Clinical Trials Units Selected for Newly Restructured HIV/AIDS Clinical Trials NetworksDate: March 12, 2007
Source: National Institutes of Health (NIH)
Author: National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials Units Selected for Newly Restructured HIV/AIDS Clinical Trials Networks
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), today announced 60 U.S. and international institutions selected as HIV/AIDS Clinical Trials Units (CTUs) in a newly restructured system of six HIV/AIDS clinical research networks. NIAID expects to fund additional CTUs within the next several months, bringing the total to 73.
"These Clinical Trials Units will carry out the next generation of HIV/AIDS vaccine, prevention and treatment research," says NIAID Director Anthony S. Fauci, M.D. "They will work with our clinical research networks in a flexible, collaborative and coordinated way to tackle the critical research questions that can help accelerate progress against the HIV/AIDS pandemic." NIAID supports the world¿s largest HIV/AIDS clinical research effort.
The CTU awards represent the second step of a two-part restructuring process of NIAID¿s HIV/AIDS clinical trials networks. NIAID announced the clinical investigators and institutions responsible for leading the new networks in June 2006 (see http://www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm).
Each CTU is a member of one or more of the six NIAID HIV/AIDS networks: the AIDS Clinical Trials Group, the HIV Prevention Trials Network, the HIV Vaccine Trials Network, the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, the International Network for Strategic Initiatives in Global HIV Trials, and the Microbicide Trials Network.
The HIV/AIDS networks and their CTUs will pursue an integrated research approach to conducting clinical trials designed to address the highest priorities in HIV/AIDS research, including
Developing a safe and effective HIV vaccine
Conducting research for new drug development designed to translate lab findings into clinical applications
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
Each unit will be led by a principal investigator and include an administrative component, community advisory board and one or more clinical research sites¿such as medical schools, academic health centers, hospitals or outpatient clinics¿where studies will be conducted. A list of 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/
The U.S.-based CTUs will be located in the following 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.
The CTUs located outside of the United States are in the following countries: the Dominican Republic, Haiti, Jamaica, Peru, South Africa and Switzerland. Additional CTUs are anticipated in Brazil, China, France, India and Thailand.
The 145 clinical research sites where trials will be performed may be located in different states or countries than the CTUs to which they are affiliated. In addition to the CTU locations noted above, clinical research sites are also anticipated in Michigan, Oklahoma, Rhode Island and Virginia and internationally in Botswana, Malawi, Panama, Tanzania, Uganda, Vietnam, Zambia and Zimbabwe.
The selection process for the CTUs involved a rigorous and extensive scientific peer review of the CTUs¿ proposed clinical programs and capabilities, including access to populations most affected or threatened by the HIV/AIDS epidemic, particularly women, children, adolescents and people of diverse ethnic or racial backgrounds.
Total funding for the clinical trials networks and the CTUs and their affiliated clinical research sites is expected to reach $285 million during the first year of the awards. This also includes funding for previously existing CTUs and clinical research sites to continue their participation in ongoing studies for a period of time to ensure that there are no gaps in current HIV/AIDS research studies.
Planning for the network restructuring began in October 2001 with extensive consultations between NIAID staff and other researchers, clinicians, patient advocates and people living with or at risk for developing HIV/AIDS.
The NIAID HIV/AIDS clinical trials networks are also co-funded and supported by a number of other NIH Institutes and centers that conduct collaborative research studies with the networks.
For additional information about the HIV/AIDS clinical trials units, see http://www3.niaid.nih.gov/news/QA/CTU07QA.htm.
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--ncludes 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