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Restructuring NIAID’s HIV/AIDS Clinical Trials Networks

NIAID

Over the next several weeks, the National Institute of Allergy and Infectious Diseases (NIAID) will post a series of entries here on AIDS.gov related to planning for the future of NIAID’s HIV/AIDS clinical trial networks. The awards supporting the six current HIV/AIDS networks are set to expire in 2013 and 2014.

Building on the success of the current infrastructure, NIAID is looking to expand the scope of the network’s current activities to include the treatment and prevention of other infectious diseases of significance to people who are infected with HIV or are at risk for infection both domestically and globally, namely tuberculosis, hepatitis, and malaria. Additionally, we are looking for ways to increase collaboration across the networks, create transparent mechanisms for network leadership to solicit and support ideas from the research community, and develop a means for external researchers to tap into the clinical trial infrastructure and capacity that the network system provides. Finally, it is our goal to have each of the networks establish a means of designing and implementing a cross-network agenda to address research questions related to specific populations.

Each of our upcoming blog posts will focus on specific aspects of the network restructuring in which we are seeking input from the broader research and HIV/AIDS communities. Specifically, the entries will address:

  • NIAID’s clinical research priority areas, namely prevention, therapeutics and vaccines;
  • the structure of the new networks; and
  • the relationship between network leadership groups and clinical research sites.

Read the transcript

We will be asking specific questions designed to invite thoughtful comment that will help shape the clinical trial networks from 2013 through 2020. In order to comment, you will need to provide your name, affiliation and e-mail address, so we have a record of who has responded. However, we want people to freely express their ideas and opinions in response the questions we pose. NIAID will respond to specific comments, where appropriate, and reserves the right to exclude inappropriate comments (e.g., vulgar language, personal attacks, offensive terms that target specific individuals or groups, comments that are clearly off-topic or that promote services or products, and comments that make unsupported accusations). We will review and post comments Monday through Friday from 8:30 a.m. and 5:00 p.m. Eastern Time.

Please check back here next week, when I will be discussing prevention research and its many components, including clinical product development for microbicides, approaches to preventing acquisition and transmission, and integrated prevention strategies, including treatment as prevention.

This is an exciting time for NIAID and the future of our clinical trial networks. We hope you’ll join in the conversation to move us forward.

Comments

  1. Carole McArthur M.D.,Ph,.D says:

    I appreciated Dr Dieffenbach’s comments.
    I think we need to engage those who have worked in the field for extended periods, those who really know and have succeeded in getting things done in this challenging field (not those who are sitting in the beltway as you so correctly point out). Great impact could be achieved by directing significant energy towards TB control since this is a major co-morbidity and Malaria which we already know a lot about. If we impact TB, we automatically impact HIV! We can have all the drugs in the world for HIV but patients will still die of TB.
    I have seen a huge focus on anglophone African countries with a dearth of attention given to Francophone countries…..as an American this is both striking and puzzling to me.

  2. As a clinical research scientist, I look forward to reading the blogs and participating in the discussion. Your outreach is a positive step moving forward. The AIDS research community will welcome this initiative. Thank you.

  3. Salim S. Abdool Karim says:

    Congratulations on this open and transparent approach. In many ways, this is an opportune time to have a discussion on the future of the HIV clinical trials networks which have made and continue to make major scientific contributions to HIV prevention and treatment and could be doing the same for related epidemics such as TB.
    In particular, the Networks are strategically placed to take up the “big science” questions which need large human clinical trials. Creating a structure and organisation to match the upcoming and projected needs in the field will need bold initiative and imagination to visualize a future where the networks maintain and advance their pre-eminent role.
    Slim

  4. Janice Hand says:

    I am pleased to see that NIAID has chosen such an open forum for comment, not just by the researchers but by the real people who will either live or die based on the research findings that are ultimately translated into real treatment in the future. Surely, while the “lay” person may not have the knowledge of the nuances of research architecture, these are the people who will be asked to agree to participate as subjects. They need to be the PRIMARY focus and concern of NIAID. While I have great respect for the researchers who will one day find the both the best treatments and the cure for HIV infection, I equally respect the people brave enough to participate in clinical trials that may not have a single positive impact on them and may, in fact, do nothing at all for them. Thank you, NIAID, for openly endorsing a more transparent process. Let’s hope this is only the beginning of even greater openness in the future.

