John Y. Killen, M.D., Director, DAIDS
The meeting was chaired by Dr. Gary Nabel, Chairman of the AIDS Research Advisory Committee (ARAC). Dr. Killen opened the meeting by greeting the committee members and thanking them for their participation. He welcomed three new members to the ARAC: Drs. Raphael Dolin, Marian Neutra, and Charles Rinaldo. Dr. Killen noted that Dr. Edmund Tramont would be completing his term as a member of the AIDS Subcommittee and thanked him for his dedicated service. He also mentioned staff changes within the Institute and Division of AIDS (DAIDS) and congratulated Division staff who recently received awards.
Dr. Killen then addressed budget issues, beginning with a brief review of the FY 1997 funding levels proposed by the President, the House, and the Senate. He reported that the House and Senate appeared close to reaching agreement on an omnibus appropriations bill for FY 1997, thus reducing concerns that FY 1997 might begin under a continuing resolution. Within this bill, the research institutes of the NIH are projected to receive a 6.5 percent average increase from the FY 1996 funding level.
In addressing recent scientific developments, Dr. Killen cited recent findings in chemokine receptor research that have the potential to elucidate early stages of acute infection and suggest possible targets for both therapeutic interventions and vaccine prototypes. He noted that NIAID-supported investigators, both intramural and extramural, have been at the forefront of chemokine receptor research.
Dr. Killen also reported on results from a study by NIAID-supported scientists that suggest that using a protease inhibitor in combination with nucleoside analogs is effective in treating HIV-infected patients. Dr. Killen explained that the Acute Infection Network, which would be discussed later in the meeting, would be pursuing this promising development.
Next, Dr. Killen stated that NIAID representatives participated in the Keystone National Policy Dialogue on the Establishment of Studies to Optimize Medical Management of HIV Infection. The group was asked to develop a framework for optimal study of the medical management of HIV infection. The primary recommendation in the group's report called for the establishment of an independent, public-private partnership called the Forum for Collaborative HIV Research. Its goal will be to foster information exchange and encourage appropriate stakeholders to conduct new studies to address critical questions about optimal treatment of HIV disease. NIAID and NIH will continue to actively participate in and support this group.
With regard to vaccine research and development, Dr. Killen reported that the Division's Vaccine and Prevention Research Program (VPRP) has been focusing on whether vaccines can induce T-cell immune responses against HIV strains and clades found around the world and, if not, how to make such vaccines region-specific. He also mentioned that new animal data have revealed protection of nonhuman primates against a mucosal challenge by prime-boost regimens. In addition, AIDS Vaccine Evaluation Group (AVEG) studies of canarypox-HIV constructs have shown that a vaccine candidate containing gag and envelope elicits more CD8+CTL than a vaccine candidate containing envelope only. Results of trials using a high dose of this improved construct will be available in six to eight months.
Finally, Dr. Killen provided follow up on the May 1996 ARAC discussion of recommendations contained in the report from the NIH AIDS Research Program Evaluation Working Group and mentioned that the Office of AIDS Research (OAR) is in the process of developing a plan for implementing the recommendations. He concluded by reporting that two external program reviews were held during the past several months, noting that Dr. James Curran would present the report from the HIVNET review at this meeting. A report on the recent review of the National Community Advisory Boards and Community Constituency Groups will be presented at the January meeting.
HIV Network for Prevention Trials (HIVNET): Ad Hoc Review--Dr. James Curran
Dr. Killen introduced the presentation of the report from the HIVNET external review by stating that the review was conducted as part of the Division's ongoing effort to periodically review its major research programs, and in response to a recommendation in the report prepared by the OAR Advisory Council's NIH AIDS Research Program Evaluation Working Group. In conjunction with the OAR, DAIDS convened the review panel in June 1996; Dr. James Curran served as chair.
Dr. Curran then reviewed the methods and findings of the 18-member ad hoc panel. The panel was charged with assessing HIVNET's accomplishments and future plans in the context of AIDS prevention research at the NIH. HIVNET investigators provided the panel with a comprehensive plan for the research group, which included detailed information on its research agenda, organization, and management structure. Other Institutes involved in AIDS prevention research at the NIH also provided overviews of their activities and interactions with HIVNET.
Dr. Curran reported that in spite of the fact that HIVNET is a new and still-evolving program, its broad mission and the complexity of a 17-site network, HIVNET has been very successful and must continue in its original mission as a network for prompt and scientifically sound HIV vaccine evaluations.
Dr. Curran noted that because of the rapid spread of HIV worldwide and the perceived lack of U.S. concern about the disease in other countries, HIVNET's work on international prevention research studies is crucial. The panel reaffirmed the need for HIVNET to maintain a clear focus on vaccine research and development, particularly the international component. In this context, Dr. Curran also cited the panel's recommendation that NIAID develop evaluation criteria for international sites.
Dr. Curran said that the panel also recommends that the OAR actively ensure close collaboration with the other entities involved in prevention research, including the National Institute of Mental Health, the National Institute for Drug Abuse, and the Centers for Disease Control. Coordination and collaboration are particularly important in planning and implementing behavioral science interventions.
