This application requests renewal of funding to serve as the Statistical and Data Management Center of the AIDS Clinical Trials Group (ACTG). The ACTG is an international clinical trials network which is proposing to address objectives in NIAID high priority research areas for adults living with HIV. Specifically: to evaluate novel and durable interventions targeting HIV infection; to identify strategies to reduce HIV reservoirs and control HIV replication in the absence of ART (?ART-free remission?); to improve the diagnosis and treatment of tuberculosis, especially in those co-infected with HIV; and to improve the prevention and treatment of co-morbidities and co-infections, including curative strategies hepatitis B virus co-infection. The application's specific aims and long-term objectives are: to support the international research agenda of the ACTG by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who have a deep interest in research in HIV infection and its complications and co-infections; to support the development, conduct and analysis of ACTG studies with expert statistical and data management leadership and high quality clinical and laboratory data management and communications systems which comply with regulatory requirements, meet industry standards and are fully integrated into quality management system workflows; and to advance the mission of the ACTG through innovation in study design and analysis and the development of efficient methods and systems, that facilitate the work of the ACTG and promote harmonization and data sharing with collaborating organizations. The proposed SDMC consists of two components. One is a Statistical and Data Analysis Center at Harvard T.H. Chan School of Public Health which will provide biostatistical leadership, and includes a subcontract to University of California San Francisco to support additional tuberculosis trial design expertise. The second is a Data Management Center at Frontier Science & Technology Research Foundation which will provide expertise and leadership in data management systems, and has primary responsibility for data collection, quality and integrity.

Public Health Relevance

The expertise provided by the SDMC will help advance research concerning the treatment of adults living with HIV and co-infections such as tuberculosis and hepatitis B virus. It will achieve this by ensuring that ACTG clinical trials and other studies are designed, conducted, and analyzed efficiently and to the highest standards using state-of-the-art, compliant clinical and laboratory information management systems that ensure complete and high-quality data. This research will continue to make significant contributions in advancing optimal treatment of people living with HIV both in the United States and internationally.

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 #
2UM1AI068634-15
Application #
9987138
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Ojumu, Akinlolu O
Project Start
2006-06-29
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
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
Akpa, Onoja; Miyahara, Sachiko; Taiwo, Babafemi et al. (2018) Similar changes in neuropsychological functioning in english and spanish speaking HIV patients. Brain Behav 8:e01083
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
Wilkin, Timothy J; Chen, Huichao; Cespedes, Michelle S et al. (2018) A Randomized, Placebo-Controlled Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Adults Aged 27 Years or Older: AIDS Clinical Trials Group Protocol A5298. Clin Infect Dis 67:1339-1346
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
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
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:
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
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
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
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

Showing the most recent 10 out of 439 publications