Abstract

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 ? ? ?

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI068634-03
Application #
7489484
Study Section
Special Emphasis Panel (ZAI1-TS-A (J1))
Program Officer
Ojumu, Akinlolu O
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2008-06-01
Budget End
2009-05-31
Support Year
3
Fiscal Year
2008
Total Cost
$14,259,739
Indirect Cost

  Institution

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

  Publications

Chow, Felicia C; Makanjuola, Akintomiwa; Wu, Kunling et al. (2018) Physical activity is associated with lower odds of cognitive impairment in women but not men living with HIV infection. J Infect Dis :
Bares, Sara H; Smeaton, Laura M; Xu, Ai et al. (2018) HIV-Infected Women Gain More Weight than HIV-Infected Men Following the Initiation of Antiretroviral Therapy. J Womens Health (Larchmt) 27:1162-1169
Hart, Stephen A; Vardhanabhuti, Saran; Strobino, Sarah A et al. (2018) Impact of Changes Over Time in the Stanford University Genotypic Resistance Interpretation Algorithm. J Acquir Immune Defic Syndr 79:e21-e29
Angelidou, Konstantia; Hunt, Peter W; Landay, Alan L et al. (2018) Changes in Inflammation but Not in T-Cell Activation Precede Non-AIDS-Defining Events in a Case-Control Study of Patients on Long-term Antiretroviral Therapy. J Infect Dis 218:239-248
Namazi, Golnaz; Fajnzylber, Jesse M; Aga, Evgenia et al. (2018) The Control of HIV After Antiretroviral Medication Pause (CHAMP) Study: Posttreatment Controllers Identified From 14 Clinical Studies. J Infect Dis 218:1954-1963
Archary, Moherndran; Mcllleron, Helen; Bobat, Raziya et al. (2018) Population Pharmacokinetics of Lopinavir in Severely Malnourished HIV-infected Children and the Effect on Treatment Outcomes. Pediatr Infect Dis J 37:349-355
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:
Kallianpur, Asha R; Gerschenson, Mariana; Hulgan, Todd et al. (2018) Hemochromatosis (HFE) Gene Variants Are Associated with Increased Mitochondrial DNA Levels During HIV-1 Infection and Antiretroviral Therapy. AIDS Res Hum Retroviruses 34:942-949
AIDS-defining Cancer Project Working Group of IeDEA, COHERE in EuroCoord (2018) Non-Hodgkin lymphoma risk in adults living with HIV across five continents. AIDS 32:2777-2786
Sharaf, Radwa; Lee, Guinevere Q; Sun, Xiaoming et al. (2018) HIV-1 proviral landscapes distinguish posttreatment controllers from noncontrollers. J Clin Invest 128:4074-4085

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