  5. Orlando Roman says:

    Hello Dr C. Dieffenbach & NIAID Group:
    I am presently the Community Representative to the ACTG/Hepatitis Committee and below are specific suggestions to your blog and presentation to the Network. Please read. I feel most can be transposted as improvements to all the Research Networks. I would love to further discuss these and other suggestions with you and your staff.
    Wish List, Positive Inputs & Suggestions:
    1. From initiation of protocols to its implementation, turn-around times not be lengthened in any way, be it in NIAID, ACTG or any other networks’ studies, especially in Limited Resources Settings (LRS). What is the present time frame from initiation, to implementation, to publishing of results? NIH/NIAID knows this time frame for each network and for NIAID itself. Shorten this time frame successfully, with the input from all concerned parties (including industry).
    2. Request an increased in the number of protocols submitted from LRS investigators as comparable to their US counterparts.
    3. Promote and allow all Institutional Centers (IC), Networks (for example, AIDS Malignancies Consortium (AMC) and International Cohorts to submit protocols/trials that could be jointly run within the ACTG and with ACTG investigators.
    4. During the Scientific Retreat, the idea of forming controls using HIV- individuals with CVD and Cancers) in future immuno-senescence trials was discussed. The ACTG should promote the creation of these trials. ViraHep-C is a NIH/NIDDK created cohort which uses African Americans and Causausian HCV mono-infected individuals, Who works together on this very important issue to the community?
    4. Results can also be measured in many ways, like how many institutions you work with and/or in how many ways, look at this list of cohorts used within NA-ACORD. ACTG already constructs protocols using outside funding sources (ie NIMH, etc.) but are these ACTG investigator driven protocols/trials developed with staff from the funding ICs? and do they share publishing rights?
    4. Preclinicals should be pre-assessed prior to entry into networks, (preferably by some other entity), an investigator’s handbook should already be constructed prior to submission of the protocols and a agreement with industry source of the sustainability of resources till the trials’ end, all done way before the ACTG sees the trials. More preclinicals need to enter the networks, either from Division of AIDS – Small Business High Priority Areas of Interest, SBIR/STTR. look at who is addresssed “(narrative descriptions of the programs and research topics (in PDF – 1.60 MB and MS Word – 1.4 MB formats)”
    5. Connections of networks’ results should be placed within the FDA safety databases, FAERS, or EU ALERT Project.
    7. The ACTG Network should again request for funds for an International ALLRT, the present ALLRT Cohort include US individuals only.
    6. With strong regards to the investigator’s interests and fulfilling our communities concerns we should never lose sight, making the networks’ attractive to industry would also be extremely helpful. Push research, but don’t fear change.
    Why aren’t the larger pharmas with preclinicals not helping out with the ACTG?
    I’ve never been shy to make comments but never without adding constructive suggestions.
    Yours truly,
    Orlando Roman
    Chair Cornell CAB
    14 East 28th Street
    New York, NY 10016
    917-286-0479

