This application describes the Chinese Clinical Trials Unit on HIV Research (CCTU) and its capacity to serve as a Clinical Trials Unit (CTU) for the NIAID clinical research networks. Though widely noted for the rapid scale up and success of HIV treatment and prevention services, China faces ongoing public health challenges surrounding HIV. Its unique epidemic profile offers opportunities to examine the following research topics: - As part of the HIV Prevention Trials Network (HPTN), assess the 1) acceptability and feasibility of early antiretroviral treatment as a prevention strategy in HIV serodiscordant couples, 2) feasibility and efficacy of an enhanced test, link, and care strategy to reduce HIV transmission in urban MSM and to improve STI treatment uptake in FSW, and 3) acceptability and adherence to approved PrEP regimens among MSM in China; - As part of the HIV Vaccine Trials Network (HVTN), evaluate 1) the safety and efficacy of poxvirus-protein combination vaccine candidates among high HIV-incidence risk groups, 2) specifically evaluate safety and efficacy of prime-boost vaccine strategies utilizing the Chinese-developed vaccinia plasmid vector rTV and collaborator protein candidates, and 3) assess the feasibility, safety, and efficacy of combined vaccine and PrEP approaches; - As part of the AIDS Clinical Trials Group (ACTG), to investigate 1) optimal regimens, timing, and efficacy of new drugs for HIV/Hepatitis co-infection as well as their interaction with HAART drugs, and 2) efficacy of integrated strategies to prevent and treat co-morbidities, including TB, diabetes, and other noncommunicable co-morbidities in diverse patients, including elderly patients. CCTU will consist of up to 6 Clinical Research Sites (CRSs), which represent the diverse range China's at-risk and patient population structures and viral diversity. The outcomes of CCTU's research will be widely applicable to national, regional, and global efforts on HIV/AIDS prevention and control.
Given China's large population size, rapid pace of development, and concentrated HIV/AIDS epidemic, the treatment and prevention lessons learned here will be of great relevance for global disease control efforts, particularly in resourc-constrained settings. China's unique epidemic profile and research capacities allow for investigations on a range of typically difficult-to-reach patient populations and at-risk groups.
|Metzger, David S; Donnell, Deborah; Celentano, David D et al. (2015) Expanding substance use treatment options for HIV prevention with buprenorphine-naloxone: HIV Prevention Trials Network 058. J Acquir Immune Defic Syndr 68:554-61|
|Jackson, J Brooks; Wei, Liu; Liping, Fu et al. (2014) Prevalence and seroincidence of hepatitis B and hepatitis C infection in high risk people who inject drugs in china and Thailand. Hepat Res Treat 2014:296958|
|Hulgan, Todd; Stein, James H; Cotter, Bruno R et al. (2013) Mitochondrial DNA variation and changes in adiponectin and endothelial function in HIV-infected adults after antiretroviral therapy initiation. AIDS Res Hum Retroviruses 29:1293-9|
|Wohl, David A; Kendall, Michelle A; Feinberg, Judith et al. (2013) The clinical impact of continuing to prescribe antiretroviral therapy in patients with advanced AIDS who manifest no virologic or immunologic benefit. PLoS One 8:e78676|
|Bronke, Corine; Almeida, Coral-Ann M; McKinnon, Elizabeth et al. (2013) HIV escape mutations occur preferentially at HLA-binding sites of CD8 T-cell epitopes. AIDS 27:899-905|
|Huang, Jeannie S; Hughes, Michael D; Riddler, Sharon A et al. (2013) Bone mineral density effects of randomized regimen and nucleoside reverse transcriptase inhibitor selection from ACTG A5142. HIV Clin Trials 14:224-34|
|Carlson, Jonathan M; Brumme, Chanson J; Martin, Eric et al. (2012) Correlates of protective cellular immunity revealed by analysis of population-level immune escape pathways in HIV-1. J Virol 86:13202-16|
|Kang, M; Cu-Uvin, S (2012) Association of HIV viral load and CD4 cell count with human papillomavirus detection and clearance in HIV-infected women initiating highly active antiretroviral therapy. HIV Med 13:372-8|
|Haubrich, Richard H; Riddler, Sharon A; Ribaudo, Heather et al. (2011) Initial viral decay to assess the relative antiretroviral potency of protease inhibitor-sparing, nonnucleoside reverse transcriptase inhibitor-sparing, and nucleoside reverse transcriptase inhibitor-sparing regimens for first-line therapy of HIV infection AIDS 25:2269-78|
|Umeh, Obi C; Currier, Judith S; Park, Jeong-Gun et al. (2011) Sex differences in lopinavir and ritonavir pharmacokinetics among HIV-infected women and men. J Clin Pharmacol 51:1665-73|
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