|Clinical Trials Units Selected for Newly Restructured
HIV/AIDS Research 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
- onducting 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/daids/Networks/daidsnetworkunits.htm).
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,
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
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. News releases, fact sheets and
other NIAID-related materials are available on the NIAID Web site
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 www.nih.gov.