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NIH National Advisory Allergy and Infectious Diseases Council

Minutes of Meeting: September 20, 2010

The 166th meeting of the National Advisory Allergy and Infectious Diseases Council (NAAIDC) convened at 10:30 a.m. on Monday, September 20, 2010, in Salon D, Bethesda North Marriott Hotel and Conference Center. Dr. Anthony S. Fauci, director, National Institute of Allergy and Infectious Diseases (NIAID) presided as chair.

In accordance with the provisions of Public Law 92-463, the meeting was open to the public from 10:30 a.m. to 11:40 a.m. and from 12:45 p.m. to 5:30 p.m. The meeting was closed to the public from 8:30 a.m. to 10:00 a.m. and from 11:40 a.m. to 12:00 p.m. for review and consideration of individual grant applications. Notice of the meeting was published in the Federal Register.

Council Members Present:

  • Dr. Ann Arvin
  • Dr. Robert Brooks
  • Dr. Carol Carter
  • Dr. Connie Celum
  • Dr. Nelson Chao
  • Dr. Satya Dandekar
  • Dr. Sharon Kiely
  • Mr. William McLin
  • Dr. Louis Picker
  • Dr. Regina Rabinovich
  • Dr. Marc Rothenberg
  • Dr. Samuel Stanley
  • Dr. Jenny Ting
  • Dr. Christel Uittenbogaart
  • Dr. Christopher Walker
  • Dr. Richard Whitley
  • Dr. David Wilkes

Ex Officio Members Present:

  • Dr. Victoria Davey
  • Dr. Anthony Fauci
  • Dr. Bruce Gellin
  • Dr. Rima Khabbaz

Ex Officio Members Absent:

  • MG James Gilman
  • COL Kent Kester

Council Members Absent:

  • Dr. George Siber

NIAID Senior Staff Present:

  • Dr. Hugh Auchincloss
  • Dr. Carl Dieffenbach
  • Dr. Irene Glowinski
  • Dr. Marvin Kalt
  • Dr. Cliff Lane
  • Dr. Daniel Rotrosen

Table of Contents

I. Review of Grant Applications

The National Advisory Allergy and Infectious Diseases Council convened in closed session to consider applications in the areas of allergy and immunology, microbiology and infectious diseases, and AIDS.

Funding Actions: The Council reviewed 2,490 research and training applications with primary assignment to NIAID for a requested amount of $869,899,002 in first-year direct costs and recommended approval of 620 applications for $194,113,134 in first-year direct costs.

II. Remarks of the Director, NIAID—Anthony S. Fauci, M.D.

Dr. Fauci opened the Council session by welcoming visitors to the meeting. He acknowledged the contributions of five retiring Council members -- Drs. Robert Brooks, Satya Dandekar, Sharon Kiely, Marc Rothenberg, and David Wilkes -- and presented them with plaques, certificates, and letters of appreciation for their service.

Dr. Victoria Davey is the new Department of Veterans Affairs ex officio member. Council member Dr. George Siber and ex officio members Major General James Gilman and Colonel Kent Kester were unable to attend the meeting.

Consideration of Minutes of Previous Meeting

Council considered the minutes of the May 24, 2010, meeting and approved them as written.

Nominations and Appointments

In August, Dr. Francis Collins announced the appointment of Dr. Lawrence Tabak to replace Dr. Raynard Kington as the new principal deputy director of NIH. Other key appointments announced by Dr. Collins included Dr. Alan Guttmacher as the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Dr. Sally Rockey as the NIH deputy director for extramural research.

Staff and Organizational Changes

Dr. Fauci announced that Dr. Emily Erbelding is the new deputy director of the Division of AIDS.

Tributes and Awards

Dr. Fauci paid tribute to Dr. Robert M. Chanock who died in July. Dr. Chanock was a world-renowned virologist and former chief of NIAID’s Laboratory of Infectious Diseases.

The American Academy of Microbiology elected Dr. Byron Caughey, chief of the TSE/Prion Biochemistry Section at RML’s Laboratory of Persistent Viral Diseases, as a fellow. Dr. Jack Whitescarver, NIH associate director for AIDS Research and director of the NIH Office of AIDS Research, received the first International AIDS Society Presidential Award for his outstanding commitment to the global fight against HIV and his pioneering work in the field.

Budget Update

The FY 2011 President’s Budget for NIH is $32 billion, a 3.2 percent increase over FY 2010. The NIAID proposed allocation is approximately $5 billion; an increase of 3.3 percent over the FY 2010 appropriated level. Both the House and Senate versions of the FY 2011 budget include $50 million to launch the Cures Acceleration Network (CAN). The health care reform bill signed by President Obama on March 23, 2010, included CAN, a provision to support research for high-priority therapeutics, biologics, or medical devices that have not attracted funding from the private sector because they lack a commercial market.

NIAID will begin FY 2011 operating under a continuing resolution that could last up to four months. We will begin with a conservative funding approach. Our interim R01 payline is the 8.0 percentile. We will set our final paylines once we receive a final FY 2011 spending bill.

On August 19, HHS Secretary Kathleen Sebelius released the Public Health Emergency Medical Countermeasure Enterprise Review, which outlines a new medical countermeasures strategy to rapidly respond to emerging infectious diseases, pandemics, and bioterrorism. On behalf of NIH, NIAID will help lead this effort by supporting the Concept Acceleration Program (CAP). An additional $33 million in funding was authorized to support this effort.

Legislative Update

On May 27, 2010, Dr. Fauci testified before the House Energy and Commerce Committee on recent developments in the field of synthetic biology.

On June 22, Drs. Mike Kurilla and Dennis Dixon of the Division of Microbiology and Infectious Diseases briefed staff of the Senate Health, Education, Labor, and Pensions Committee about antimicrobial drug development.

On August 4, Dr. Fauci and Dr. Gary Nabel held a briefing on the NIH campus for staff of the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies. Topics presented included HIV/AIDS research and universal influenza vaccine research.

On August 9, Drs. Carole Heilman and Dan Rotrosen briefed staff for House Speaker Nancy Pelosi and the House Energy and Commerce Committee on vaccine safety research.

Dr. Fauci noted that House Appropriations Chairman David Obey is retiring. NIH is losing a strong ally and will miss him.

Other Information Items

Dr. Fauci began with an update on HIV/AIDS. NIAID published an RFA named after AIDS activist Martin Delaney. The purpose of the RFA, Martin Delaney Collaboratory Towards an HIV Cure, is to generate new ideas for curing HIV infection through partnerships among government, industry, and academia.

In July, the White House announced the U.S. National HIV/AIDS Strategy. The Division of AIDS played an important role in developing this strategy.

The XVIII International AIDS Conference in Vienna served as the forum for announcing the first successful microbicidal gel to prevent HIV infection in women.

