NIH Announces Restructured HIV Clinical Trials Networks

Cross-posted from NIAID Newsroom

Grant Awards Set Stage for Next Seven Years of Science-Driven HIV Clinical Research

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced [on November 30] the clinical investigators and institutions that will lead four NIH HIV clinical trials networks over the next seven years to conduct the innovative, efficient clinical research needed to accelerate progress against the HIV pandemic. NIAID also awarded grants to 35 U.S. and international institutions selected as HIV clinical trials units (CTUs). NIAID and co-funding NIH Institutes intend to provide approximately $375.3 million in the first year to support the networks.

“Achieving a durable end to the HIV pandemic will require continued development of new HIV prevention and treatment strategies, as well as optimal implementation of existing tools,” said NIAID Director Anthony S. Fauci, M.D. “The new network structure will increase the efficiency and effectiveness of NIH’s HIV clinical trial operations to expediently address the critical research questions that will bring us closer to this goal, while always ensuring the safety of clinical trial participants.”

The process of refining the NIH HIV clinical trials networks began in 2017 and involved extensive consultations with researchers, clinicians, advocates, people with or at risk of HIV, and other stakeholders. The new, streamlined network structure will reduce administrative and oversight costs, allowing more funds to be allocated to clinical trials to advance four key areas of research emphasis: HIV prevention; HIV vaccines; HIV/AIDS adult therapeutics; and HIV/AIDS maternal, adolescent and pediatric therapeutics. The networks also have the flexibility to leverage their infrastructure to rapidly respond to emerging infectious diseases, such as coronavirus disease 2019 (COVID-19).

The new structure includes one network that will focus on development of a safe, effective and durable preventive HIV vaccine, and one that will work to advance an array of non-vaccine HIV prevention products and strategies to meet the needs and preferences of diverse populations worldwide. Two therapeutics networks will develop and evaluate potential new treatments and cure strategies for HIV and HIV-related complications and co-infections. One of these networks will focus on adults, while the other will focus on infants, children, adolescents, and pregnant and postpartum women. HIV prevention and vaccine research for the maternal, pediatric and adolescent populations will be led by the HIV prevention and vaccine networks, with assistance from the therapeutics network focused on these populations.

The four networks will direct, coordinate and conduct NIH-funded clinical research worldwide in close collaboration with one another, NIAID, other partner NIH Institutes and Centers, industry and non-governmental research organizations. Each network is led by a leadership and operations center (LOC) and includes a laboratory center (LC) and a statistical and data management center (SDMC). The principal investigators, institutions and grant numbers for these awards are as follows:

HIV Vaccine Trials Network (HVTN)
LOC: Lawrence Corey, Dan H. Barouch, Glenda E. Gray, Georgia D. Tomaras; Fred Hutchinson Cancer Research Center, Seattle; 2 UM1 AI068614-15
LC: Margaret J. McElrath; Fred Hutchinson Cancer Research Center, Seattle; 2 UM1 AI068618-15
SDMC: Peter B. Gilbert, Yunda Huang, Holly Janes; Fred Hutchinson Cancer Research Center, Seattle; 2 UM1 AI068635-15

HIV Prevention Trials Network (HPTN)
LOC: Myron S. Cohen, Wafaa M. El-Sadr; Family Health International, Durham, North Carolina; 2 UM1 AI068619-15
LC: Susan H. Eshleman; Johns Hopkins University, Baltimore; 2 UM1 AI068613-15
SDMC: Deborah J. Donnell; Fred Hutchinson Cancer Research Center, Seattle; 2 UM1 AI068617-15

AIDS Clinical Trials Group (ACTG)
LOC: Judith S. Currier, Joseph J. Eron; University of California Los Angeles; 2 UM1 AI068636-15
LC: Grace M. Aldrovandi; University of California Los Angeles; 2 UM1 AI106701-08
SDMC: Michael D. Hughes, Marlene Cooper; Harvard School of Public Health, Boston; 2 UM1 AI068634-15

International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT)
LOC: Sharon A. Nachman; Johns Hopkins University, Baltimore; 2 UM1 AI068632-15
LC: Grace M. Aldrovandi; University of California Los Angeles; 2 UM1 AI106716-09
SDMC: David E. Shapiro, Marlene Cooper; Harvard School of Public Health, Boston; 2 UM1 AI068616-15

The 35 CTUs will provide scientific and administrative expertise, as well as the infrastructure to conduct clinical trials within the networks. A complete list of CTUs, including principal investigators and their affiliations, is available online. Each CTU supports up to eight clinical research sites. Collectively, the CTUs support 101 clinical research sites in 18 countries across North America, South America, Africa and Asia. This includes 45 sites in the United States. View a map showing the clinical research site locations.

The other NIH Institutes that will collaborate with one or more of the HIV clinical trials networks include the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); the National Institute of Dental and Craniofacial Research (NIDCR); the National Institute on Drug Abuse (NIDA); the National Institute of Mental Health (NIMH); and the National Institute of Neurological Disorders and Stroke (NINDS).

To learn more about these new awards and the process to refine NIH’s HIV clinical trials networks, see NIAID’s Refining the HIV Clinical Trials Enterprise website.