The panel further recommended that HIVNET's prevention research priorities, as a fraction of the total NIH prevention research effort, must be viewed within the context of the overall NIH prevention research agenda. The panel stated that HIVNET research must be conducted and reviewed according to the highest scientific standards, that the network's scientific progress and priorities be regularly reviewed, and that NIAID seek scientific advice beyond its traditional research constituents to ensure adequate peer review of prevention proposals. Further, the panel recommended that fully developed research protocols should be independently peer-reviewed prior to final approval, with a focus on objectives, methods, resource requirements, and implementation strategy. The committee endorsed the panel's report.
Concept Review: Basic Research on Mucosal Immune Responses to HIV Vaccines-- Dr. Schultz
The objective of this initiative is to support investigator-initiated research defining mucosal immune responses to specific HIV vaccine candidates and to develop animal models, mucosal strategies, methodology, and assay reagents to study mucosal immunity in humans and primates. The concept was approved.
Concept Review: Strategic Program for Innovative Research on AIDS Vaccines (SPIRAV), including the National Cooperative Vaccine Development Groups (NCVDG)--Drs. Schultz and McNamara
This initiative will support multidisciplinary groups of preclinical and clinical investigators engaged in the design and evaluation of innovative, novel approaches to HIV vaccines. It encompasses the continuation of the NCVDG program, which focuses on the preclinical design and development of vaccine concepts and their evaluation in non-human primates, and the proposed SPIRAV program, envisioned as a resource for academic investigators to enter small preliminary clinical studies by providing the funds to create the vaccine and test it, then develop design improvements. The concept was approved.
Concept Review: Integrated Preclinical and Clinical Program for Novel HIV Therapies [Strategic Program for Innovative Research on AIDS Treatment (SPIRAT) and National Cooperative Drug Discovery Groups for HIV (NCDDG-HIV)] --Dr. Sarver
This initiative will support a multidisciplinary program for investigator-initiated research for the discovery and development of novel therapeutic concepts for the treatment of HIV disease and for the transition of new therapeutics to pilot clinical studies. It will consolidate the NCDDG-HIV program, which supports preclinical discovery of new therapeutic agents, and the SPIRAT program, which supports pilot clinical studies of innovative treatment modalities. The committee approved the concept with one modification.
Concept Review: Acute HIV Infection and Early Disease Research Network--Dr. Pettinelli
The objective of this initiative is to expand the pathogenesis and pilot clinical research conducted under the FY 1997 Acute Infection Initiative. The initiative will also permit an increase in the number of participating sites and the conduct of multicenter confirmatory studies for the rapid evaluation of the impact of therapeutic intervention on HIV disease. The committee approved the concept.
Concept Review: Virology Quality Assurance Program--Dr. Reichelderfer
This initiative provides for the continuation of a centralized resource for comparability of data across all of the NIAID/DAIDS-supported clinical trials in therapeutics, epidemiology, and vaccines. The program assures quality in virology laboratories to ensure data integrity; creates and standardizes virologic assays for clinical studies; and analyzes statistics to assess assay variability and reproducibility. The committee approved the concept.
Concept Review: Drug Discovery Research for Opportunistic Infections--Dr. Hafner
This initiative is intended to support the discovery of drugs for the treatment of opportunistic infections as well as basic research on drug discovery, and to stimulate the development of new agents that will exploit the potential targets identified by basic research. The committee approved the concept.
Concept Review: Women's Interagency HIV Study (WIHS); WIHS Data Management and Analysis Center (WDMAC)--Dr. Miotti
This initiative will continue support for a multicenter, longitudinal cohort study of HIV/AIDS in women. Research will focus on HIV pathogenesis and clinical outcomes, particularly those outcomes that are women-specific. Collaborations on basic research studies will also be encouraged. The WDMAC will provide statistical and analytical expertise for the analysis of WIHS data, for planning of substudies within the WIHS, and for investigators involved in collaborations with the WIHS. The committee approved the concept.
Concept Review: AIDS Research and Reference Reagent Program--Dr. Sharma
The proposed initiative will continue support for a program that acquires and distributes state-of-the-art AIDS-related research and reference reagents and to provide current information through print and electronic media in order to facilitate HIV/AIDS research. The concept was approved by the committee.
Concept Review: Centers for AIDS Research (CFARs)--Dr. Young
The initiative proposes continuation of the Centers for AIDS Research (CFAR). The objective of the CFAR program is to support a multidisciplinary environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. New elements included in this initiative are intended to make the CFAR program more responsive and available to the broader research community; to have each CFAR develop strategic plans, milestones and goals; and to promote industry collaboration. The committee approved the concept with one modification.
Concept Review: Statistical and Clinical Coordinating Center (SACCC) for the Women and Infants Transmission Study (WITS)--Dr. Lew
The SACCC's primary objective is to provide data management, quality control, and statistical analysis for the Women and Infants Transmission study (WITS). It also provides support for collaborative studies for other cohorts; provides data management for repository specimens; coordinates enrollment and referral of patients between observational and clinical studies supported by DAIDS; and provides general statistical assistance for WITS and DAIDS for special projects on HIV infection and disease. The committee approved the concept.
Concept Review: Clinical Research Products Management Center--Dr. Martinez
The center supports the AIDS clinical trials effort by providing a centralized management distribution center for clinical study products used in DAIDS-supported clinical trials. The committee approved the concept.
(Please phone Jean Noe, Acting Executive Secretary, ARAC, at 301-402-0545 if you wish to receive a copy of the ARAC/AIDS Subcommittee Joint Meeting Summary via fax.)
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