On October 26, NIAID is holding a town hall meeting on the 2013 NIH/AIDS Clinical Trials Networks.

Dr. Fauci discussed the H1N1 influenza pandemic and the progress that has been made in developing a universal flu vaccine. He also presented statistics showing the increase in the number of cases of dengue and hemorrhagic fever. NIAID is sponsoring a Dengue Research Conference in San Juan, Puerto Rico, in February 2011.

Dr. Fauci gave brief updates on antimicrobial research, tuberculosis, malaria, and food allergy research.

III. Guest Speaker—Kathryn Zoon, Ph.D., Director, Division of Intramural Research, National Institute of Allergy and Infectious Diseases

Dr. Zoon presented the three priority areas of the Division of Intramural Research (DIR), including immunology and infectious diseases, biodefense and emerging infectious diseases, and HIV/AIDS.

DIR’s projected budget for FY 2011 is $362 million, which is a 2.5 percent increase over FY 2010. After accounting for increases in expenses, this is basically a flat budget.

Dr. Zoon announced personnel changes, including Dr. Jeffrey Cohen as the new chief of the Laboratory of Infectious Diseases, newly tenured investigators, and new tenure track and clinical tenure track investigators. Dr. Bryan Murphy retired as chief of the Laboratory of Infectious Diseases.

DIR is conducting several searches to fill vacancies. The Laboratory of Immunology is looking for a tenure track investigator. DIR is recruiting for a clinical tenure track investigator in tuberculosis, a tenure track for their program in systems biology, and a molecular immunologist in the Laboratory of Virology at Rocky Mountain. Finally, DIR will be conducting a search for one or two transition program fellows.

Dr. Zoon recognized DIR scientists who had received distinguished honors and awards. She also discussed facility renovations and collaborations in DIR’s international programs.

The Board of Scientific Counselors performed its peer review of DIR laboratories. All the labs reviewed received a rating of outstanding or excellent.

DIR recently opened the new NIAID primary immunodeficiency clinic. The clinic will diagnose and treat many primary immunodeficiencies.

Dr. Zoon concluded with an overview of DIR’s research programs on dengue and MRSA.

IV. Report of the Division of Allergy, Immunology, and Transplantation Council Subcommittee—Daniel Rotrosen, M.D., Director

Dr. Rotrosen opened the subcommittee Council meeting by welcoming all returning members of the National Advisory Allergy and Infectious Diseases Council Subcommittee. Dr. Rotrosen next took the opportunity to inform the subcommittee members that it was a great pleasure to have Dr. Daniel Salomon, Associate Professor, Scripps Center for Organ and Cell Transplantation present on the “Proteogenomics in Kidney Transplantation: From Discovery to Biomarkers.” He also noted that before we hear Dr. Salomon’s presentation, Dr. Nasrin Nabavi, Transplantation Immunobiology branch would give an overview of “The Genomics of Transplantation Cooperative Research Program” within the Division.

Dr. Rotrosen concluded his remarks by letting the subcommittee members know that members of the division’s branches and offices had participated in a number of workshops, symposiums and meetings. In addition, the division had released several scientific initiatives.

Dr. Rotrosen informed the Council members there were 3 concepts for review and approval.

The following concepts were presented for the Subcommittee’s consideration:

Stem Cell Transplantation for the Treatment of Scleroderma: This is an ongoing study called: "Randomized Open-label, Phase II Multi-Center Study of High Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+ HPC versus Intravenous Pulse Cyclophosphamide for the treatment of Severe Systemic Sclerosis.”The objective is to continue support for the existing contract to complete the ongoing clinical trial evaluating the safety, toxicity, and efficacy of stem cell transplantation for the treatment of scleroderma and the mechanism underlying this intervention. The Subcommittee unanimously approved this initiate.

Allergen Epitope Validation Resource: This initiative will support research to conduct mechanistic studies, using T cell epitope and tetramer reagents that are currently being developed under an expiring contract, to help understand human allergen-specific T cell responses in vivo. The mechanistic studies will provide phenotypic and functional characterization of the human allergen-specific T cell immune responses during the progression and/or changes in the severity of seasonal allergic diseases (e.g. allergic rhinitis, asthma triggered by seasonal allergens), and/or the changes resulting from therapeutic intervention of allergic disease (e.g., immunotherapy). The Subcommittee endorsed and unanimously approved this initiate.

Cooperative Study Group for Autoimmune Disease Prevention: The long-term goal of this program is to develop the knowledge base necessary to design interventions for the prevention of autoimmune disease that could be administered efficiently and safely to individuals at risk or to the general population, including infants and children. While such interventions might also be useful in established disease, the focus of this program is on prevention rather than therapy. For the purpose of this RFA, "prevention of autoimmune disease" is defined as halting the development of an autoimmune disease prior to clinical onset by means other than global immunosuppression. The Subcommittee unanimously approved this initiate.

V. Report of the Division of Microbiology and Infectious Diseases—Carole Heilman, Ph.D., Director

Dr. Irene Glowinski, Deputy Director of the Division of Microbiology and Infectious Diseases (DMID), chaired the September 20, 2010, NAAID Microbiology and Infectious Diseases Subcommittee meeting. After welcoming the Subcommittee, Dr. Glowinski referred to the Branch Chiefs/Acting Branch Chiefs in attendance to introduce their respective new hires.

Following welcoming remarks and introductions, Dr. Glowinski referred to program staff to present the following fiscal year 2012 concepts for the Subcommittee’s consideration and approval:

Chemical Approaches to Target Selection for Drug-Resistant Pathogens

Dr. Christine Sizemore presented this concept, which would support collaborative projects that use chemical molecules as tools to probe and understand key physiological processes in microbes and host-pathogen interactions to inform our understanding of physiology and key metabolic pathways, and identify points of interventions that can later be used in chemical screens to select drug candidates. The Subcommittee endorsed and approved this concept, which would support projects using chemical tools to contribute to functional annotation of genes and to further elucidate potential drug targets.

Genomics Program Report – Prior to the presentation of two DMID genomics concepts, Dr. Maria Giovanni, Assistant Director for Microbial Genomics and Advanced Technology in DMID, provided a brief update on programmatic activities, describing the various ‘omics resources DMID makes available to the scientific community, as well as summarizing the policies and procedures guiding their use. She also reported on the outcome of a February 2010 Genomics Blue Ribbon Panel meeting, which was assembled to assess the current DMID genomics program and provide guidance for DMID’s future genomics activities. The Panel was comprised of more than 50 leaders in genomics and infectious diseases research, and they commended DMID on the range of ‘omics services provided.

