The Boston/Jackson/Providence HIV Clinical Trials Unit (BJP HIV CTU) will conduct clinical trials to address research priorities of three NIAID HIV/AIDS Clinical Trials Networks (CTNs): HIV therapeutics; integrated strategies for HIV prevention; and HIV vaccines. The BJP HIV CTU brings together a collaborative group of highly experienced investigators with decades of experience in HIV-related treatment, prevention and vaccine research. The BJP HIV CTU comprises five existing Clinical Research Sites (CRSs): therapeutics CRSs at Brigham and Women?s Hospital (BWH) and Massachusetts General Hospital in Boston, MA and The Miriam Hospital in Providence, RI; a vaccine CRS at BWH; and a combined prevention and vaccine CRS at Fenway Health (also in Boston). Two new CRSs are proposed?a prevention CRS at University of Mississippi Medical Center in Jackson, MS and a vaccine CRS at Beth Israel Deaconess Medical Center (BIDMC) in Boston. The BJP HIV CTU and its component CRSs will function as an integrated, collaborative consortium to coordinate and implement clinical trials designed by the Leadership Groups of the NIAID-funded HIV/AIDS CTNs. The five existing CRSs have been extremely effective in conducting studies and contributing substantially to the scientific agendas of their respective CTNs. Expansion of our existing CTU to include two new CRSs devoted to HIV prevention and vaccine research, respectively, substantially enhances our capacity to conduct clinical trials critical to developing more effective means of HIV prevention and testing candidate vaccines. The proposed UMMC Prevention CRS is located in Jackson, MS a city in the southeastern United States with a predominantly African American population that ranked 4th highest in HIV infection and 5th highest in the rate of AIDS diagnoses among US metropolitan areas. The proposed Vaccine CRS within the Center for Virology and Vaccine Research at BIDMC will engage investigators who have made major and sustained scientific contributions to the HIV vaccine field over the past 15 years. The BJP HIV CTU will be led by three highly experienced PIs, Drs. Daniel Kuritzkes, Kenneth Mayer and Lindsey Baden, and will include highly accomplished CRS leaders and collaborating investigators. The CTU will function as an integrated, highly collaborative consortium that will have centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Centralized resources include a Clinical Research Laboratory, a Research Pharmacy Coordinator, Data and Quality Management Plans and a Community Engagement Core. The CTU has diverse and accessible populations for study, representing communities most affected by HIV. Each CRS has well- grounded connections in the communities in which they are based. The BJP HIV CTU is well-poised to carry out efficient high-quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure will facilitate the conduct of studies that cross traditional CTN boundaries and will enable rapid responses to new scientific priorities as they emerge.
Despite enormous progress, significant challenges remain in preventing, treating and curing HIV infection. The Boston/Jackson/Providence HIV Clinical Trials Unit will carry out innovative clinical trials that address major questions in HIV clinical research. The results of these studies will lead to major improvements in ways to prevent and treat HIV and related diseases.
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