HIV/AIDS Clinical Trials Networks

NIH Names Leadership, Research Units for Restructured HIV/AIDS Clinical Trials Networks

Principal investigators and clinical trials units (CTUs) have been chosen to lead and conduct the research of five HIV/AIDS clinical trials networks through 2021. The effort is directed and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Total funding for the networks’ leadership and the CTUs is expected to reach $225 million in 2014, the first year of operation.

“With much recent progress, this is a very exciting time in HIV/AIDS research. The next seven years will be a critical period as we pursue the now-achievable goal of an AIDS-free generation, one in which new infections and deaths from AIDS are very rare,” said NIAID Director Anthony S. Fauci, M.D. “These new awards position us to build upon the success of our current HIV/AIDS clinical research infrastructure by creating a broader, more flexible, and more collaborative approach to domestic and global HIV/AIDS research priorities.”  

Planning for restructuring of the HIV/AIDS clinical trials networks began in 2010 and involved extensive consultations with researchers, clinicians, nurses, patient advocates and other activists, and people living with HIV or at risk for infection. The new awards are intended to expand the scope of the network’s current activities to include the treatment and prevention of other infectious diseases, notably tuberculosis and hepatitis, which are the most significant co-infections for people who are infected with HIV or at risk for infection.

The new structure is designed to increase collaboration across the networks, create transparent mechanisms for network leaders to solicit and support ideas from the research community, and develop a means for external researchers to tap into the networks’ clinical trial infrastructure and capacity.

Leadership Groups

Each leadership group will be led by one or more principal investigators and include a core operations group, a central laboratory and a statistical and data management center. The following principal investigators and institutions will lead the five HIV/AIDS networks:

·         AIDS Clinical Trials Group (ACTG): Daniel R. Kuritzkes, M.D.; Brigham and Women’s Hospital, Boston

·         HIV Prevention Trials Network (HPTN): Wafaa El-Sadr, M.D., M.P.H., and Myron Cohen, M.D.; Family Health International, Durham, N.C.

·         HIV Vaccine Trials Network (HVTN): Lawrence Corey, M.D., Glenda Gray, M.B.B.Ch., and Scott Hammer, M.D.; The Fred Hutchinson Cancer Research Center, Seattle

·         International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network: Jay Brooks Jackson, M.D.; Johns Hopkins University School of Medicine, Baltimore

·         Microbicide Trials Network (MTN): Sharon L. Hillier, Ph.D., and Ian Michael McGowan, M.D., Ph.D.; Magee-Womens Research Institute and Foundation, Pittsburgh

The leadership groups will have overall responsibility for developing, implementing and adapting clinical research agendas to address NIAID’s HIV/AIDS scientific priorities, including

·         Therapeutics for HIV/AIDS and HIV-associated infections in adults (including HIV cure, as well as co-occurring noninfectious and infectious diseases, including hepatitis and tuberculosis).

·         HIV/AIDS and HIV-associated infections in children and mothers

·         Integrated strategies to prevent HIV infection

·         Vaccines to prevent HIV infection

·         Microbicides to prevent HIV infection

They are expected to direct, coordinate and conduct NIAID-funded HIV/AIDS clinical research worldwide in close collaboration with one another, NIAID, other partner NIH institutes, and industry, foundations, and non-governmental research organizations.

Clinical Trials Units

In addition to the leadership groups, NIAID also named the 37 CTUs responsible for implementing the scientific agendas of the networks. Each CTU includes an administrative component with performance and resource management responsibilities and clinical research sites—the hospitals, outpatient clinics, health maintenance organizations, community health centers, private physician practices and clinics where clinical trials are conducted. Each CTU will affiliate with at least two of the five HIV/AIDS networks and have the option to work with other NIAID clinical networks, including NIAID’s newly developed Antibacterial Resistance Clinical Research Network.

A principal investigator will lead each of the CTUs. For a complete list of those principal investigators and their affiliations, see the related table for details.

The U.S.-based CTUs will be located in Alabama, California, the District of Columbia, Florida, Georgia, Illinois, Maryland, Massachusetts, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Washington state and Puerto Rico. The CTUs located outside of the United States are in Botswana, Brazil, China, Haiti, India, Kenya, Malawi, Mozambique, Peru, South Africa, Tanzania, Thailand, Switzerland, Uganda, Zambia, and Zimbabwe.

For a complete list of the 108 clinical research sites, see the related table for details.

Through the coordination of the NIH Office of AIDS Research, the other NIH institutes that will collaborate with one or more of the HIV/AIDS clinical trials networks and NIAID include the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, the National Institute on Drug Abuse, the National Institute of Dental and Craniofacial Research, the National Institute of Neurological Disorders and Stroke and the National Cancer Institute.

For more details about the network leadership groups, the CTUs and clinical research sites, see the Restructuring the NIAID Clinical Trials Networks website.