using antiretroviral therapy in resource poor settings.

In fiscal year 2006 HHS/NIH's overarching priority is on the discovery, development, and preclinical testing of additional HIV vaccine candidates. The evaluation of an AIDS vaccine will require extensive testing in the United States and in international settings where there is a high incidence of HIV. Priority is placed on moving promising vaccine candidates into large-scale clinical trials to evaluate their potential for efficacy.

Key HHS/NIH AIDS International Research: Program Activities

  • The Partnership for AIDS Vaccine Evaluation (PAVE) was established as a voluntary consortium of U.S. government agencies (HHS/NIH, HHS/CDC, and DoD) and key U.S. government-funded organizations, including the International AIDS Vaccine Initiative (IAVI), involved in the development of HIV/AIDS preventive vaccines and the conduct of HIV vaccine clinical trials. The goal of PAVE is to achieve harmonization and increased operational and cost efficiencies in the development and clinical evaluation of HIV vaccine candidates.

  • HHS/NIH has served in a lead role in the formation of the Global Enterprise for HIV/AIDS Vaccine Development, a consortium for accelerating HIV vaccine development formally endorsed by the Group of Eight nations. The strategic plan for the vaccine enterprise was published on January 18, 2005. (http://www.plosmedicine.org/perlserv/?request=getdocument& doi=10.1371/journal.pmed.0020025)

  • As part of the vaccine enterprise, HHS/NIH is currently soliciting for a Center for HIV/AIDS Vaccine Immunology (CHAVI) which will establish a "virtual" vaccine center. This initiative is expected to be partnered with other private and foreign country initiatives. An award is expected in 2005.

  • The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of non-vaccine interventions designed to prevent HIV transmission. HPTN carries out its mission through a network of investigators from more than 24 international sites partnered with a leadership group comprising three U.S.-based institutions. HPTN has sites in Africa, Asia, and North and South America.

  • The HIV Vaccine Trials Network (HVTN) is a coordinated global network for the conduct of HIV vaccine clinical trials at U.S. and international sites. HVTN conducts phase I, II, and III clinical trials, from evaluating candidate vaccines for safety and the ability to stimulate immune responses to testing vaccine efficacy.

  • The Comprehensive International Program for Research on AIDS (CIPRA) provides direct funding of foreign investigators. It is designed to provide long term support and enhance developing-country capabilities to conduct research relevant to their populations. CIPRA supports research and development in institutions to develop practical, affordable, and acceptable methods to treat HIV/AIDS in adults and children.

  • The Adults AIDS Clinical Trials Group (AACTG) is a network of clinical sites at major medical centers and academic institutions that conduct Phase I, II, and III clinical trials of drug regimens for HIV disease and its complications in adults. AACTG has 34 sites in the United States and 12 international sites.

  • The Pediatric AIDS Clinical Trials Group (PACTG) is a global network that conducts phase I, II, and III clinical trials of regimens to treat HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women. PACTG has 39 sites in the United States and 14 international sites.

  • The AIDS International Training and Research Program (AITRP) supports HIV/AIDS and related TB international training for health scientists, clinicians, and allied health workers from developing countries. The primary goal of this program is to build biomedical and behavioral research capacity for the prevention of HIV/AIDS and related TB infections. AITRP supports grants to U.S. academic and medical institutions, which have developed working relationships with institutions in collaborating countries. AITRP helps to facilitate research efforts supported by other NIH institutes and centers and to establish long-term collaborations between U.S. and international researchers.

  • HHS/NIH international AIDS programs provide important support for 1) developing research sites through establishment of stable, targeted cohorts, development of recruitment strategies, and enhancement of laboratory, clinical, and data management capabilities; 2) increasing the number of scientists, clinicians, and health care workers trained in basic, clinical, and behavioral research, data management, and ethical considerations; 3) developing research collaborations; and 4) transferring appropriate clinical and laboratory technologies.



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