March 12, 2007

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1.		What are the NIAID HIV/AIDS clinical trials units?
		The National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS clinical trials units (CTUs) are the national and international research institutions that conduct clinical HIV/AIDS research to develop safe and effective drugs, prevention strategies and HIV vaccines. Each unit consists of a lead principal investigator, an administrative component and one or more affiliated clinical research sites, such as hospitals and clinics, where qualified medical professionals conduct clinical trial research in accordance with federal and local requirements.
2.		How do the CTUs fit in with the NIAID HIV/AIDS clinical trials networks that were awarded in June 2006?
		Each CTU is a member of one or more of the six NIAID HIV/AIDS networks, which include the AIDS Clinical Trials Group (ACTG), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) and the Microbicide Trials Network (MTN). The CTUs will collaborate with the network’s leadership and local communities to conduct clinical trials addressing the highest priorities in HIV/AIDS research, including Developing a safe and effective HIV vaccine Conducting translational research for new drug development Optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions Developing microbicides to prevent HIV acquisition and transmission Creating strategies to prevent mother-to-child HIV transmission Developing new methods of HIV prevention
3.		Which institutions did NIAID select to serve as CTUs in its HIV/AIDS program?
		NIAID expects to fund up to 73 U.S. and international institutions as its CTUs. In the United States, the CTUs will be located in the following 18 states and territories: Alabama, California, Colorado, Florida, Georgia, Illinois, Maryland, Massachusetts, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Washington and Puerto Rico. Additional CTUs are expected in Louisiana and Washington, D.C. Outside the United States, the CTUs will be located in the following six countries: the Dominican Republic, Haiti, Jamaica, Peru, South Africa and Switzerland. Additionally, NIAID expects to also fund CTUs in Brazil, China, France, India and Thailand. A complete list of the CTUs that have received awards to date along with the principal investigators who will lead the CTUs and their affiliated clinical research sites can be accessed at http://www3.niaid.nih.gov/about/organization/daids/ Networks/daidsnetworkunits.htm
4.		How many clinical research sites will be funded in connection with the HIV/AIDS CTUs?
		In addition to the 73 CTUs, funding will also support up to 145 clinical research sites. The clinical research sites will carry out the actual research and can be affiliated with more than one CTU and more than one network.
5.		What is the amount of the NIAID CTU awards?
		Total funding for the six clinical trials networks, the CTUs and their affiliated clinical research sites is expected to reach $285 million during the first year of the awards. The length of each award varies but may be up to seven years.
6.		What process did NIAID use to solicit applicants for the HIV/AIDS networks and the CTUs?
		NIAID issued two separate but linked Requests for Applications (RFAs) for the HIV/AIDS networks and CTUs: one to solicit network leadership applications and the other to solicit the CTU applications. The RFA for the CTUs, which was issued in February 2005 and closed in July 2005, was open to any domestic or foreign, public or private organization, including universities, colleges, hospitals, laboratories, divisions of state and local governments and eligible agencies of the federal government. The RFA for the network leadership was issued in November 2004 and closed in May 2005.  NIAID announced its selection of the HIV/AIDS network leadership on June 29, 2006. http://www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm.
7.		How were the applications for the CTUs reviewed?
		The 121 applications submitted in response to the Units for HIV/AIDS Clinical Trial Networks RFA underwent extensive scientific peer review of proposed clinical programs and capabilities. A secondary level of peer review was provided by the National Advisory Allergy and Infectious Diseases Council. Peer reviewers evaluated each application for scientific significance, approach, innovation, quality of the potential investigators and RFA-specific review criteria. The applications were also examined for plans for protecting human research volunteers and for including women, minorities and children in research studies.
8.		How did NIAID decide which CTUs and clinical research sites to fund?
		The final selection of CTUs and clinical research sites was based primarily on the results of the scientific peer review process, as well as other factors, including NIAID’s scientific priorities, population, geographic distribution, budget and past performance.
9.		Why are some CTUs being phased out?
		The RFA for the Units for HIV/AIDS Clinical Trials Networks represented a new competition for funding; neither previous funding nor past performance guaranteed new funding under this application process. The CTU applications, including those from previously funded units, underwent an extensive scientific peer review in late February 2006. All of the applications received a careful and thorough review based on the objective criteria noted in the RFA. The final selection of CTUs and their associated clinical research sites was based primarily on the results of the scientific peer review, although other factors, including NIAID’s highest scientific priorities, population, geographic distribution, budget and the previous performance of the CTU also were taken into consideration. Not all previously funded units were found through the peer review process to be as qualified as other applicants or capable of adequately meeting the criteria noted above.
10.		What will happen to HIV/AIDS clinical studies that are already under way at previously funded units and sites?
		NIAID will ensure that there are no gaps in funding for current HIV/AIDS research studies by extending, as necessary, funding for previously existing CTUs and clinical research sites to allow for the continuation of ongoing research for a period of time or to begin the phase-out process. Sixty-two sites will receive funding to phase-out their current research studies.
11.		How was the balance between U.S. and international clinical research units and sites determined?
		Historically, there have been substantially more U.S.-based clinical trials units and sites in the networks, but as HIV/AIDS has become a global disease, it is important to shift that balance. While there is still a greater number of CTUs in the United States, the number of international units is larger than in the past. NIAID’s plan for restructuring the HIV/AIDS networks was formulated after several years of consultation with researchers, clinicians, community members, nurses, patient advocates and people living with and at risk of developing HIV/AIDS. The plan was then reviewed by NIAID’s AIDS Research Advisory Committee. The advice and guidance that resulted from those consultations was that, given the ever-changing face of the HIV/AIDS epidemic and evolving scientific challenges, the network structure for conducting clinical research in this area needs to evolve to better address global research needs. For example, HIV prevention research requires study participants from regions with a high rate of HIV incidence and prevalence. Greater numbers of women and adolescents as well as people of diverse ethnic and racial backgrounds are also needed. For HIV vaccine research in particular, it is extremely important to include people in regions where different clades, or subtypes, of HIV are dominant. This expanded geographic approach will help ensure that HIV/AIDS research is conducted in the most effective and expeditious way possible so that study results have broad applicability.
12.		How does the restructuring relate, if at all, to the priorities of the Global HIV/AIDS Vaccine Enterprise?
		The scientific strategic plan of the Global HIV/AIDS Vaccine Enterprise calls for building clinical site capacity that positions sites to “contribute to other research of public health importance to the community and the country, including, for example, other areas of HIV research (e.g., microbicides and treatment) and/or other diseases.” NIAID’s restructuring encouraged applications from clinical trials units that have the capability to conduct clinical research in multiple scientific areas. Thus, NIAID’s support for clinical trials units and their associated clinical trials sites is consistent with and supports the priorities of the Global HIV/AIDS Vaccine Enterprise.
13.		Are other NIH Institutes and centers working with NIAID on this HIV/AIDS research?
		Yes. An important goal of restructuring NIAID’s HIV/AIDS clinical trials networks is to increase the coordination of HIV therapeutic and prevention research and to foster collaboration among the different networks. The networks are co-funded and supported by a number of other NIH Institutes and centers that conduct collaborative research studies with the HIV/AIDS networks.

Media inquires can be directed to the NIAID News and Public Information Branch at 301-402-1663, niaidnews@niaid.nih.gov.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov

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