Structural Genomics Centers for Infectious Diseases

Dr. Valentina Di Francesco described the objective of this concept, which would renew the ongoing Structural Genomics Centers for Infectious Diseases. Under this program, investigators would apply state-of-the-art, high-throughput (HTP) structural biology technologies to experimentally characterize the three-dimensional atomic structure of targeted proteins from pathogens that cause infectious diseases. The Subcommittee supported the renewal of this concept. Council members inquired about the processes that will be used to prioritize protein targets entered into the structure determination pipeline, as well as the criteria that will be used to review and approve protein targets proposed by the broad scientific community. Program staff provided detailed answers in response to both questions, which satisfied the Subcommittee. The concept was unanimously approved.

Pathogen Functional Genomics Research Centers

Dr. Maureen Beanan described this concept, which is also a recompetition. The objective of this concept is to provide large scale, state-of-the-art, high-throughput functional genomics and related technologies and services to assist the infectious disease research community in functionally characterizing and analyzing pathogen genomes. Program staff noted that the renewal of this Program will focus on projects to characterize hypothetical and unknown open reading frames, micro RNA and other small RNA regions and noncoding DNA sequences. The Subcommittee voiced support for this approach, and were pleased to hear that community input and support will continue to drive the selection of projects to be conducted through the Centers. The Subcommittee unanimously approved the concept.

Biodefense Partnership Program

Dr. Michael Schaefer presented the biodefense partnership concepts for clearance by the Subcommittee, noting that the Partnerships Program is instrumental to the Institute's translational or product-focused research activities. In fiscal year 2012, DMID is proposing a new, dual approach for the long-running Partnerships program that utilizes separate funding mechanisms for early-stage activities and mid-stage product development activities. He then presented the following partnerships concepts for the Subcommittee’s consideration:

Partnerships for Biodefense – The objective of this concept is to support mid-stage development of vaccines, therapeutics, adjuvants and diagnostics against NIAID Category A-C agents. Several of the Subcommittee members had questions concerning DMID’s plan to require awardees to demonstrate substantive investment by an industrial partner, and voiced concerns that this requirement could pose a considerable burden for academic investigators. Program staff agreed to further explore how DMID might define this requirement.

Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens - This concept would support basic-to-translational research focused on development of improved diagnostic capabilities for select biodefense and emerging pathogens. The Subcommittee expressed strong support for this concept aimed at developing improved diagnostic capabilities.

Therapeutics for Neurotropic Biodefense Pathogens - This concept would support basic-to translational research focused on discovery and/or development of new therapeutics against neurotropic agents. The Subcommittee expressed strong support for this concept focused on discovery and/or development of new therapeutics against neurotropic agents.

Targeting Resistance in Select Gram-Negative Pathogens - This concept would support basic-to-translational research focused on development of antibacterial technologies designed to circumvent resistance in specific to gram-negative pathogens. The Subcommittee expressed strong support for this concept focused on the development of antibacterial technologies designed to circumvent resistance in specific gram-negative pathogens.

Host-Targeted Interventions as Therapeutics for Infectious Diseases - This concept would facilitate the design and development of anti-infective therapeutic agents that have a broad spectrum of activity and are less likely to result in the development of drug resistance. The Subcommittee expressed strong support for this concept focused on designing and developing anti-infective therapeutic agents that have a broad spectrum of activity.

In summary, the Subcommittee strongly endorsed the continuation of the DMID Partnerships Program, noting that the program has been instrumental in supporting the Institute’s research priorities. The Subcommittee expressed strong support for the plan to develop new Partnership initiatives focused on earlier-stage product development activities. In particular, the Subcommittee favored the idea of supporting short-term, milestone-driven exploratory or feasibility studies that could transition to expanded development, if deemed meritorious and. All Partnerships concepts were approved.

Combined Multipurpose Prevention Strategies for Sexual and Reproductive Health – Dr. Carolyn Deal presented this concept, designed to stimulate early and mid-stage translational research focused on the development of combined multipurpose prevention strategies for sexual and reproductive health. The Subcommittee voiced strong support for the concept. One of the Subcommittee members felt the timing was good to pursue such an approach, citing recent progress with similar approaches for malaria, and noting that even imperfect tools in combination can have a profound public health impact. The Subcommittee approved the concept.

VI. Joint Meeting of the AIDS Subcommittee, National Advisory Allergy and Infectious Diseases Council and AIDS Research Advisory Committee (ARAC)—Carl Dieffenbach, Ph.D., Director, DAIDS

Dr. Uittenbogaart welcomed ARAC members, DAIDS representatives, and guests. She presented the minutes of the May 24, 2010, ARAC meeting, and members approved them with no changes by a hand vote.

Director's Report

Carl W. Dieffenbach, Ph.D., Director, DAIDS

Dr. Dieffenbach welcomed a new ARAC ex officio member, Victoria J. Davey, Ph.D., R.N., Chief of the Veteran’s Administration Office of Public Health and Environmental Hazards. Dr. Davey replaces Ronald O. Valdiserri, who has become Deputy Assistant Secretary for Health for Infectious Diseases at the Department of Health and Human Services (DHHS). Dr. Dieffenbach thanked Drs. Dandekar, Hazuda, and Andrea Kovacs, M.D., who are rotating off the ARAC and expressed appreciation for their contributions to the committee.

Budget Update

Dr. Dieffenbach reported that the proposed FY 2011 NIAID budget, just shy of $5 billion, represents a 3.3 percent increase over the FY 2010 budget. The new budget features nearly equal attention to HIV/AIDS, biodefense and emerging diseases, and infectious and immunologic diseases. House and Senate hearings on the proposed FY 2011 budget have taken place. Both the House and Senate versions contain a $50 million allotment to support the Cures Acceleration Network, or CAN. The CAN will support research in high-priority therapeutics, biologics, and medical devices that have not attracted funding from the private sector because of the lack of commercial market. Each CAN project is eligible to receive up to $15 million. Dr. Dieffenbach reported that NIAID has received $1.1 billion in funding through the American Recovery and Reinvestment Act (ARRA). Of that amount, about 86 percent is being used to support research project grants (RPGs). By the end of FY 2010, about 1,800 awards will have been made. NIAID will begin FY 2011 by applying a conservative funding approach, with an interim payline at the 8th percentile.

Staff Update

Dr. Dieffenbach announced that Emily J. Erbelding, M.D. M.P.H., joined DAIDS as its new Deputy Director. Prior to joining DAIDS, Dr. Erbelding held a leadership position at Johns Hopkins for more than 9 years. She is a highly regarded clinician and program leader, committed to advancing public health goals. She has a successful track record in integrating HIV prevention and care research with the STD program of a large urban health department. In fact, her career has focused on advancing HIV/STD care and prevention.

