The Ohio State University (OSU) AIDS Clinical Trials Unit (ACTU) plans to conduct clinical research that will increase knowledge about the pathogenesis, prevention, course, and treatment of HIV infection and its associated complications through affiliation by prior agreement with the AIDS Clinical Trials Group (ACTG) led by Dr. Constance Benson of the University of California, San Diego, CA and also proposes to affiliate with the HIV Vaccine Trials Network (HVTN) led by Dr. Lawrence Corey of the University of Washington, Seattle WA. Clinical trials will be designed and implemented: 1) to optimize the clinical management of HIV and its related complications;2) to evaluate agents with novel mechanisms of action or improved toxicity profiles for the treatment of HIV and/or for major copathogens (such as tuberculosis and hepatitis);3) to evaluate the safety, immunogenicity, and efficacy of multiple candidate HIV vaccines and adjuvants;4) to develop means of reducing HIV transmission by integrating HIV treatment with prevention efforts that evaluate practical behavioral interventions and other methods of transmission interruption;and 5) to minimize the risk of vertical transmission by maximizing care of HIV-infected women during their child-bearing years. HIV-infected individuals from a wide spectrum of ages, communities and socio-economic conditions will be recruited, screened and enrolled in specific protocols that address these high priority research areas at the OSU ACTU. Coordination of research related activities and timely execution of new studies will take advantage of established investigator expertise, ongoing productive partnerships with scientist colleagues and the HIV-infected community and a clinical research infrastructure that is recognized for its productivity in the ACTG over the past 18 years and more recently in large scale vaccine and prevention trials. Experienced research staff (investigators, nurses, pharmacy, data management, laboratory and outreach personnel) will recruit, screen, enroll and rummage all essential and required elements of clinical trials participation. Clinical research that develops and tests strategies and new treatments for HIV infection and its complications is critically important for controlling HIV disease progression and minimizing side effects. Well-designed clinical trials to test vaccines and other preventive strategies are essential to preventing the spread of HIV infection. ADMINISTRATIVE COMPONENT:

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-AR-A (M1))
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Adedeji, Bola
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Ohio State University
Internal Medicine/Medicine
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United States
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Leger, Paul D; Johnson, Daniel H; Robbins, Gregory K et al. (2014) Genome-wide association study of peripheral neuropathy with D-drug-containing regimens in AIDS Clinical Trials Group protocol 384. J Neurovirol 20:304-8
Wyatt, Christina M; Kitch, Douglas; Gupta, Samir K et al. (2014) Changes in proteinuria and albuminuria with initiation of antiretroviral therapy: data from a randomized trial comparing tenofovir disoproxil fumarate/emtricitabine versus abacavir/lamivudine. J Acquir Immune Defic Syndr 67:36-44
Haas, David W; Kwara, Awewura; Richardson, Danielle M et al. (2014) Secondary metabolism pathway polymorphisms and plasma efavirenz concentrations in HIV-infected adults with CYP2B6 slow metabolizer genotypes. J Antimicrob Chemother 69:2175-82
Cillo, Anthony R; Krishnan, Supriya; McMahon, Deborah K et al. (2014) Impact of chemotherapy for HIV-1 related lymphoma on residual viremia and cellular HIV-1 DNA in patients on suppressive antiretroviral therapy. PLoS One 9:e92118
Johnson, Daniel H; Venuto, Charles; Ritchie, Marylyn D et al. (2014) Genomewide association study of atazanavir pharmacokinetics and hyperbilirubinemia in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 24:195-203
Touzard Romo, F; Smeaton, L M; Campbell, T B et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverse, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials 15:246-60
Jacobson, Jeffrey M; Wang, Hongying; Bordi, Rebeka et al. (2014) A randomized controlled trial of palifermin (recombinant human keratinocyte growth factor) for the treatment of inadequate CD4+ T-lymphocyte recovery in patients with HIV-1 infection on antiretroviral therapy. J Acquir Immune Defic Syndr 66:399-406
Safren, Steven A; Biello, Katie B; Smeaton, Laura et al. (2014) Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial. PLoS One 9:e104178
Thio, Chloe L; Smeaton, Laura; Saulynas, Melissa et al. (2013) Characterization of HIV-HBV coinfection in a multinational HIV-infected cohort. AIDS 27:191-201
Ribaudo, Heather J; Daar, Eric S; Tierney, Camlin et al. (2013) Impact of UGT1A1 Gilbert variant on discontinuation of ritonavir-boosted atazanavir in AIDS Clinical Trials Group Study A5202. J Infect Dis 207:420-5

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