This application is a proposal to serve as the Statistical and Data Management Center (SDMC) of the AIDS Clinical Trials Group (ACTG), in affiliation with the ACTG Leadership Group headed by Dr. Constance A. Benson (UCSD). The ACTG is proposing a therapeutic research agenda to address objectives in the NIAID high priority research areas of Translational Research/Drug Development;Optimization of Clinical Management;Vaccine Research and Development;Prevention of Mother-to-Child Transmission of HIV Infection;and Prevention of HIV. In addition, the ACTG is applying for funding to carry out research in the NIDCR priority area.
Our Specific Aims are to support the research agenda of the ACTG by providing a group of highly experienced statisticians, data managers and other professionals who are knowledgeable in all aspects of HIV therapeutic research and an organizational structure that promotes this work with the ACTG;to provide expertise and high quality clinical and laboratory data management and communications systems to support the development, conduct and analysis of ACTG studies;and to advance the mission of the ACTG through innovation in study design and analysis, providing leadership in cross-study analyses and collaborating effectively with other HIV Trials Networks and HIV research organizations. The expertise provided by the SDMC will help advance HIV therapeutic research by ensuring that ACTG clinical trials and other studies are efficiently designed and analyzed to the highest standards. This research will continue to make significant contributions in advancing optimal treatment of HIV-infected individuals both in the Unites States and internationally. Translational Research/Drug Development

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-TS-A (J1))
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Ojumu, Akinlolu O
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Harvard University
Biostatistics & Other Math Sci
Schools of Public Health
United States
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Vardhanabhuti, Saran; Taiwo, Babafemi; Kuritzkes, Daniel R et al. (2015) Phylogenetic evidence of HIV-1 sequence evolution in subjects with persistent low-level viraemia. Antivir Ther 20:73-6
Havers, Fiona; Smeaton, Laura; Gupte, Nikhil et al. (2014) 25-Hydroxyvitamin D insufficiency and deficiency is associated with HIV disease progression and virological failure post-antiretroviral therapy initiation in diverse multinational settings. J Infect Dis 210:244-53
Erlandson, Kristine Mace; Kitch, Douglas; Tierney, Camlin et al. (2014) Impact of randomized antiretroviral therapy initiation on glucose metabolism. AIDS 28:1451-61
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
Shaffer, Douglas; Hughes, Michael D; Sawe, Fredrick et al. (2014) Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE). J Acquir Immune Defic Syndr 66:155-63
Shiboski, C H; Chen, H; Ghannoum, M A et al. (2014) Role of oral candidiasis in TB and HIV co-infection: AIDS Clinical Trial Group Protocol A5253. Int J Tuberc Lung Dis 18:682-8
Luetkemeyer, Anne F; Kendall, Michelle A; Nyirenda, Mulinda et al. (2014) Tuberculosis immune reconstitution inflammatory syndrome in A5221 STRIDE: timing, severity, and implications for HIV-TB programs. J Acquir Immune Defic Syndr 65:423-8
Gillespie, Stephen H; Crook, Angela M; McHugh, Timothy D et al. (2014) Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med 371:1577-87
Sandler, Netanya G; Zhang, Xinyan; Bosch, Ronald J et al. (2014) Sevelamer does not decrease lipopolysaccharide or soluble CD14 levels but decreases soluble tissue factor, low-density lipoprotein (LDL) cholesterol, and oxidized LDL cholesterol levels in individuals with untreated HIV infection. J Infect Dis 210:1549-54
Kantor, Rami; Bettendorf, Daniel; Bosch, Ronald J et al. (2014) HIV-1 RNA levels and antiretroviral drug resistance in blood and non-blood compartments from HIV-1-infected men and women enrolled in AIDS clinical trials group study A5077. PLoS One 9:e93537

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