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 #
1U01AI068634-01
Application #
7068818
Study Section
Special Emphasis Panel (ZAI1-TS-A (J1))
Program Officer
Howell Simmonds, Kimberly
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2006-06-29
Budget End
2007-05-31
Support Year
1
Fiscal Year
2006
Total Cost
$14,780,954
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; Wilson, Michael R; Wu, Kunling et al. (2018) Stroke incidence is highest in women and non-Hispanic blacks living with HIV in the AIDS Clinical Trials Group Longitudinal Linked Randomized Trials cohort. AIDS 32:1125-1135
Moro, Ruth N; Scott, Nigel A; Vernon, Andrew et al. (2018) Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. Ann Am Thorac Soc 15:570-580
Hulgan, Todd; Ramsey, Benjamin S; Koethe, John R et al. (2018) Relationships between Adipose Mitochondrial Function, Serum Adiponectin, and Insulin Resistance in Persons with HIV after 96 weeks of Antiretroviral Therapy. J Acquir Immune Defic Syndr :
Grover, Surbhi; Desir, Fidel; Jing, Yuezhou et al. (2018) Reduced Cancer Survival Among Adults With HIV and AIDS-Defining Illnesses Despite No Difference in Cancer Stage at Diagnosis. J Acquir Immune Defic Syndr 79:421-429
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

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