Jeffrey Nadler, M.D., who had been serving as Acting Director of the DAIDS Therapeutic Research program since July 2007, has retired. Carla B. Pettinelli, M.D., Ph.D., has agreed to serve as Acting Director of the program. Patricia Baron, who has worked at DAIDS for 18 years, also retired. Ms. Baron played an essential behind-the-scenes role for the Division, and in particular always ensured that Council meetings ran smoothly.

Scientific Highlights

Dr. Dieffenbach reported on two trials. The Cambodian Early Versus Late Introduction of Antiretroviral Drugs (CAMELIA) study found that it is possible to prolong the survival of untreated HIV-infected adults with weak immune systems and newly diagnosed tuberculosis by starting anti-HIV therapy 2 weeks after beginning tuberculosis treatment (as compared to waiting 8 weeks). The trial was launched at 5 Cambodian sites in January 2006.

Results from the CAPRISA 004 study were announced at the International AIDS Society meeting. The study found that tenofovir gel used before and after sex reduced the risk of HIV infection by 39 percent. This statistically significant result established a proof of concept that the use of a topical anti-retroviral-based product can interrupt HIV transmission in women. Another finding was that the intervention led to a 51-percent reduction in HSV-2 infection in women. The trial involved uninfected at-risk women in two South African sites and was initiated in May 2007. Dr. Dieffenbach congratulated Dr. Salim Abdul Karim and the CAPRISA team for their achievement. There will be a follow-up study.

Restructuring the HIV/AIDS Clinical Trials Networks

Dr. Dieffenbach noted that the topic of planning and restructuring the HIV/AIDS clinical trials networks will be addressed in a large discussion in the latter half of this ARAC meeting. A goal of restructuring the networks is to establish a multi-disease capacity by building on the infrastructure of the HIV/AIDS network. A consultative process is underway and includes efforts to seek input from colleagues and use of an Internet blog to facilitate input and dialogue. Consultations are continuing, and a large town hall-style meeting to allow public input will be held on October 26. DAIDS staff will present a final concept for network restructuring to the ARAC and AIDS Subcommittee of Council at the February 2011 meeting.

Additional goals for restructuring the clinical trials networks include targeted scientific goals and addressing diseases including tuberculosis and hepatitis; maintenance of community involvement; increased flexibility and “rental capacity” within the network; a transparent mechanism for supporting meritorious ideas; the linking of site capacity with trial capacity; and the ability to increase efficiency and timeliness in host countries. Information about NIAID’s plans and public comments are located on the website at under “Future Directions for NIAID HIV Research: Consider and Comment.”

Concept Reviews

Consortia for AIDS Vaccine Research in Nonhuman Primates

Alan Schultz, Ph.D., Preclinical Team Leader, DAIDS

The objective this concept is to elucidate the viral and host events that occur in acute mucosal SIV infection and determine how those events can be halted or modulated by vaccine-induced responses. This is a renewal, using a U19 cooperative agreement mechanism; the duration is 5 years, with a first year cost of $5 million. There will be one award. Dr. Schultz presented the history of this initiative, which grew out of the recommendations made the NIAID HIV vaccine summit in 2008. The initiative will support a consortium of investigators to conduct collaborative multidisciplinary investigations of the viral and host events of mucosal SIV infection in macaques and the mucosal immune responses generated by SIV vaccines. ARAC reviewers, Drs. Picker and Dr. Dandekar, strongly supported the program. They believe this to be a critically important effort that brings together scientists who have expertise in mucosal immunology and vaccine research to address the complex pathobiology of early infection in a NHP model.
The reviewers did raise concern about the level of funding given the high cost of maintaining nonhuman primates and conducting NHP studies. There was agreement that focusing on one route of HIV transmission (i.e., vaginal transmission) would not be wise, as there is much to be learned from all routes of transmission and from comparing them. In response to questions, Dr. Schultz described how this initiative fits in with other NHP research supported by DAIDS.

The ARAC members expressed support for the concept, made a motion to approve it, and voted.

Innovation for HIV Vaccine Discovery (IHVD)

Geetha Bansal, Ph.D., Vaccine Discovery Branch, DAIDS

The objective of this concept is to stimulate investigator-initiated research on innovative, high risk/high impact novel vaccine approaches that might provide long-term, safe protection from acquisition of HIV. This is a new program and uses a modified R01 mechanism (preliminary data not required); the duration is up to 4 years, and the first year direct cost per grant is $350,000, with a total first year cost of $4 million. Dr. Bansal reviewed the rationale and need for innovative vaccine discovery paradigms and listed examples of types of research that will be fostered (e.g., the potential of host proteins as immunogens alone or together with HIV immunogens). Cross-disciplinary collaborations will be encouraged and investigators new to the HIV vaccine field will be encouraged.

The reviewers, Drs. Picker and Dandekar, supported the project enthusiastically, calling it timely and well justified. They felt the use of a special review panel could help to foster innovative ideas, which doesn’t happen easily in standard study sections. The reviewers did caution against restricting applications to those submitting preliminary data. In response, it was noted that preliminary data would not be required and applications without preliminary data would not be adversely affected. The reviewers also cautioned against becoming too specific on the exclusionary research, such as vector and animal model development. Toward that end, research that explores mechanisms of novel intervention strategies will be included. It was noted that when the Funding Opportunity Announcement (FOA) is written, it will be made clear that the list of possible responsive applications is illustrative and applications should not be limited to this list.

The ARAC members expressed support for the concept, made a motion to approve it, and voted.

Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID)

Stuart Shapiro, CHAVI Program Officer, DAIDS

The objective of CHAVI-ID is to support coordinated multidisciplinary efforts that cannot be accomplished with single-project grants and small groups of individuals. This is a new program and uses the U19 cooperative agreement mechanism; the duration of the award is 7 years, with a first year total cost of $31.5 million (for one or two awards). Dr. Shapiro discussed the need to identify an immunogen that induces durable, highly effective, broadly protective immune responses and the role that a large, multidisciplinary approach can play. The initiative will support a multidisciplinary team of senior researchers focused on critical questions and will encourage “big science” approaches. It will require collaboration with the HVTN and other groups and require the exchange of unpublished results with other DAIDS awardees. It will also encourage the use of new technologies from other fields. Some of the unique features of this program are that it will be a cooperative agreement to provide close coordination with other DAIDS vaccine efforts; utilize a program officer team from across the DAIDS and other NIAID Divisions vs. a single program officer; and there will be a leadership group empowered with the flexibility to change directions, technologies, project and core funding levels on a yearly basis within the scope of the award. There will be a strong management and operations core, and an infrastructure and opportunities fund, under the responsibility of the leadership group, to enable development and support of new, large projects and pilot projects, identification and evaluation of new technologies, to add new investigators, to assist early career investigators, and/or to create new cores within the scope of the award. There will also be a shared external scientific advisory board to review progress in both awards, if more than one award is made, to promote coordination and collaboration and to provide consistent advice to the DAIDS.

