This application will continue the contributions of an existing AIDS Clinical Trails Unit at Washington University School of Medicine in St. Louis for the next seven years. We propose a Clinical Trial Unit with an administrative structure led by Dr. David Clifford facilitating active contribution to the AIDS Clinical Trials Group (ACTG) network (100%) proposed in an application responding to RFA AI-05-001 headed by Dr. Constance Benson. We will conduct clinical research by recruiting, screening, and enrolling research participants in trials responding to clinical research plans in the following areas: (1) Translational Research/Drug Development, (-25) (2) Optimization of Clinical Management, Including Co-Morbidities,(~55%) (2)Prevention of Mother-to-Child Transmission(~10%) (4) Vaccine Research and Development. (~5%) and (5) Prevention of Infection (5%). This application describes a single Clinical Research Site (CRS) at Washington University School of Medicine that will carry out all portions of this research agenda. The CRS application includes plans for recruiting, screening, and enrolling 20 subjects in typical protocols in the above research areas, as well as ongoing work supporting continuing trials organized by the ACTG system with in excess of100 participating subjects at the present time. The St. Louis CTU will also contribute to scientific leadership assisting development of translational research with particular emphasis on the co-morbidities including neurologic conditions, hepatitis, cardiovascular and metabolic complications. Additional scientific leadership and expertise will continue to be developed in areas of new HIV therapies and pediatric and adolescent manifestations of HIV disease. Ongoing support for a vital Community Advisory Board will be continued under this application, assuring the constructive engagement for advise and counsel from affected populations, as well as providing outreach and educational support to affected populations. Funding this application will provide for ongoing contributions of the Washington University AIDS research community in translation of critical scientific concepts to optimal implementation to the benefit of all persons with HIV infection. We anticipate improvements in therapy that will improve the health in our own community, country, and in the much larger international community affected by HIV/AIDS. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI069495-04
Application #
7743830
Study Section
Special Emphasis Panel (ZAI1-DDS-A (M1))
Program Officer
Pouliot, Eileen M
Project Start
2007-02-01
Project End
2013-11-30
Budget Start
2009-12-01
Budget End
2010-11-30
Support Year
4
Fiscal Year
2010
Total Cost
$1,635,616
Indirect Cost
Name
Washington University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
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
Obermeit, Lisa C; Beltran, Jessica; Casaletto, Kaitlin B et al. (2017) Evaluating the accuracy of self-report for the diagnosis of HIV-associated neurocognitive disorder (HAND): defining ""symptomatic"" versus ""asymptomatic"" HAND. J Neurovirol 23:67-78
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
Mehta, Sanjay R; Pérez-Santiago, Josué; Hulgan, Todd et al. (2017) Cerebrospinal fluid cell-free mitochondrial DNA is associated with HIV replication, iron transport, and mild HIV-associated neurocognitive impairment. J Neuroinflammation 14:72
Fazeli, Pariya L; Moore, David J; Franklin, Donald R et al. (2016) Lower CSF A? is Associated with HAND in HIV-Infected Adults with a Family History of Dementia. Curr HIV Res 14:324-30

Showing the most recent 10 out of 125 publications