  6. The Lancet, one of the most influential medical journals in the world, has devoted its June 5, 2010, issue to the importance of maintaining and treating the mother-child unit for the benefit of global society. Against this strong support of mothers and children it appears strange that NIAID DAIDS is considering the dismantling of the most successful maternal-pediatric clinical trials network ever organized. The International Maternal Pediatric Adolescent Clinical Trials (IMPAACT) Group and previously the Pediatric AIDS Clinical Trials Group have had a mother-child health focus for over 20 years and has now expanded worldwide. These centers of excellence, originally for HIV infection, are ready to enlarge their spectrum of treatments to malaria, tuberculosis, and hepatitis. The recent statements from NIAID DAIDS would remove the special bonds that link these centers together and would spread investigators across several clinical trial networks, thus relegating mothers and children to that “invisible” status so well described by Lancet Editor, Richard Horton, in an editorial to the June 5, 2010 issue.
    NIAID DAIDS has produced a powerful and productive IMPAACT organization for mothers and children. Dismembering that organization to create a presumed more efficient and greater centralized clinical trials organization will remove that special status of mothers and children, so necessary for the future of the world.

  7. Debbie Sierra says:

    Hello my name is Debbie Sierra, I am HIV positive and I also am a parent to children that are HIV positive. I am concerned with this plan to Restructure the HIV/AIDS Clinical Trials. I am a strong believer that without children bases trials our children will not get the up-to date treatment the need to live a long life. We have to remember our children are the future, they are the next generation. Without proper treatment who knows how this will affect them.
    I believe research trials should continue to be done in pregnant woman and small children. Without this key research being done we will not know long the term affects of medications on our children or how their quality of live may be affected. Too little is known about treating children or how this cuts into there lifespan. Children are being treated with medications originally made to treat adults, this isn’t good enough. Doctors need to be able to treat these children with the proper medication strength not just guess based on the little research trails that have been done. So much research needs to be done so doctors can provide a better quality of life for our children.
    Thank you for taking teh time to read my post, I will reposting this one of my own pages, I hope to hear back form you soon.

  8. I have read with interest all the comments posted and I, too, applaud the transparency and openness of this discussion. Expansion of the networks to include focus on tuberculosis and malaria, both of which dramatically impact morbidity in HIV+ patients, is crucial but I must insist that continued funding of the perinatal networks is absolutely vital. With due respect to scientific input, I think the comments of Ms. Sierra, as someone both living with HIV and with children living with HIV, are most compelling. I have had the privilege of working in Maternal and Pediatric HIV/AIDS research as a member of a dedicated and compassionate IMPAACT/PACTG site team since 1995. I have witnessed the miraculous results that this research has had on perinatal transmission of HIV, as well as the dramatic improvements in health and longevity of mothers and children. We are still seeing increasing numbers of HIV+ pregnant women, a trend which, sadly, is likely to continue. In addition, our aging population of perinatally infected adolescents is exhibiting psychiatric, cardiac, renal and other unforeseen diagnoses, including strokes. This is a unique population that has never been seen before in history, and it demands close follow-up and care. Although perinatal HIV transmission has been virtually eradicated domestically, internationally it continues unchecked in many regions of the world. The lessons we have learned, and continue to learn, are of global significance. It is imperative that this vulnerable population continue to be funded under the restructuring NIAID is currently considering.

  9. As a former research biologist, I like to keep in the loop and am looking forward to keeping abreast of this pertinent discussion as it unfolds. Ms. Sierra, I am cheering you on and applaud your efforts in advocating for yourself and your children. You are providing an important voice to this panel.