The ARAC reviewers, Drs. Celum, Michael, Bernstein and Picker, considered the rationale to be well aligned with the size of the award and believe that the use of a joint Scientific Advisory Board will be beneficial. They were initially concerned with early plans of having only one large award and were pleased to see that there is flexibility to consider one or two awards. They liked the balance with other DAIDS programs, balancing – encouraging funding innovation by single investigators through other mechanisms while also encouraging/funding these large teams of investigators. The FOA will make it clear that applicants can spend some money on clinical studies to collect such samples but that collaboration for this purpose is preferred. A suggestion was also made that the external supervisory board include scientists with regulatory experience.

The ARAC members expressed support for the concept, made a motion to approve it, and voted.

Next Generation PrEP

Fulvia Veronese, Ph.D., Microbicide Trials Network, DAIDS

This concept has the objectives of strengthening the pool of dedicated investigators in the area of PrEP research, creating a rational pipeline for identifying and discovering next generation PrEP, and developing a basic and preclinical algorithm for selecting and advancing PrEP candidates for clinical studies. It is a renewal and uses the R01 mechanism. The duration is 3 to 4 years, with a first year cost of $3.2 million. There will be 3–5 awards.

Dr. Veronese presented a list of ongoing and planned trials employing tenofovir and/or emtricitabine. She noted that if any of these trials show PrEP to be efficacious, the efficacy might be offset by the development of resistance and risk compensation. So the need to develop and test optimal PrEP agents remains important. The initial FOA for Next Generation PrEP was released on May 27, 2010, and applications are due November 2. Areas of research to be supported include discovery of new molecular entities and development of antiretroviral agents, development of PK/PD profiles of candidates, development of delivery systems for PrEP candidates, and development or improvement of animal models.

The ARAC reviewers, Drs. Carter and Hazuda considered the program timely and important. They suggested that the development of combinations be highlighted and that the evaluation of resistance across viral subtypes be pursued. During discussion it was questioned whether the list of ideal attributes for PrEP might discourage some investigators. In response it was noted that these are ideal properties and applicants will not be asked to come forward with agents that possess all these characteristics. The potential to pair with pharmaceutical companies to investigate molecules that they have was also mentioned. A question was raised concerning topical versus oral pipelines for PrEP and it was indicated that the initiative includes both oral and topical applications.

The ARAC members expressed support for the concept, made a motion to approve it, and voted.

Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM)

James A. Turpin, Ph.D., Topical Microbicide Team, DAIDS

This objective of the IPCP-HTM is to stimulate a strong, diverse base in preclinical discovery and development of new topical microbicides and combination strategies for vaginal, penile, and rectal use. It will support research to advance well characterized microbicide leads and strategies into clinical studies. It is a renewal and uses the U19 cooperative agreement mechanism. The duration is 4 years preclinical/5 years clinical, with a first year cost of $7 million. There will be 1–3 awards. Dr. Turpin stressed that this program will be able to move forward in a number of areas building on the results of CAPRISA 004, including: the development of new microbicides, new antiretrovirals, and new combinations and an understanding of the roles of pharmacokinetics and pharmacodynamics. The IPCP is a flagship program with seven currently active awards. The program seeks to achieve a steady state of 8 to 12 awards. The program’s current approach features a modular concept for the projects, which may include animal efficacy studies, behavioral studies, an IND-enabling project, and pre-Phase-I clinical studies.

The ARAC reviewers, Drs. Carter and Hazuda felt that the program is timely and comprehensive, addressing an important need. They encouraged the program to increase its emphasis on developing biomedical adherence methods and measures.

In discussion, there was a question about funding from other NIH Institutes. It was noted that NIMH will provide funds for studies that it wants to pursue. Other institutes have also been approached but with limited funds, it’s difficult to garner support. There was also a discussion of the behavioral component of the program, which was described using formulation and acceptability as an example. In this case women were asked to express their acceptability, their feelings about how it feels, what it smells like, how it tastes, not only from handling but also from coitus.

The ARAC members expressed support for the concept, made a motion to approve it, and voted.

Centers for AIDS Research (CFAR)

Diana Finzi, Ph.D., M.P.H., Basic Sciences Program, DAIDS

This concept is for the renewal of the CFAR, which supports a multidisciplinary collaborative environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. The CFAR serves to accelerate the pace of AIDS research in institutions; it uses the P30 mechanism, and the duration is 5 years. The first year cost is $42.2 million, with 6 other institutes joining NIAID in covering that cost. Dr. Finzi presented background on the CFAR program, established in 1988, and described the many activities inside and outside the United States and the program’s numerous accomplishments. The individual programs feature an administrative core, a developmental core, basic science core(s), and clinical cores. The ARAC reviewers, Drs. Uittenbogaart and Goodenow stated that the program is unique in the way it provides support to HIV researchers. Its broad research scope and local control are advantages. The reviewers welcomed the recent financial contribution from the Institute on Aging. In discussion, it was suggested that the program emphasize more clinical and translational research. There was agreement that the CFAR has a positive impact in fostering collaboration and coordination of research.

The ARAC members expressed support for the concept, made a motion to approve it, and voted.

Restructuring the HIV/AIDS Clinical Trials Networks

Background and Governance

Carl W. Dieffenbach, Ph.D., Director, DAIDS

As context for restructuring the networks, Dr. Dieffenbach noted that in June 2009, Dr. Fauci stated the Institute’s intention to have the HIV/AIDS clinical trials networks implement clinical trials for tuberculosis and other infectious diseases. Dr. Dieffenbach mentioned the release of the National HIV/AIDS Strategy by the White House, which emphasizes bringing the federal partners together to really tackle the US epidemic. He noted the goal of putting effective treatment strategies for hepatitis and other infectious diseases to use in reduce HIV incidence domestically and the desire to increase access to care and optimize health outcomes, and reduce health care disparities. It is hoped that by restructuring our HIV/AIDS clinical trials networks, NIAID will provide the research foundation for the National HIV/AIDS Strategy.

Given that the awards for NIAID’s six HIV/AIDS Network Leadership Groups are scheduled to expire in 2013, and the awards for the Clinical Trial Units (CTUs) and clinical research sites are scheduled to expire in 2014, there is an opportunity to expand the scope of research and increase flexibility. Specifically, the goals for restructured networks include: multi-disease research capacity, targeted scientific goals, community involvement, operational flexibility, transparent mechanisms for supporting meritorious ideas, site capacities linked to trials, and an ability to work with host countries to improve efficiency and timeliness. Dr. Dieffenbach described current governance relationships of the networks and noted that the system works reasonably well.

