The Seattle-Lausanne-Kampala Clinical Trials Unit (SLK CTU) shares a common goal over the next seven years to work toward a world free of AIDS. The proposed CTU, administered through Fred Hutchinson Cancer Research Center (FHCRC), will consolidate three current high-performing CTUs and add one new experienced, high-capacity CRS in sub-Saharan Africa. The SLK CTU will harness the collective diverse expertise of six international HIV-1 leaders who have made significant contributions to improve HIV-1 vaccine development, prevention and care over the past 2-3 decades. The four integrated Clinical Research Sites (CRSs) will address four NIAID HIV network leadership agendas: Seattle VMP (vaccine, microbicide, and prevention), UW ACTU in Seattle (adult therapeutic), Lausanne VIC (Centre Hospitaller Universitaire Vaudois) (vaccine), and Kasangati-lnfectious Diseases Institute (IDI) in Kampala (prevention and adult therapeutic). To accomplish the CTU's common goal and the networks' agendas, clinical research studies and activities will be directed toward the following four specific aims:
Specific Aim 1 : Contribute leadership and expertise to address current and new scientific priorities related to HIV-1 vaccination, prevention, microbicides and therapeutics.
Specific Aim 2 : Provide centralized administrative oversight through consolidation of the current infrastructure and operations of our existing CTUs and clinical trials programs, to integrate and expand the CRS activities within the four networks.
Specific Aim 3 : Conduct phase 1-3 clinical trials under the direction of the four NIAID- sponsored HIV networks and provide the trial support necessary to ensure the highest quality standards of clinical research.
Specific Aim 4 : Continue and extend partnerships with the CRS communities and stakeholders to enlist their support and guarantee successful enrollment and participation of relevant study populations that are impacted by the HIV epidemic. Our CTU recognizes the challenges moving forward. Inherent characteristics of our structure, expertise, and ability to leverage related activities in our rich environment offer innovation to te clinical trials networks.

Public Health Relevance

The progression of the HIV epidemic, as well as its international, political and economic toll, make a compelling case for effective vaccine, prevention, microbicide and treatment strategies. In order to reduce the spread of this global pandemic, we propose an innovative clinical trials unit with demonstrated productivity to effectively test candidate regimens to address these fields of study.

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 #
5UM1AI069481-09
Application #
8784168
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Greenfield, Teri L
Project Start
2007-02-01
Project End
2020-11-30
Budget Start
2014-12-01
Budget End
2015-11-30
Support Year
9
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Torres, Thiago S; Harrison, Linda J; La Rosa, Alberto M et al. (2018) Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings. AIDS Care 30:954-962
Fong, Youyi; Shen, Xiaoying; Ashley, Vicki C et al. (2018) Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial. J Infect Dis 217:1280-1288
Stockdale, Alexander J; Saunders, Matthew J; Boyd, Mark A et al. (2018) Effectiveness of Protease Inhibitor/Nucleos(t)ide Reverse Transcriptase Inhibitor-Based Second-line Antiretroviral Therapy for the Treatment of Human Immunodeficiency Virus Type 1 Infection in Sub-Saharan Africa: A Systematic Review and Meta-analysis. Clin Infect Dis 66:1846-1857
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
Riddler, Sharon A; Zheng, Lu; Durand, Christine M et al. (2018) Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART. Open Forum Infect Dis 5:ofy242
Torres, Thiago S; Harrison, Linda J; La Rosa, Alberto M et al. (2018) Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women. AIDS 32:583-593
Nixon, Daniel E; Bosch, Ronald J; Chan, Ellen S et al. (2017) Effects of atorvastatin on biomarkers of immune activation, inflammation, and lipids in virologically suppressed, human immunodeficiency virus-1-infected individuals with low-density lipoprotein cholesterol <130 mg/dL (AIDS Clinical Trials Group Study A52 J Clin Lipidol 11:61-69
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
Gulick, Roy M; Wilkin, Timothy J; Chen, Ying Q et al. (2017) Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial. Ann Intern Med 167:384-393
Gandhi, Rajesh T; McMahon, Deborah K; Bosch, Ronald J et al. (2017) Levels of HIV-1 persistence on antiretroviral therapy are not associated with markers of inflammation or activation. PLoS Pathog 13:e1006285

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