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 September 23, 2002 at the Natcher Building on the National Institutes of Health (NIH) campus in Bethesda, Maryland. Dr. King Holmes chaired the meeting.
Report from the Director - Dr. Tramont
Dr. Tramont introduced Dr. Holmes as the new chair of the ARAC. He welcomed Dr. Phyllis Kanki, the newest ARAC member, and announced that Dr. Brooks Jackson will serve as a liaison to Office of AIDS Research Advisory Committee (OARAC). He thanked Dr. Haynes and Ms. Saint Cyr, who are rotating off, for their services and he introduced Dr. Kevin Ryan as the new Chief of the Prevention Services Branch at DAIDS. He also described two new offices that are being created at DAIDS as part of the Office of the Director -- the Office of Clinical Research Policy & Resources and the Office of International Research.
The Strategic Planning Working Group met in March 2002 to look at the Division's research portfolio and structure. The effort has "fallen off track" because of the departure of key DAIDS staff and because Dr. Tramont needed to devote his energies to helping his wife recover from a major illness. He proposed shifting much of the strategic planning responsibility to ARAC.
Dr. Tramont briefly summarized Dr. Fauci's remarks to Council concerning HIV/AIDS related activities, including the transfer of Department of Defense HIV research efforts to DAIDS, which despite some delays, is proceeding.
ARAC: Advisory Role and Planning Strategies-Drs. Edmund Tramont, King Holmes, and Lawrence Deyton
During the last meeting, Dr. Tramont asked the Committee for stronger input on a broad range of issues affecting the research agenda. Dr. Deyton had offered to lead a small group that would consider how the Committee might best make such a shift. Drs. Ruff, Lewis, and Kanki, and Ms. Siskind volunteered to work with him. The group drafted a proposal based on the three charges in the ARAC charter: 1) review of scientific issues, gaps, and opportunities; 2) review of programs and how well they are addressing these issues, gaps and opportunities; and 3) review and approval of concepts for funding. The group suggested that ARAC use the Office of AIDS Research (OAR) research plan as a foundation for its discussions because the plan is thorough and up to date. They recommended that ARAC categorize the topics addressed in the OAR plan and discuss the DAIDS portfolio with respect to these areas in a series of two-day meetings that would cover both the scientific aspects of the topics and the DAIDS portfolio in these areas. In this way, ARAC would review most major scientific areas every two to three years.
Dr. Holmes thanked the group for identifying the key issues. During the subsequent discussion, some members asked how they might receive enough information to discuss such broad topics and keep current with DAIDS' activities. One suggested that they receive all meeting materials, including slides, in advance. One Committee member questioned whether it would take too long to get around to all of the pressing issues under the schedule proposed. Others suggested that the Committee address focused, manageable topics as opposed to broad areas.
Another proposal that was discussed with favor was that the Committee continue to have short consensus reviews, which have been streamlined effectively by the web-based ARAC reviews implemented by DAIDS, and begin to 1) review research needs and opportunities in specific areas selected by the Division, 2) decide which research questions are of highest priority, 3) determine which of these research priorities are or are not being addressed by current or planned NIAID programs or other outside programs, 4) recommend new initiatives for development to address these unmet needs and priorities, and 5) review the subsequent concept proposals in these areas. In addition to discussing specific research questions or areas, other critical issues effecting DAIDS-funded research could also be addressed by the Committee.
As a first step in identifying topics/issues appropriate for ARAC discussion, it was agreed that staff would develop a series of questions based on the elements of the OAR plan in which DAIDS has a major research interest and/or specific concerns/needs of the Division. Staff would then prioritize them with respect to scientific priorities; opportunity, especially for leveraging resources through collaboration; and also the need to address these issues to facilitate the consideration of programs scheduled for renewal. Essentially, the view of ARAC members was that it is best for ARAC to review progress and plans for renewal of existing and proposed new programs in the context of a consensus on the research needs, opportunities and priorities that such programs aim to address. Agenda items would be selected from this list, with the understanding that the Committee would begin simply and get more ambitious over time. The Committee and staff suggested a number of possible meeting formats, including one long afternoon that would extend into the evening, or a day and a half meeting to address major issues. However, the format for the meeting will be determined once a topic is selected.
It was also suggested that the Committee begin to transition to this new format by discussing at least one issue at the next meeting.
AIDS Vaccine Research Working Group-Dr. Jim Bradac
Dr. Bradac briefed the Committee on the history of AVRWG, which was initially established to provide direction and oversight to NIH for HIV/AIDS vaccine research. The working group, initially chaired by Dr. David Baltimore and now chaired by Dr. Bart Haynes, addresses difficult issues confronting the field and suggests new mechanisms for advancing the field. Toward this end, the AVRWG meets approximately 3 times a year and organizes a biannual International AIDS Vaccine Meeting.
