Ed Tramont, M.D., Director, DAIDS
The AIDS Subcommittee of the National Advisory Allergy and Infectious Diseases Council and the AIDS Research Advisory Committee (ARAC) met jointly on May 30, 2002, at the Natcher Building on the National Institutes of Health (NIH) campus in Bethesda, MD. Dr. John Phair chaired the meeting.
Report from the Director - Dr. Tramont
Dr. Tramont updated the Committee on several important areas of activity and staff changes.
The Pediatric AIDS Clinical Trials Group (PACTG) was renewed in March 2002, with a $36 million budget for 18 university-based clinical sites, a statistical and data management center, and a coordinating and operations center. The network will also fund four international sites in South Africa and Thailand, and the National Institute of Child Health and Human Development will continue to support 35 sites that participate in PACTG research.
In January 2002 the White House Office of Management and Budget transferred the oversight and management of the Department of Defense HIV Research and Development Program of the US Army Medical Research and Materiel Command (USAMRMC) to NIAID. This $38M program came without funding but will give NIAID more flexibility in accomplishing its mission. For example, the Walter Reed Army Institute for Research, (WRAIR) a component of the USAMRMC, has an HIV vaccine trial scheduled to begin this fall in Thailand that will continue to move forward. DAIDS will brief the Committee more thoroughly on this trial at the September meeting.
NIAID has created a number new job opportunities due to the increased funding and responsibility for biological defense research. Several DAIDS' staff have taken new positions to work in this area.
In other staffing changes, Dr. William Duncan, Mr. Tom LaSalvia, and Dr. Michael Gross have left DAIDS for new positions. Dr. Kagan was named DAIDS' permanent Deputy Director, Sandra Bridges chief of the Targeted Interventions Branch, and Dr. Whitescarver, the Director of the NIH Office of AIDS Research. Several DAIDS employees were given the HHS Secretary's award for distinguished service.
Dr. Tramont acknowledged and thanked Dr. Phair, who will be rotating off the Committee. Dr. King Holmes will replace him as chair effective July 2002.
Concept Review: Vaccine Research and Prevention Program - Dr. Johnston
Dr. Johnston asked the Committee to approve changing the funding mechanism of two existing programs-the Preclinical/Clinical Program in Topical Microbicides and the Integrated Preclinical/Clinical AIDS Vaccine Development Program-from P01grants to U19 cooperative agreements. This will allow for the additional staff involvement required to ensure full compliance with human subjects policies and guidelines, and make the programs more flexible. Both programs will continue to support pilot studies of multiproject, investigator-initiated research. Dr. Johnston explained that if NIAID receives more high-quality proposals than it anticipates, staff could adjust the budget or request additional funding. If grantees elect to abandon promising projects, NIAID can carry them forward. The Committee agreed to change the funding mechanism; first-year costs will be a maximum of $8M.
Opportunities for Partnering in International Research - Dr. Tramont and Dr. Kagan
Since more than 95 percent of the new cases of HIV-AIDS are occurring in developing countries, NIAID must work internationally to fulfill its mission to help end the HIV-AIDS epidemic. To strengthen NIAID's international efforts, Dr. Tramont suggested that NIAID partner with other governmental and nongovernmental agencies that have established international programs.
Dr. Kagan briefed the Committee on NIAID's mandate with respect to infectious and parasitic diseases worldwide. He explained that NIAID's research efforts must be built upon stable programs that provide sustained care and will likely require new funding mechanisms that will help retain talented professionals and create sustainable research projects. Issues also exist regarding the standard of care NIAID should provide research volunteers in the developing world.
Dr. Kagan reviewed the partnerships NIAID has already established to fund worldwide biomedical research on HIV-AIDS. During discussion, the Committee suggested that partnerships involve the behavioral as well as the biomedical sciences and asked how NIAID takes the ethical standards of other countries into consideration. Dr. Tim Mastro of the Centers for Disease Control (CDC) and Mr. David Stanton of the U.S. Agency for International Development (USAID) then spoke to the Committee about the possibility of NIAID partnering with their agencies.
