The UCSD Collaborative Clinical Trials Unit (CTU) will bring together seven dynamic U.S. and International Clinical Research Sites (CRSs) to facilitate innovative scientific synergies and leverage research collaborations among investigators across our CTU and to contribute our scientific expertise and our diverse participant populations to further the research priorities of the NIAID HIV/AIDS Adult Therapeutics Clinical Trials Network and the HIV Prevention Clinical Trials Network. Our seven CRSs include: 1) the UCSD Antiviral Research Center (AVRC) CRS; 2) the University of Southern California (USC) CRS; 3) the University of Colorado Hospital (UCH) CRS; 4) the Houston AIDS Research Team (HART) CRS; 5) the University of Miami CRS; 6) the Chennai Antiviral Research and Treatment (CART) CRS, and; 7) the Durban International (DI) CRS. Each will bring considerable strength to achieve the future research goals of two of the four NIAID networks. Our Collaborative CTU brings together a wealth of expertise, experience, and the high quality performance required to conduct complex clinical trials in the following areas: HIV cure and functional cure; viral persistence and latent reservoirs; broadly neutralizing antibody approaches to treatment and prevention of HIV; pathogenesis and treatment of HIV-related inflammation, coinfections and comorbidities; new antiretroviral drugs and novel formulations for HIV treatment and prevention; treatment and prevention of tuberculosis (TB) in persons with mono- and HIV-coinfection; and biomedical, socio-behavioral, and multipurpose technology strategies to prevent HIV transmission (including pre-exposure prophylaxis [PrEP], HIV preventive vaccines, and molecular epidemiology to target ?hot spots?) in populations at high risk for HIV transmission. Our CTU provides access to and long-standing experience with community engagement in underrepresented Hispanic/Latinx, Black/African American, African, and South Asian populations at risk for or affected by HIV and its complications. Our U.S. CRSs span several of the highest burden regions for chronic and new HIV infections in the southeast (Miami), south (Houston), southwest (Denver) and border regions (Los Angeles, San Diego) identified in the U.S. ?Plan to End the HIV Epidemic? campaign. Our international CRSs include two of the highest burden regions globally for both HIV and TB, particularly drug-resistant TB (Southern India and South Africa). We will address the following specific aims.
Specific Aim 1 : To provide outstanding, innovative scientific contributions and leadership to the HIV/AIDS Adult Therapeutics Clinical Trials Network and the HIV Prevention Clinical Trials Network.
Specific Aim 2 : To provide effective and efficient administrative and financial resource management.
Specific Aim 3 : To engage and partner with diverse communities affected by HIV to shape network scientific agendas and to recruit, enroll and retain a broad diversity of research trial participants in network studies.

Public Health Relevance

The UCSD Collaborative Clinical Trials Unit (CTU) brings together seven dynamic Clinical Research Sites in the U.S., sub-Saharan Africa, and India, with a proven track record of significant research into the pathogenesis, treatment and prevention of HIV and its related complications and coinfections. Our proposed CTU has the expertise, experience, infrastructure, and access to geographically, racially and ethnically diverse participant populations living with or at risk for HIV to make valuable contributions to the research priorities of the NIAID clinical trials networks.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1)
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Roby, Gregg A,
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University of California, San Diego
Internal Medicine/Medicine
Schools of Medicine
La Jolla
United States
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Cespedes, Michelle S; Kang, Minhee; Kojic, Erna Milunka et al. (2018) Anogenital human papillomavirus virus DNA and sustained response to the quadrivalent HPV vaccine in women living with HIV-1. Papillomavirus Res 6:15-21
Swindells, S; Gupta, A; Kim, S et al. (2018) Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003). Int J Tuberc Lung Dis 22:1016-1022
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
Stein, James H; Yeh, Eunice; Weber, Joanne M et al. (2018) Brachial Artery Echogenicity and Grayscale Texture Changes in HIV-Infected Individuals Receiving Low-Dose Methotrexate. Arterioscler Thromb Vasc Biol 38:2870-2878
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
Robertson, K; Oladeji, B; Jiang, H et al. (2018) HIV-1 and TB Co-infection in Multinational Resource Limited Settings: Increased neurological dysfunction. Clin Infect Dis :
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
Taiwo, Babafemi O; Zheng, Lu; Stefanescu, Andrei et al. (2018) ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL. Clin Infect Dis 66:1689-1697
Dillon, Stephanie M; Guo, Kejun; Austin, Gregory L et al. (2018) A compartmentalized type I interferon response in the gut during chronic HIV-1 infection is associated with immunopathogenesis. AIDS 32:1599-1611
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

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