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

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI068634-07
Application #
8268981
Study Section
Special Emphasis Panel (ZAI1-TS-A (J1))
Program Officer
Ojumu, Akinlolu O
Project Start
2006-06-29
Project End
2013-12-31
Budget Start
2012-06-01
Budget End
2013-12-31
Support Year
7
Fiscal Year
2012
Total Cost
$15,061,511
Indirect Cost
$3,527,384
Name
Harvard University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02115
Jennings, Cheryl; Wager, Carrie G; Scianna, Salvatore R et al. (2018) Use of External Quality Control Material for HIV-1 RNA Testing To Assess the Comparability of Data Generated in Separate Laboratories and the Stability of HIV-1 RNA in Samples after Prolonged Storage. J Clin Microbiol 56:
Benson, Constance A; Andersen, Janet W; Macatangay, Bernard J C et al. (2018) Safety and Immunogenicity of Zoster Vaccine Live in Human Immunodeficiency Virus-Infected Adults With CD4+ Cell Counts >200 Cells/mL Virologically Suppressed on Antiretroviral Therapy. Clin Infect Dis 67:1712-1719
Gandhi, Monica; Gandhi, Rajesh T; Stefanescu, Andrei et al. (2018) Cumulative Antiretroviral Exposure Measured in Hair Is Not Associated With Measures of HIV Persistence or Inflammation Among Individuals on Suppressive ART. J Infect Dis 218:234-238
Stringer, Elizabeth M; Kendall, Michelle A; Lockman, Shahin et al. (2018) Pregnancy outcomes among HIV-infected women who conceived on antiretroviral therapy. PLoS One 13:e0199555
Kelesidis, Theodoros; Kendall, Michelle A; Danoff, Ann et al. (2018) Soluble levels of receptor for advanced glycation endproducts and dysfunctional high-density lipoprotein in persons infected with human immunodeficiency virus: ACTG NWCS332. Medicine (Baltimore) 97:e10955
MacBrayne, Christine E; Marks, Kristen M; Fierer, Daniel S et al. (2018) Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother 73:2112-2119
Hong, Feiyu; Jacobs, Jana L; Aga, Evgenia et al. (2018) Associations between HIV-1 DNA copy number, proviral transcriptional activity, and plasma viremia in individuals off or on suppressive antiretroviral therapy. Virology 521:51-57
Tweed, Conor Duncan; Wills, Genevieve Helen; Crook, Angela M et al. (2018) Liver toxicity associated with tuberculosis chemotherapy in the REMoxTB study. BMC Med 16:46
Murthy, S E; Chatterjee, F; Crook, A et al. (2018) Pretreatment chest x-ray severity and its relation to bacterial burden in smear positive pulmonary tuberculosis. BMC Med 16:73
Wyles, David L; Kang, Minhee; Matining, Roy M et al. (2018) Similar Low Rates of HCV Recurrence in HCV/HIV- and HCV-Infected Participants who Achieved SVR After DAA Treatment: Interim Results From the ACTG A5320 Viral Hepatitis C Infection Long-term Cohort Study (V-HICS). Open Forum Infect Dis 5:ofy103

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