In restructuring, it is anticipated that the number of CTUs will be reduced to about 25 while expanding the number of research sites related to each and expanding responsibilities and surge capacities. The proposed governance features three levels—a more standardized strategic working group, an operational working group, and the Office of HIV/AIDS Network Coordination. The plan is to make the new Leadership Group awards in January 2013 and make the new CTU awards in May 2014.

HIV Vaccine Research

Alan Fix, M.D., Vaccine Clinical Research Branch, DAIDS

The primary objective of a new HIV vaccine research network would be to establish a comprehensive clinical research program to discover and develop an efficacious prophylactic HIV vaccine. Some of the priorities of a future vaccine network will include:

  • Designing and conducting Phase I, II, and III trials, including novel designs that reveal efficaciousness
  • Assessing B-cell, T-cell, and mucosal innate responses
  • Analyzing correlates in Phase IIb and III trials
  • Studying behavioral and social aspects in prevention and transmission
  • Integrating clinical and basic nonhuman primate agendas.

As we move forward, it will be important for site investigators to continue to provide input, including input into the scientific agenda of the network. We also want to expand to include expertise from outside of the network, including from non-HIV researchers. Continued collaborative work with our partners and the community will remain an essential goal. Potential partners will include other NIAID divisions, NIH institutes and centers, government agencies, communities, industry, nongovernmental organizations, and other research networks. By 2020, there should be substantial progress toward an HIV vaccine, greater understanding of the results of RV 144, Phase 2b studies to extend RV 144 findings, better measures of the immune response, assessment of vaccines in combination with other modalities, and the use of the HIV trials capacity to support studies of vaccines for tuberculosis and hepatitis.

HIV Prevention Research

Sheryl Zwerski, R.N., Prevention Sciences Program

A prevention trials network would have the objective of integrating biomedical and behavioral prevention strategies to reduce HIV incidence. Scientific priorities include the following:

  • Testing and bringing to licensure microbicides for vaginal and rectal use
  • Testing PrEP agents singly and in combination
  • Evaluating emerging products
  • Testing HIV treatment used as prevention
  • Finding novel approaches to IDU treatment to prevent HIV acquisition
  • Studying HIV testing and links to strategies that reduce transmission and acquisition
  • Developing and testing integrated biomedical and behavioral prevention strategies to reduce incidence on a population level.

Ms. Zwerski encouraged the creation of a single prevention network to manage all aspects of HIV prevention clinical trials. It will be important to retain successful aspects of prevention trial development and conduct, the participation of international investigators, and significant partnerships inside and outside the NIH (including many of the partnerships that are currently in place). There will be a need to prioritize and manage resources within all areas of HIV prevention. By 2020, the new network could complete Phase III trials of new formulations and matrices for intravaginal rings and films for microbicides. By then we might see the completion of Phase III trials of rectal microbicides and Phase II trials of next generation PrEP agents. Other possibilities include Phase IIb/III trials of topical microbicides, combination prevention trials, and studies of international enhanced testing linked to care and treatment.

HIV Treatment Research

Carla B. Pettinelli, M.D., Ph.D., Therapeutics Research Program

The future therapeutic clinical trials research network which encompass four scientific priority areas:

  • Cure or functional cure for HIV
  • Tuberculosis
  • Infectious hepatitis
  • Non-infectious co-morbidities and novel interventions for HIV-infected persons.

Scientific partnerships will be needed for all research areas, and in particular for infectious diseases, cardiovascular disease, neurological complications, behavioral aspects, metabolic complications (including bone disease), aging, and malignancies. Dr. Pettinelli listed potential partners inside and outside the NIH and stressed emphasized the key leadership goals of ensuring network capacity, flexibility, and responsiveness to high-priority research questions. The network should retain the current highly dedicated investigators, international investigators, collaborations with various institutions, state-of-the art laboratories, and structures for data management. By 2020, the networks should attain progress beyond proof-of-concept for a cure strategy; achieve reliable, affordable point-of-care diagnostics; be able to evaluate long-acting antiretroviral interventions; identify better hepatitis treatment regimens, and establish improved management and care for major co-morbidities and co-infections.

HIV Pediatric Research

Ed Handelsman, M.D., Pediatric Medicine Branch, DAIDS

A pediatric and maternal research network that would address the following priority areas:

  • High priority vaccines
  • Cure or functional cure for HIV/AIDS
  • Co-infections, co-morbidities, and ART consequences
  • Prevention of acquisition
  • Pharmacology and drug formulation.

Dr. Handelsman further described these priorities and listed the following areas for scientific partnerships: biomedical HIV prevention modalities, growth and development, behavioral and neuro-developmental complications, metabolic complications (including bone disease), and high-priority infectious diseases. Potential partners from inside and outside the NIH were noted and an emphasis was placed on broadening research to include other infectious diseases, collaborating with investigators outside the network, and improving the efficiency of protocol development and implementation. It will be important to retain the integration of international investigators in network leadership roles, collaborations with other networks and institutions, and contributions of laboratory, data management, and operational entities. By 2020, the network should develop new therapeutic vaccines, move beyond the proof-of-concept for cure strategy, identify better management and standards of care for co-morbidities, bridge studies of microbicides and PrEP for adolescents, and establish optimal safety and dosing of antiretrovirals for children and pregnant women.

Clinical Trial Units and Clinical Research Sites

Manizhe Payton, Office of Clinical Site Oversight, DAIDS

An important goal of restructuring the networks is to develop a rational system for sites that feature robustness, flexibility, and strong research capacity. Sites should be able to respond quickly to NIAID and Network research priorities, focus on efficiencies, encourage cost containment, and contribute to the network scientific agenda. Priorities for the CTUs will include multi-scope capability across multiple Networks, with partners such as sister divisions, other ICs, or other USG agencies, greater science contribution to Network’s scientific agenda, ability to address non-HIV work, and increased flexibility with a mechanism for expansion and contraction of protocol specific sites. The CTU structure will be strengthened, with increased responsibility and accountability for performance of and capacity assessment of clinical activities. DAIDS is committed to supporting capacity at our international research sites, and plans to continue stable funding through core CTU awards. The existing authoritative relationship between CTUs, Network, and NIAID could be strengthened by the introduction of consortium agreements between the Networks and CTU and Network and Sites that will give the Networks reach-through authority to the sites. Goals to be achieved between 2013 and 2020 should include aligning CTU capacities and expertise in light of scientific priorities, establishing mechanisms for the use of resources (with cost containment), clarifying roles and responsibilities, and establishing a scientific enterprise that contributes to the agenda (in and out of the network).

