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.

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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
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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
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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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