Case Western Reserve University proposes to establish a Clinical Trials Unit (CTU) with clinical research sites (CRSs) at Case/University Hospitals of Cleveland (UHC), MetroHealth Medical Center in Cleveland and the Joint Clinical Research Center (JCRC) in Kampala, Uganda. These three sites have been invited to join the AIDS Clinical Trials Group (ACTG);the Case/UHC CRS as the lead site of a highly productive microbicide development program has also been invited to join the Microbicides Treatment Network (MTN) and though not formally invited, the Case/UHC CRS and the JCRC CRS propose participation with the HIV Vaccine Trials Network (HVTN) in trials of HIV vaccines. The AIDS Clinical Trials Unit (ACTU) at Case has been continuously funded as part of the ACTG since 1987. In this period, the Case ACTU has had a stellar record of clinical trials performance. As a recent example, this ACTU was ranked #2 in total accruals to ACTG trials in the past three years and has always met or exceeded expectations in all aspects of clinical trials performance. The overriding theme of the Case CTU is to bring to the clinical trials research agenda the fruits of basic and translational research that is ongoing at our institutions. Established scientific strengths of the unit have been in the arenas of immunologic monitoring, vaccine and other immune based therapeutic studies, studies of hepatitis C infection and of the metabolic complications of HIV disease. Not surprisingly therefore, Case with its subunits at UHC and MetroHealth Medical Center has been ranked #1 in scientific contributions to the ACTG over the past three years. With a more than 17 year history of scientific collaboration with clinicians and researchers in Uganda that includes the development of a sophisticated and productive laboratory and clinical trials research infrastructure at the JCRC, inclusion of this CRS as a member of the Case CTU is reasonable. As Case investigators are leading the AIDS Malignancy Consortium (AMC) international research effort and also are leading the Oral HIV Research Alliance (OHARA), the Case CTU will help bring together clinical and laboratory researchers from diverse disciplines to address in collaboration the most compelling questions in HIV research and care in the United States and in the developing world. ADMINISTRATIVE COMPONENT:

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 #
5UM1AI069501-07
Application #
8402561
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Adedeji, Bola
Project Start
2007-02-13
Project End
2013-11-30
Budget Start
2012-12-01
Budget End
2013-11-30
Support Year
7
Fiscal Year
2013
Total Cost
$2,944,131
Indirect Cost
$932,078
Name
Case Western Reserve University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Sharaf, Radwa; Lee, Guinevere Q; Sun, Xiaoming et al. (2018) HIV-1 proviral landscapes distinguish posttreatment controllers from noncontrollers. J Clin Invest 128:4074-4085
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
Utay, Netanya S; Kitch, Douglas W; Yeh, Eunice et al. (2018) Telmisartan Therapy Does Not Improve Lymph Node or Adipose Tissue Fibrosis More Than Continued Antiretroviral Therapy Alone. J Infect Dis 217:1770-1781
Hosseinipour, Mina C; Kang, Minhee; Krown, Susan E et al. (2018) As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial. Clin Infect Dis 67:251-260
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
Ippolito, Matthew M; Jacobson, Jeffrey M; Lederman, Michael M et al. (2018) Effect of Antiretroviral Therapy on Plasma Concentrations of Chloroquine and Desethyl-chloroquine. Clin Infect Dis 67:1617-1620
Venuto, Charles S; Lim, Jihoon; Messing, Susan et al. (2018) Inflammation investigated as a source of pharmacokinetic variability of atazanavir in AIDS Clinical Trials Group protocol A5224s. Antivir Ther 23:345-351
Kelesidis, Theodoros; Moser, Carlee B; Johnston, Elizabeth et al. (2018) Brief Report: Changes in Plasma RANKL-Osteoprotegerin in a Prospective, Randomized Clinical Trial of Initial Antiviral Therapy: A5260s. J Acquir Immune Defic Syndr 78:362-366
Rai, Mohammad A; Pannek, Sam; Fichtenbaum, Carl J (2018) Emerging reverse transcriptase inhibitors for HIV-1 infection. Expert Opin Emerg Drugs 23:149-157
Shive, Carey L; Judge, Chelsey J; Clagett, Brian et al. (2018) Pre-vaccine plasma levels of soluble inflammatory indices negatively predict responses to HAV, HBV, and tetanus vaccines in HCV and HIV infection. Vaccine 36:453-460

Showing the most recent 10 out of 175 publications