The NYU/Bellevue CTU's proposal is to support three Clinical Research Sites, two domestic sites affiliating with the ACTG and HVTN and one international site in Mombasa, Kenya. The three individual sites currently work in close collaboration largely through the efforts of our NIAID sponsored Center for AIDS Research (CFAR),directed by Dr. Fred Valentine. It should be noted that our CFAR was just refunded in 2005 for an additional 5 year period. Specimen management and laboratory measurements are cjrrently provided by the same CFAR laboratories for both the ACTU and Vaccine studies. All three sites have demonstrated their ability to recruit, accrue and retain subjects in studies addressing the high priority scientific research detailed in the RFA. All three sites meet the CRS- required capabilities to: recruit, screen, and enroll participants;perform protocol required assessments;manage study products;dispense investigational agents;monitor for, assess arid report adverse events;collect, process, store and ship specimens;collect, manage and submit clinical research data, that meets all data reporting requirements of the Network(s) and DAIDS conduct internal quality assurance create, maintain and store research records including participant files, source documents, regulatory files, subject identification information, clinical reports, and case report forms. As PI of the CTU, Dr. Aberg accepts the primary responsibilities outlined in the application and additionally as she is Director of HIV for Bellevue Hospital Center, she assures that any subjects who become HIV positive while participating in an HIV vaccine trial will be appropriately and immediately offered primary care either at Bellevue or a clinic of that subject's preference as well as information on available clinical trials evaluating primary infection. The ACTG and HVTN have contributed immensely to the clinical care of persons living with HIV as reflected by the numerous references to ACTG studies in all the national guidelines. Our unit has given significant scientific contributions to the concept and design of many studies and will continue to do so. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069532-04
Application #
7743393
Study Section
Special Emphasis Panel (ZAI1-SR-A (M2))
Program Officer
Welsch, Sue A
Project Start
2007-01-15
Project End
2013-11-30
Budget Start
2009-12-01
Budget End
2010-11-30
Support Year
4
Fiscal Year
2010
Total Cost
$1,625,568
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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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
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
Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
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
Verma, Anurag; Bradford, Yuki; Verma, Shefali S et al. (2017) Multiphenotype association study of patients randomized to initiate antiretroviral regimens in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 27:101-111
Bednasz, Cindy J; Venuto, Charles S; Ma, Qing et al. (2017) Efavirenz Therapeutic Range in HIV-1 Treatment-Naive Participants. Ther Drug Monit 39:596-603
Riddler, Sharon A; Aga, Evgenia; Bosch, Ronald J et al. (2016) Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1-Infected Adults Receiving Long-term Antiretroviral Therapy. J Infect Dis 213:556-60
Danoff, Ann; Kendall, Michelle A; Currier, Judith S et al. (2016) Soluble Levels of Receptor for Advanced Glycation Endproducts (RAGE) and Progression of Atherosclerosis in Individuals Infected with Human Immunodeficiency Virus: ACTG NWCS 332. Inflammation 39:1354-62

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