Great strides have been made in the treatment of human immunodeficiency virus (HIV) and the opportunistic infections (01) associated with acquired immune deficiency syndrome (AIDS) over the last 30 years, resulting in substantial reductions in AIDS associated morbidity and mortality throughout the world. The AIDS Clinical Trials Group (ACTG) has been at the forefront of these efforts for more than 25 years. Clinical trials and laboratory studies conducted by the ACTG have produced major insights that form the cornerstones of current guidelines and standards of clinical management of HIV-1 infection and its co-morbidities and complications. Despite this impressive progress, substantial challenges remain in key aspects of HIV therapeutics. These include: strategies for eradicating HIV or achieving functional cure;diagnosis, treatment and prevention of tuberculosis, including multidrug-resistant (MDR) TB in co-infected and mono-infected patients;developing more effective and better tolerated regimens for the treatment of viral hepatitis in co-infected and monoinfected patients;reducing the persistent immune activation that accompanies treated chronic HIV infection and preventing the associated co-morbidities;developing novel interventions targeting HIV;and improving the diagnosis, treatment and prevention of HlV-associated malignancies. The ACTG proposes a comprehensive research agenda that draws on an international consortium of leading clinical and laboratory HIV investigators in collaboration with a world-class Statistics and Data Management Center to design and conduct innovative interventional clinical trials that will significantly reduce the global burden of diseae due to HIV, TB and hepatitis.
Specific aims of the ACTG Network Leadership Group (LG) include: 1. The ACTG Leadership and Operations Center (LOC). A newly restructured LOC is proposed to provide scientific leadership and fiscal and organizational management of the ACTG. The ACTG Executive Committee (AEC) will serve as the overarching governing body of the network. Transformative Science Groups will oversee the development and execution of the ACTG research agenda, which will be coordinated and prioritized by the Scientific Agenda Steering Committee (SASC). Protocol development, implementation, training and network evaluation will be facilitated by the Network Coordinating Center at Social &Scientific Systems, Inc. The LOC financial management group at Brigham and Women's Hospital (BWH) will oversee resource management and protocol fund distribution at the direction of the AEC. The LOC will assure the engagement of Community in all aspects of the ACTG, and will coordinate communication between all three components of the network. 2. The ACTG Laboratory Center (LC). The ACTG LC will comprise Specialty Laboratories in virology, immunology, pharmacology, mycobacteriology and genomics equipped to perform protocol-specified testing and to advance the state-of-the-art by developing novel assays to address innovative pathogenesis-based questions arising from ACTG clinical trials. The LC will also oversee the quality management of all laboratories performing testing for clinical monitoring and primary endpoint determination. The LC leadership will be fully integrated into the scientific committee and governance structure of the LOC, assuring close alignment of LC activities with the research agenda of the network as a whole. Particular emphasis will be placed on building network laboratory capacity at international sites in resource-limited settings. 3. The ACTG Statistics and Data Management Center (SDMC). The SDMC will comprise the Statistical and Data Analysis Center (SDAC) at the Center for Biostatistics and AIDS Research (CBAR) at Harvard School of Public Health (HSPH) and the Data Management Center (DMC) at Frontier Science &Technology Research Foundation (FSTRF) in Amherst, NY. The SDMC will provide innovative approaches to the design and biostatistical analysis of ACTG clinical trials and laboratory studies;leads accurate collection of protocol specific clinical and laboratory data through electronic data capture;ensure data integrity, security and quality;and provide training to sites and laboratories. The SDMC will prepare regular reports to support the work of data monitoring committees overseeing the safety of ACTG trials. The SDMC leadership will be fully integrated into the scientific committee and governance structure of the LOC, assuring close alignment of SDMC activities with the research agenda of the network as a whole.

Public Health Relevance

The expertise provided by the SDMC will help advance research concerning the treatment of HIV-infected people or of diseases such as tuberculosis and hepatitis affecting these people. It will achieve this 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.

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 #
2UM1AI068634-08
Application #
8555001
Study Section
Special Emphasis Panel (ZAI1-PRJ-A (S1))
Program Officer
Ojumu, Akinlolu O
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2014-01-01
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$11,389,724
Indirect Cost
$2,431,920
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
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