The Seattle-Lausanne Clinical Trials Unit (CTU) has a common vision to live in a world without new HIV infections and free of AIDS-related morbidity and death. To this end, we are committed to accelerate progress over the next seven years to: 1) develop a globally effective HIV vaccine, a combination broad neutralizing antibody immunoprophylaxis regimen that can prevent HIV, and an improved vaccine regimen to prevent Mycobacterium tuberculosis infection; and 2) discover novel and improved therapies that can effectively treat all persons living with HIV, prevent HIV disease and its co-morbidities, and lead to sustained viral remission without the need for ongoing treatment. In this renewal application for NIAID funding in 2020-2027, our CTU proposes continued support of the scientific priorities of the HIV Vaccine Trials Network (HVTN) and the HIV Adult Therapeutic Network (ACTG), through our three existing and highly integrated Clinical Research Sites (CRSs): the Seattle Vaccine Trials Unit (HVTN site), the Lausanne Vaccine and Immunotherapy Center (HVTN site) and the University of Washington AIDS Clinical Trials Unit (ACTG site). Our CTU is operating in a productive and intense period of clinical research on behalf of the networks, and we anticipate a seamless transition from our current portfolio to the proposed new studies initiated in the next cycle. Our CTU leaders and co-investigators are valuable members of the networks? leadership and scientific committees; they chair and participate in high profile first-in-human studies and bring innovative designs to gain insights into the mechanisms by which candidate vaccines and novel therapeutics achieve their desired responses. Furthermore, our CRSs will continue to enroll and follow target populations in clinical trials and contribute outstanding data to advance promising immune-based, antiviral, and other therapeutic strategies. To achieve our vision and address the networks? priorities, in Aim 1 we will harness the collective, diverse expertise of three internationally recognized thought leaders in the HIV field to provide scientific leadership and innovation to the HVTN and ACTG. In parallel, our CTU will advance the research careers, leadership skills and opportunities for early-stage physician scientists to foster the next generation of network investigators.
In Aim 2, our governance and administrative structure will provide a transparent process for decision-making and effective oversight of communication, resource allocation, pharmacy, clinical and regulatory operations, and quality management to enable a highly integrated, productive CTU. In partnership with the HVTN and ACTG, in Aim 3 our three CRSs will conduct phase 1-4 clinical trials with the CTU support necessary to ensure the highest quality standards.
In Aim 4, we will continue to involve our community partners to ensure their input and support, and to optimize enrollment and engagement of relevant populations in our clinical research activities. Importantly, we have the necessary resource commitments from our three institutions as needed to carry out this agenda and will leverage specialized expertise in our rich environment to foster diversity and innovation.

Public Health Relevance

The Seattle-Lausanne CTU has an overall goal to make rapid progress in the development of globally effective HIV and TB vaccines. In addition, we will seek improved therapies to successfully treat all persons living with HIV to prevent HIV disease and associated diseases, and in the long-term hope to achieve sustained viral remission without the need for treatment.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Pouliot, Eileen M
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Fred Hutchinson Cancer Research Center
United States
Zip Code
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

Showing the most recent 10 out of 59 publications