Abstract

We wish to establish an AIDS Clinical Trials Unit (ACTU) at Cabrini Medical Center under the auspices of the NYU/Bellevue ACTU. This unit will enable us to perform the clinical trials on new drugs for the treatment of HIV infection and its complications. We will take advantage of the very large number of HIV-infected individuals cared for as both inpatients and outpatients at Cabrini Medical Center. We are particularly interested in enrolling into these trials the large number of members of minority ethnic groups that receive their care at our institution. Given the fact that the investigators at Cabrini will not be charged to the grant, both Cabrini and NYU are excited at the opportunity to greatly increase the number of patients accrued in the clinical trials at only and incremental cost to the program. Our participation in the clinical trials will be supervised by members of the NYU ACTU, and NYU will perform our HIV cultures and flow cytometry. We anticipate that the majority of patients will enter Phase II-III trials, or Phase I trials involving ambulatory patients. Phase I trials involving pharmacokinetic measurements or hospitalizations solely for purposes of research will be conducted in the general clinical research unit at NYU.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI027665-09
Application #
3727162
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
9
Fiscal Year
1995
Total Cost
Indirect Cost

  Institution

Name
New York University
Department
Type
DUNS #
004514360
City
New York
State
NY
Country
United States
Zip Code
10012

  Publications

Gupta, Samir K; Yeh, Eunice; Kitch, Douglas W et al. (2017) Bone mineral density reductions after tenofovir disoproxil fumarate initiation and changes in phosphaturia: a secondary analysis of ACTG A5224s. J Antimicrob Chemother 72:2042-2048
Gupta, S K; Kitch, D; Tierney, C et al. (2015) Markers of renal disease and function are associated with systemic inflammation in HIV infection. HIV Med 16:591-8
Longenecker, Chris T; Kitch, Douglas; Sax, Paul E et al. (2015) Reductions in Plasma Cystatin C After Initiation of Antiretroviral Therapy Are Associated With Reductions in Inflammation: ACTG A5224s. J Acquir Immune Defic Syndr 69:168-77
Gupta, Samir K; Kitch, Douglas; Tierney, Camlin et al. (2014) Cystatin C-based renal function changes after antiretroviral initiation: a substudy of a randomized trial. Open Forum Infect Dis 1:ofu003
Erlandson, Kristine Mace; Kitch, Douglas; Tierney, Camlin et al. (2014) Impact of randomized antiretroviral therapy initiation on glucose metabolism. AIDS 28:1451-61
Wyatt, Christina M; Kitch, Douglas; Gupta, Samir K et al. (2014) Changes in proteinuria and albuminuria with initiation of antiretroviral therapy: data from a randomized trial comparing tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine. J Acquir Immune Defic Syndr 67:36-44
Safren, Steven A; Biello, Katie B; Smeaton, Laura et al. (2014) Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. PLoS One 9:e104178
McComsey, Grace A; Kitch, Douglas; Sax, Paul E et al. (2014) Associations of inflammatory markers with AIDS and non-AIDS clinical events after initiation of antiretroviral therapy: AIDS clinical trials group A5224s, a substudy of ACTG A5202. J Acquir Immune Defic Syndr 65:167-74
Erlandson, Kristine M; Kitch, Douglas; Tierney, Camlin et al. (2013) Weight and lean body mass change with antiretroviral initiation and impact on bone mineral density. AIDS 27:2069-79
Gandhi, Rajesh T; Bosch, Ronald J; Aga, Evgenia et al. (2013) Residual plasma viraemia and infectious HIV-1 recovery from resting memory CD4 cells in patients on antiretroviral therapy: results from ACTG A5173. Antivir Ther 18:607-13

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