ARAC members discussed the use of incentives to encourage scientific contributions from site leaders and the proposed reduction in the number of CTUs. Dr. Dieffenbach added that the number of sites may also be reduced. Members encouraged DAIDS to consider the successes of specific sites when it plans reduction and noted the difficulty of predicting capacity for potential trials. The possibility of leverage activities, for example, through a “rent-a-site” capability and a mechanism for bringing on short-term temporary sites were raised. Oversight by network leadership will be important.

Discussion and Public Comment


ARAC members discussed regulatory issues and the difficulty of attaining efficiency in the regulatory review process with other governments. Dr. Dieffenbach noted that investigators who are in leadership positions in those host countries can sometimes help to begin conversations about regulatory review.

The issue of product development for microbicide was also discussed and the importance of bringing all interested parties to the table to develop strategies was noted. Dr. Dieffenbach also stressed the goal of addressing the key priorities rather than creating fiefdoms of interest or activity. The potential for tension between vaccine research and research in other prevention modalities was raised.

The difficulty containing costs was questioned and Dr. Payton suggested that one containment strategy might be to focus on core costs, adjusting core funding based on performance. Dr. Dieffenbach stated that network leadership should choose the best science, whether from inside or outside the network.

Sharon Maxwell, of the Coalition on HIV and Aging Research and Policy Advocacy (CHARPA), urged DAIDS to focus on older HIV-infected adults and asked if there could be an Office on HIV and Aging. Dr. Dieffenbach suggested that the networks help could help integrate research related to aging and HIV. Dr. Lawrence Corey, of the Fred Hutchinson Cancer Research Center, questioned whether there was an overall strategic plan for the Institute that addressed the extension of research activities to non-HIV and related collaborations.

Public Statements

Members of the public presented the following statements.

Chris Thomas, CHARPA: Thank you. Good afternoon. My name is Chris Thomas, and I am an individual living with HIV and AIDS for over half of my life. I’ve also been taking antiretroviral therapies for 15 years, every day for 15 years. I’m a member of the CHARPA, which is the Coalition for HIV and Aging Research and Policy Advocacy.

CHARPA was formed earlier this year to call attention to the many complications and co-morbidities faced by the aging population of HIV-positive people in the United States, a rapidly growing, medical crisis that has been woefully neglected by the US research efforts. Although increasing evidence points to an earlier onset of age-related conditions in people living with HIV, little is known about the pathogenesis or proper methods to screen for, prevent, and manage these conditions, or anticipate the infrastructure needed to deliver care and treatment for people suffering from these conditions.

We are extremely concerned that NIAID’s current research priorities underplay the potential long-term health impact of disregulated T-cell homeostasis in people with HIV, which in many cases is not addressed by antiretroviral medical viral suppression. We expect an increase in morbidity and mortality for people living with long-term HIV, particularly those who start antiretroviral therapy with the CD4 nadir below the threshold at which initiation of antiretroviral therapy is recommended, which includes almost everybody in resource-poor settings and people with additional risk factors, regardless of chronological age.

The complex interactions between HIV infection, premature aging, immune disregulation, long-term drug toxicities, co-infections, and comorbidities in various organ systems pose an unprecedented research challenge. We urge NIAID to take on this challenge in the network restructuring process by

  • Identifying HIV and aging as a new and distinct future HIV-aging therapeutics research priority.
  • To establish one or more large-scale, well-characterized longitudinal cohort of people with HIV with matching HIV-negative controls and seek out innovative approaches to assess HIV and aging-related issues within existing clinical trial networks, existing cohorts, collaborative groups, and Phase IV post-marketing trials to help develop and standardize biomarkers and characterize relevant AIDS and aging events.
  • Create a new aging working group within ACTG, similar to the one created for lipodystrophy (ph) more than a decade ago, to spur new studies on badly needed interventions and preventive measures for aging-related complications.
  • Ensure cohorts of perinatally-infected children are support to investigate the incidence of, and risk factors for aging-associated diseases.
  • Furthermore, mandate coordination with ACTG and INSIGHT networks to study therapeutic and preventive interventions in this unique population.
  • Lastly, we call on NIAID, along with other institutes and centers, in collaboration with the Office of AIDS Research to immediately commit significant financial and organizational resources to develop a detailed and long-term research plan on HIV and aging. We insist on full and immediate community participation in all stages of planning for this research, utilizing the experience, knowledge and commitment of HIV-AIDS community activists. Thank you.

Sharon Maxwell, CHARPA: I would like see an HIV/aging cohort help to develop a scientific agenda.

Brooks Jackson, IMPAACT/Johns Hopkins: As a network leader, I think one of the biggest challenges we face is the number of sites not utilizing their capacity despite their populations. A lot of this deals with regulatory issues in-country, although, for some of it, the local PI has clout and can make a difference. I like hearing about putting more accountability in the site to do something as opposed to being passive. What can I do when the IRB is taking more than a year to review a protocol? Having the NIAID provide some sort of liaison with the ministry of health through the embassy would really help tremendously. We have very large sites just sitting there, with large protocols, and we just can’t get past the regulatory issues. Regarding funding to the sites, being able to send some money directly from the network to the sites (although grants management is very busy) would be helpful. We need more core funding for stability in the bigger sites, if the protocols can be advanced in a timely fashion and large numbers can be kept enrolled. I don’t understand the challenges of surge capacity, having nurses experienced with a type of protocol—this will always be a challenge. Big sites have lots of different capacities.

Sharon Hillier, MTN/University of Pittsburgh: Thank you for a lot of things today that I liked, in terms of the governance proposals and increased efficiency and capacity to link performance with output from clinical trial sites. That has been one of our major frustrations. It won’t be a huge surprise to people in the room that the PI for the microbicides trials network doesn’t necessarily think that having a single network devoted to all prevention is the best possible approach. Many people know that the microbicide development field was born within the HPTN in 2006. With the recent success of CAPRISA and a robust agenda in the field of microbicides and PrEP, we’ve seen the limits and expansion of our programs become more important. We left the HPTN because we believed we could do our work more efficiently within a more focused timeline-driven drug development paradigm. We remain unconvinced that condensation of all of our activities, even with strong leadership, to include behavioral research, treatment as prevention, and more, would be less difficult. There would be a significant risk of dilution in efficiency moving ahead. I want to put on the table a question: When the network RFA is written, will it permit two prevention networks, or will it specifically say there has to be a single prevention network?

—It was noted in response that NIAID is still considering the various possibilities and taking all these factors into consideration.

Dr. Corey, HVTN/Fred Hutchinson Cancer Research Center: Actually my comment relates not to the clinical trials network, but to the comment I tried to make this morning, about the RFA for innovation in HIV vaccines. I’m obviously very supportive of, but I also just wanted to highlight that I think it’s a very important RFA for the institute and it needs to be looked at from the total dollar figure because what is occurring is a marked change in the CAVD program from the Gates Foundation. And there’s a significant shift, as least my reading of that newest RFA, away from design and into development. And therefore the institute really is picking up a larger load, essentially worldwide, of HIV vaccine design.