  10. Ian Maki says:

    I, too, applaud DAIDS and you specifically, Dr. Dieffenbach, for opening this dialogue and following through with conversations in many of the diverse research settings and to the many people who have joined in this discussion. 25 years into this pandemic I am buoyed by the continued persistence of NIH-funded researchers and trial participants to discover and test novel prevention strategies and treatments.
    That said, and in recognition of the landmark achievements in HIV treatment(in developed countries) and a list of approved antivirals in the dozens in many classes, I risk the ire of other HIV+ people and patient advocates (I am HIV+ myself) by suggesting that a new emphasis be brought to bear on what King Holmes dubbs “Highly-active HIV Prevention”: expanded detection and immediate treatment for HIV+ people(TLC+), clinical prevention strategies at all levels (individual-community) that include microbicides, PrEP, PEP, TLC+, circumcision, and VACCINES. (Don’t worry, be HAH-P!)
    We have learned much through behavioral interventions, with the hardest lesson of all being that behavioral interventions cannot outpace new infections. Without multiple, accessible, clinical prevention interventions, I just don’t see incidence rates tipping downward; the low-hanging fruit has been plucked. Save systemically eliminating the social determinants of HIV infection, vaccines, microbicides, and prophylactic use of antiretrovirals are our best hopes. I cast my lot with vaccines, which have always been the most cost-effective over time.
    Look at the infrastructure the past 20 years of funding has wrought, and protect and enhance the HVTN. For years the HVTN has been encouraging and concentrating the best vaccine research within its sites, for which they should be rewarded. Invigorate funding streams by encouraging population-specific collaborations among networks, like viral hepatitis and HIV domestically, HIV and TB & malaria internationally. Blow the doors off young-scientist funding for vaccine and basic science within the network.
    Finally, we need NIH-DAIDS leadership to recognize the importance of community education strategies to raise awareness and health literacy in communities where research takes place. Create structures to link research institutions (e.g.: Fenway Institute and the Fred Hutchinson Cancer Research Center)to communities by developing community education activities in schools and businesses. As our kids’ capacity to adapt and use new technologies increases, their scientific literacy does not. Fund our research institutions to fill the gap left by underfunded science education in schools. Following the example of HRSA-funded workforce development programs (like Youth Health Service Corps and HCOP) we should fund outreach and community education activities at the level of sites, many of which have committed, expert and existing community education staff and all of which possess genial researchers, to provide communities with educational programs that explain and educate around the broadest efforts of DAIDS to end HIV, rather than specific trial-related community education strategies, for which funding comes only through the protocols. Just as we are coming to understand that “All politics is local.” we need to teach our communities that “All scientific research is local.” Community needs to learn that in order to support the work of DAIDS. We need to teach them.
    Thank you for this opportunity to share my views.

  11. Tom Hemmingsen says:

    Dear Dr. Dieffenbach,
    When an important pathogenic mechanism of HIV is proven, no matter how small the clinical study is (Yamamoto, 2002, USPHS grant# AI-32140), PLEASE follow-up on it. Especially if that study produced cures!
    Yamamoto et al, with the help of partial funding from the United States Public Health Service (USPHS), found an inexpensive cure for early HIV infections, in young, healthy HIV+ people. His Japanese teams cured their first 15 patients in 2002. A full paper was finally published in early 2009. But, conference reports (abstracts) were published many years earlier (2006). And the folks at the USPHS, who administered his grant (# AI-32140) should have known much earlier.
    Yamamoto et al have cured an additional 24 young, healthy, recently HIV-infected Japanese patients, as reported in an early 2009 FOCIS conference abstract.
    At the International AIDS Conference 2010, a new team member, Professor Marco Ruggiero, presented a poster/paper on an Italian collaboration with Dr. Nobuto Yamamoto on the genetic aspects of how natural human GcMAF helps cure an HIV infection in young, healthy, recently HIV-infected individuals. Their goal was to identify genetic differences between responders and non-responders.
    The world needs a leader who recognizes the difference between a treatment and a cure, and who will focus resources on a cure. What the world presently has is a a near-world-wide news black-out on the fact that GcMAF has proven, in multiple clinical studies, to be a cure for early HIV infections in (primarily) young, healthy, recently-infected individuals.
    What can you do to resolve this problem of ignoring a known cure for many years? Please keep in mind that Yamamoto et al are reporting that cures in some patients have come about in 8 weeks. And please keep in mind that GcMAF is a naturally occurring human glyco-protein which HIV destroys, but if it is given to someone who is HIV+ (and
    young, healthy & recently infected), it activates the immune system enough to clear HIV.
    GcMAF can be extracted from pooled human blood plasma and activated with reagents. There is no patent protection on a natural human glyco-protein. So, there can be little excuse for not trying to follow-up on this discovery. GcMAF quickly cures, it is relatively inexpensive and it has no side effects (according to Dr. Nobuto Yamamoto). These claims can’t be made for ANY anti-HIV treatment that is either FDA approved or in clinical study.
    So, in response to my request for action (expanded clinical studies of a known cure), keep in mind that results would be clearly seen in just a few weeks, and that non-patentable GcMAF can be made cheaply. My point is that a modest study of GcMAF would be relatively inexpensive and quick. The cost of the study would be more than off-set by the money saved by not having to pay for life-long treatment at $30K/year for fifty years.
    The economics of a cure verses life-long treatment beg for a fast and focused investment in a GcMAF clinical study. This would NOT be a treatment study. Therefore, I see no reason for a placebo controlled study, as no one has ever been cured of HIV by a placebo. And that may take some getting use to given the past 30 years of treatment studies that were (occasionally) worse than no treatment at all.
    Please respond and explain what your division is doing to get natural (un-patentable) GcMAF into an early treatment clinical study ASAP. No excuses.
    Regards,
    Tom Hemmingsen