Concept Reviews: Therapeutic Research Program-Dr. Fred Batzold
Dr. Batzold reviewed the status of the therapeutic research program. DAIDS has established programs in developed countries mainly through solicited research covering all aspects of pediatric and HIV disease. Key challenges include the changing demographics of HIV/AIDS in the U.S., the high rate of HIV-TB coinfection in many regions of the world, the development of resistance to currently available drugs, and the paucity of new therapies.
Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP)
Dr. Batzold requested the continuation of IPCP, which helps move innovative treatment concepts from preclinical to clinical studies. Upcoming projects include the development and validation of new therapeutic targets and the development and evaluation of small molecule inhibitors. The program will grant approximately seven 4-year awards at a cost of $7.5 M in the first year.
The reviewers acknowledged the value of this program. They requested that DAIDS develop a rationale for excluding research areas, so the program will not support areas of research that are already well funded. They suggested that investigators define their expectations clearly and that the background information on principal investigators include a description of their past projects and successes. The committee approved this concept.
International Studies of AIDS Associated Coinfections (ISAAC)
ISSAC will support clinical research on HIV and endemic coinfections, particularly those involving TB and malaria, at established centers in regions with limited resources and a high incidence of HIV. This work will address the safety of HIV therapeutics with coinfection and improve the standard of care for patients with these coinfections. The program will also generate information on the patterns of coinfection and disease progression, as well as bidirectional interactions. This 5-year program will cost $3M in its first year.
The reviewers said the first priority of this concept should be the identification of problems specific to various regions and the selection of one or two regions for focused pilot trials, improved management, and the study of coinfection. Independent projects should be coordinated. Significant support of infrastructure, such as microbiology labs, will be essential. The Committee approved this concept.
Pathogenesis of M. tuberculosis and HIV Co-infection in Humans
This 5-year concept would stimulate research on the pathogenic interactions of TB and HIV. It will cost $3M in its first year.
The reviewers agreed that pathogenesis of TB in people with HIV/AIDS is both a high priority and a gap in NIAID's portfolio. The Committee approved this concept.
Patient Safety Monitoring in International Laboratories
This 7-year concept will establish laboratories in areas with high infection rates and limited resources, and help existing labs in these regions establish proficiency-testing programs and achieve certification. These labs would serve the prevention and vaccine programs as well as the therapeutics program and monitor drug resistance in sub-Saharan Africa. The program will cost $3M in its first year.
The reviewers found this to be an important but underfunded initiative. They asked for options through which the contract could be expanded in the future. The Committee approved this concept. They would like to review this program in a few years and study how well this and similar programs are coordinated.
Innovative Strategies to Enroll Women and Minorities with HIV/AIDS into Research Trials (INSTART)
Current enrollment in clinical trials does not reflect the demographics of HIV infection. This 3-year concept will enable researchers to identify and overcome the barriers to participation of women and minorities in trials. It will cost $2M in its first year.
The Committee agreed that research is needed to determine how to recruit key populations into trials. They approved the concept.
Vaccine & Prevention Research Programs-Peggy Johnston
Dr. Johnston reviewed the scientific advances of the previous year, and the challenges that remain, including the need to elicit broadly neutralizing antibodies, induce correlates of immune protection, discover the correlates of immune protection, and expand our capacity to conduct trials in developing countries.
HIV Vaccine Research and Design (HIVRAD)
Dr. Johnston asked for the renewal of HIVRAD, a program that supports multidisciplinary, middle-pipeline vaccine research and development projects, including the development of animal models. The renewal would extend over 3 years, with a first-year cost of $4M. NIAID has made eight awards through this program since its inception in 1998. Several innovative grants have made use of this mechanism.
The reviewers were strongly in favor of this program, which they called effective and an essential avenue for advancing ideas. The Committee approved this concept.
Genetic Variation of HIV and Related Lentiviruses
Dr. Johnston also requested the renewal of a program to clone, sequence, and analyze HIV and related genomes from around the world and provide this genetic information, clones, and related reagents to the research community. The first year of this 5-year program will cost less than $1M. This work remains necessary because immunotyping is still not feasible.
The reviewers questioned whether similar programs already provide this service. Dr. Johnston explained that this programs complements others. The Committee approved this concept.
Vaccine Clinical Research Laboratory Support
Dr. Johnston asked for the expansion of current clinical research laboratory support for products approaching Phase I trials. This expansion, which would cost $1.2 M this year and $2.2 M next year, would cover virologic and immunologic assays. This 7-year program began in 1998.
The reviewers supported the proposal, noting that researchers in the central laboratories are pleased with the contractor's work. The Committee approved the concept.
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