Centers for Disease Control and Prevention - Dr. T. Mastro
Dr. Mastro is associate branch chief for international research in CDC's AIDS division and heads their HIV vaccine section. He described CDC's organizational structure and international work in HIV/AIDS. After many years of working in a handful of countries, CDC now has HIV prevention programs in 22 nations. The CDC selects the countries with which it will work on the basis of compelling need or an existing relationship and consults with the international community through informal means as opposed to an external review committee. The success of these programs is rooted in the bilateral, often personal, relationships of CDC staff with host ministries of public health. CDC has a memorandum of agreement with each of the host countries with which they have programs. Their key accomplishments include characterizing AIDS in Africa; understanding HIV-2 epidemiology in West Africa; describing AIDS in Asia, particularly Thailand; prevention of mother-child transmission; and reducing the morbidity and mortality of HIV-infected tuberculosis patients. Their HIV prevention work is done in collaboration with USAID.
CDC's AIDS activities fall under their Global AIDS Program (GAP) and includes HIV prevention, voluntary counseling and testing, prevention and treatment of STDs, treatment and care, operational research on these programs, and maintenance of program infrastructure. CDC has often had to create and improve services to ensure a reasonable standard of care for the patients in their programs. Dr. Mastro briefed the Committee on CDC's work in four areas: vaccines, microbicides, STD prevention, and mother-child prevention, describing research programs in Thailand, Cote d'Ivoire, Kenya, and Botswana. He noted a number of opportunities for collaboration. For example, CDC has no mechanism for reviewing clinical products but needs this information. Committee members also suggested that the agencies might collaborate on projects related to tuberculosis-HIV coinfection.
The Committee discussed the status of health care at GAP sites, which varies greatly. Dr. Mastro said that CDC works to make their programs sustainable by partnering with the host country and hiring staff that can remain on the project for the long-term. He cautioned that most ministries of health regard basic research as a luxury, so CDC often expands its research programs to answer pressing operational questions. CDC's budget includes about $10 to $12M for research in its four field stations. The GAP budget is $150M for 22 countries; about $10M of this funding is for research.
Dr. Mastro said that U.S. ambassadors insist that U.S. programs in host countries be coordinated and that staff of U.S. agencies be united. Much of this coordination occurs in the host countries. CDC employees working overseas do so via a formal State Department mechanism. They report to the U.S. Ambassador and the Minister of Health or his or her designee, as well as to their supervisors in the U.S.
USAID - D. Stanton
USAID, the Government's foreign assistance agency for economic development, began its HIV-AIDS programs in the mid-1980s. USAID now has HIV/AIDS programs in more than 40 countries and regions, 28 of which are priority areas that receive substantial funding. The missions in host countries administer much of this funding, which makes the agency heavily decentralized. USAID has a substantial field presence in each of these priority countries. They support large programs for voluntary counseling and testing. They have done pioneering work in behavioral surveillance, behavioral communications, behavioral change, community mobilization, orphan programs, programs of economic support for affected families, quality assurance of medical services, the prevention of mother-to-child transmission, the provision of comprehensive care, and drug management. They are now working to develop food aid programs, especially for drought areas. Much of their work is done through locally financed nongovernmental organizations.
USAID's priorities with respect to collaboration fall into three categories: 1) operations or implementational research, 2) the development of rapid testing for malaria and HIV, simple diagnostics for gonorrhea and chlamydia, and single-dose packaging for navaropine, and 3) research, including work on vaginal microbicides and the collaboration with International AIDS Vaccine Initiative. All research funding is administered in Washington, DC. Mr. Stanton emphasized the need for behavioral research and suggested partnering with NIAID as they develop biomedical interventions to study how they affect community and individual behavior. Other areas of possible collaboration include service delivery, preparing communities for vaccine trials, and care and treatment, particularly assistance with laboratory functioning. USAID needs at least rudimentary diagnostic monitoring capacities and, possibly, advice on what surrogates may be robust enough to rely on for diagnosis and monitoring. They also need guidance with respect to the standardization of antiretroviral therapy. Challenges facing both agencies include deciding how to buy drugs, ethics, the management of injection drug use, and circumcision. Mr. Stanton suggested that a high-level summit on ethics is also needed.
The Committee discussed whether NIAID needs staff in developing nations and Dr. Tramont raised the possibility of having NIAID train employees of other Federal agencies to represent them. The Committee agreed to pass a resolution strongly urging NIAID to collaborate with other agencies. Dr. Phair will draft this resolution, which will be voted on during the September meeting.
Demonstration of Web-Based Concept Review - B. O'Neill and R. Siskind
DAIDS has developed a pilot Web site that will facilitate the ARAC concept review process and allow all Committee members to participate more extensively in concept development and review. The Web site will be operational in time to pilot at the September meeting. Staff are developing a manual on how to use the Web site that is expected to be available over the summer. The Committee liked the Web site and thought it would both save time and make the meetings more productive.
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