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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI069412-15
Application #
10057052
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Germuga, Donna E
Project Start
2007-01-15
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Brigham and Women's Hospital
Department
Type
DUNS #
030811269
City
Boston
State
MA
Country
United States
Zip Code
02115
Kalayjian, Robert C; Albert, Jeffrey M; Cremers, Serge et al. (2018) Women have enhanced bone loss associated with phosphaturia and CD4+ cell restoration during initial antiretroviral therapy. AIDS 32:2517-2524
Gandhi, Monica; Gandhi, Rajesh T; Stefanescu, Andrei et al. (2018) Cumulative Antiretroviral Exposure Measured in Hair Is Not Associated With Measures of HIV Persistence or Inflammation Among Individuals on Suppressive ART. J Infect Dis 218:234-238
Giguere, Rebecca; Rael, Christine Tagliaferri; Sheinfil, Alan et al. (2018) Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav 22:388-401
Martin, Maureen P; Naranbhai, Vivek; Shea, Patrick R et al. (2018) Killer cell immunoglobulin-like receptor 3DL1 variation modifies HLA-B*57 protection against HIV-1. J Clin Invest 128:1903-1912
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187
Torres, Thiago S; Harrison, Linda J; La Rosa, Alberto M et al. (2018) Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings. AIDS Care 30:954-962
Taiwo, Babafemi O; Zheng, Lu; Stefanescu, Andrei et al. (2018) ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL. Clin Infect Dis 66:1689-1697
MacBrayne, Christine E; Marks, Kristen M; Fierer, Daniel S et al. (2018) Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother 73:2112-2119
Strongin, Zachary; Sharaf, Radwa; VanBelzen, D Jake et al. (2018) Effect of Short-Term Antiretroviral Therapy Interruption on Levels of Integrated HIV DNA. J Virol 92:
Baden, Lindsey R; Walsh, Stephen R; Seaman, Michael S et al. (2018) First-in-Human Randomized, Controlled Trial of Mosaic HIV-1 Immunogens Delivered via a Modified Vaccinia Ankara Vector. J Infect Dis 218:633-644

Showing the most recent 10 out of 117 publications