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
Court, Richard; Gordon, Michelle; Cohen, Karen et al. (2016) Random lopinavir concentrations predict resistance on lopinavir-based antiretroviral therapy. Int J Antimicrob Agents 48:158-62
Li, Jonathan Z; Etemad, Behzad; Ahmed, Hayat et al. (2016) The size of the expressed HIV reservoir predicts timing of viral rebound after treatment interruption. AIDS 30:343-53
Treasure, Graham C; Aga, Evgenia; Bosch, Ronald J et al. (2016) Brief Report: Relationship Among Viral Load Outcomes in HIV Treatment Interruption Trials. J Acquir Immune Defic Syndr 72:310-3
Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko et al. (2016) Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet 387:1198-209
Rutstein, Sarah E; Hosseinipour, Mina C; Weinberger, Morris et al. (2016) Predicting resistance as indicator for need to switch from first-line antiretroviral therapy among patients with elevated viral loads: development of a risk score algorithm. BMC Infect Dis 16:280
Castillo-Mancilla, Jose R; Aquilante, Christina L; Wempe, Michael F et al. (2016) Pharmacogenetics of unboosted atazanavir in HIV-infected individuals in resource-limited settings: a sub-study of the AIDS Clinical Trials Group (ACTG) PEARLS study (NWCS 342). J Antimicrob Chemother 71:1609-18
Zhao, Lihui; Claggett, Brian; Tian, Lu et al. (2016) On the restricted mean survival time curve in survival analysis. Biometrics 72:215-21
Bedimo, Roger; Kang, Minhee; Tebas, Pablo et al. (2016) Effects of Pegylated Interferon/Ribavirin on Bone Turnover Markers in HIV/Hepatitis C Virus-Coinfected Patients. AIDS Res Hum Retroviruses 32:325-8
Hong, Feiyu; Aga, Evgenia; Cillo, Anthony R et al. (2016) Novel Assays for Measurement of Total Cell-Associated HIV-1 DNA and RNA. J Clin Microbiol 54:902-11
Kwara, Awewura; Enimil, Anthony; Gillani, Fizza S et al. (2016) Pharmacokinetics of First-Line Antituberculosis Drugs Using WHO Revised Dosage in Children With Tuberculosis With and Without HIV Coinfection. J Pediatric Infect Dis Soc 5:356-365

Showing the most recent 10 out of 282 publications