And taking a look at the portfolio, and sort of making sure that some of the groups which really have significant number of young investigators tied to them that are working in this field, is really something that the institute really, whether it’s fortunately or unfortunately, in my opinion, unfortunately, is going to have to pick up. And so this award is really an important one. The total dollar figure, I think, really needs to be looked at as well as some of the HIVRAD dollar figures, because of -- and some policy issues with trying to integrate with what the new RFA from the Gates Foundation is saying.

Don MacIver, Global Community Advisory Board and the NYU CAB: NYU serves four networks. The presentations in today’s meeting were outstanding. (1) Regarding the issue of aging, the VA, in the 1990s, decided to computerize medical records. It therefore has tons of observational data and could study any issue. It has an aging cohort and a quality enhancement research initiative, which looks at quality of life issues. It is possible to look at aging in this population, bringing together all the information. (2) Some therapeutic vaccines exist. In Vienna, a presentation described a transdermal patch that is being tested. Perhaps NIAID could support such efforts. (3) NYU will host a presentation within the next week dealing with PrEP. We have to realize that PrEP strategies will have to deal with the differences in people. The different populations mean that we must not apply blanket treatments. (4) At the June meeting, Dr. Fauci talked about test and treat. I think that if you draw a circle and you put prevent at the top, test on one side, treat at the bottom, and adhere, and keep going in that circle: prevent, test, treat, adhere, prevent, test, treat, adhere -- you have to have a four-pronged project. You can treat them, but if they’re not adhering, you’re not going to prevent. (5) And then the last thing is, on IMPAACT, what a wonderful presentation that was, and I know they had an adolescent trials network, but I don’t know if that’s going to be put aside or whatever with this new name, but I love the name IMPAACT -- International maternal/pediatric adolescent AIDS clinical trials. He kept saying the word adolescent in his presentation, but you take the word adolescent out, you’ve got teens, you’ve got tweens, and you’ve got early 20’s, and they’re all considered adolescents, and just put the word adolescent back in your title. Thank you very much.

Samantha Kuryla, IMPAACT: Thank you for that note on IMPAACT. So my comment today is actually a compliment. And prior to this meeting we had a lot of comments to make, but I wanted to thank Dr. Fauci and Dr. Dieffenbach for allowing the IMPAACT community to come to a meeting with just a few of us, because we tend to come with hundreds of women and children and take over your neighborhoods and your buildings and make all kinds of noise to be heard.

In June, at our meeting you sort of laid this out to us a little bit, and we almost missed it, and we were very excited about what it was that we were doing at the meeting and when we finally grasped it, we were immediately concerned, and right away you had a clear transparency about the ability for people to come and be heard. And so Dr. Jackson, from the leadership of IMPAACT, and the science in relation of women, children, youth and adolescents and maternal health was heard.

So my compliment is two-fold. One is an emotional compliment. I happen to be a mother of a perinatally-infected child who, in ’96 when he was born, I was told that he would not make it past the age of five. In October of this year, he will be 14, and so the compliment is that you said often, if it’s not broke, don’t fix it, you know, and it has worked very well.

On the other emotional part, is that as a positive mom, I just want to say I am so proud to be an HIV-positive person, to sit in a room full of people who genuinely are concerned and give us an opportunity to not throw our couches in the middle of the street any more to be heard, but quietly come forth and be able to say that we are looking forward to the structure and the restructuring, whatever it is that needs to be done, in order to help people who will continue to become infected, those of us who are already infected, and those of us who are at risk of death with the elderly, to continue to know that there is hope in this process overall, so it’s an overall compliment in three different ways from me. Thanks.

David Pearl, IMPAACT: I am associated with IMPAACT. And I think it is imperative that we do not separate the two groups because if you put them together, you will lose the women and children and pregnant women in the shuffle, and I am very afraid of that happening. Thank you.

Ward Cates, HPTN, MTN: I’m actually on the executive committee of the current HPTN and MTN, and formally was chair of the old HPTN that spun off these two groups that are now being put back together, although IMPAACT was out. And I really wanted to respond to several things that I heard while listening today, which was fascinating.

Caprisa 004 has changed the dialogue, even in the basic sciences. That was really fun to hear Jim and Fulvia and others talk about how they’re building on that success, and I wanted to underscore to DAIDS, but also to ARAC that the key role of the VOICE trial and the whole MTN portfolio, as an essential underpinning of the Tenofovir gel’s development portfolio. This was not an accident. This was the product of a very carefully constructed, topical prep, in my favorite terms, portfolio that now has the Tenofovir gel portfolio way ahead.

Second, on behalf of the leadership of the HPTN that couldn’t be here, to emphasize that we strongly support the continuation of the separate MTN to fulfill its vision of delivering a topical prep agent for women and men. And because of the MTN, it’s further along, and because of the vision. Actually it was to Peggy, to some extent, to create that particular entity.

Third, I want to really applaud what has happened within the current HPTN and its domestic and global pioneering trials. Talk about flexibility, and talk about able to set priorities and respond to changing prevention priorities, the creative designs that have already has test-link care for high-risk women and MSM designs, innovative designs for IDU treatment, intermittent PrEP, and conditional cash transfers for young women. And it’s really embraced this burgeoning implementation science agenda, which is really addressing the responsibility gap that Dr. Fauci talks about. And it’s taking leadership in that area that really needs a separate, focused agenda and network in order to do.

And fourth, on a personal note, for collaboration, I am on the executive committee bridge between the HPTN and the MTN, and the degree of collaboration among the people in these two groups who, while crafting their own agendas, do communicate across the other group, not only at the scientific leadership area, but at the areas of the operational management of sites, sharing of different activities -- that is already happening while we have two networks, and it’s getting better all the time.

So I really want to put in an emphasis that the HPTN does support, for all the reasons that Sharon pointed out, the continuation of this development network for topical PrEP to give us a real hope that by 2020, that we will meet the objectives that Sheryl put on her last slide.

VII. Adjournment

The meeting of the Council was adjourned at 5:30 p.m., on Monday, September 20, 2010.

We do hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.



Anthony S. Fauci, M.D.

Chair, National Advisory Allergy and Infectious Diseases Council

Director, National Institute of Allergy and Infectious Diseases


Marvin R. Kalt, Ph.D.

Executive Secretary

National Advisory Allergy and Infectious Diseases Council

Director, Division of Extramural Activities

National Institute of Allergy and Infectious Diseases


These minutes will be formally considered by the Council at its next meeting; any corrections or notations will be incorporated in the minutes of that meeting.

Last Updated August 05, 2013

Last Reviewed August 05, 2013