  12. Robert Reinhard says:

    The plan for the network restructuring has great potential to provide infrastructure, workforce and capacity responsive to the way the HIV/AIDS and other epidemics operate in the real world and in LMIC countries. To prepare for this change in international settings, a well trained and supported research force is necessary that can accommodate the program. Therefore it may be somewhat inconsistent with the network restructuring plan that, on Aug. 13th, NiH/Fogarty announced a renewal of its Global Infectious Disease Research Training Program but excluding HIV/AIDS research. [co-infectio research is supported] A more efficient Fogarty training program, could be tied especially or also to the purposes and needs of the restructured trial units. Thank you for the post and your recent public meeting discussion of it. I paste a summary of the recent Fogarty grant below with its link
    http://grants.nih.gov/grants/guide/pa-files/PAR-10-260.html
    Purpose. The Fogarty International Center (FIC) encourages renewal and new applications for the Global Infectious Disease Research Training Program. The application must propose a collaborative research training program that will strengthen the capacity of institutions in low-and middle-income countries (LMIC), defined by the World Bank classification system, to conduct infectious disease (excluding HIV/AIDS) research. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, widespread co-infections of HIV/AIDS patients or infections associated with non-communicable disease conditions of poverty in developing countries (see the FIC Strategic Plan http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm and Global Health Initiative http://www.theglobalhealthinitiative.org/).

  13. Jamie Gentille says:

    I appreciate this open discussion and the opportunity to voice my perspective. I am 31 years old and have been HIV positive since I was 3 years old. I acquired the virus through a tainted blood transfusion during open heart surgery. In my 28 years of living with HIV, I have seen the dramatic progress that researchers have made in the treatment and prevention of HIV. I participated in my first Phase 1 Clinical Drug protocol at NIH when I was 10 years old, at which point there were only a handful of medications approved for HIV-infected children. Since then, I have grown up to be a healthy and happy adult, because of the groundbreaking advances made in pediatric HIV research.
    We are now at a crossroad, faced with several options of continuing our work in HIV/AIDS research. I wholeheartedly urge us to choose a path that continues to delve into the world of pediatric HIV/AIDS research, and that builds on our amazing success. I am a part of a population of people who can offer a tremendous amount of information about the long-term effects of HIV infection and antiretroviral therapies. It would be tragic to walk away from the tremendous potential of this. Where would we be if, 30 years ago, we didn’t pursue these research opportunities? I probably wouldn’t be here. Similarly, children all over the world would not have a fighting chance at a healthy life with HIV.
    In a relatively short amount of time, researchers have gleaned vital information about pediatric HIV and perinatal transmission. This progress will continue, but only if we choose to actively pursue this knowledge and research. As someone who has directly benefitted from this groundbreaking research, and who believes in the incredible potential of continued research, I passionately implore NIAID to remain focused on HIV/AIDS research in the pediatric population.