The AIDS Clinical Trials Group (ACTG) has been at the forefront of clinical research to advance HIV therapeutics and improve the health of patients living with HIV/AIDS for 25 years. Rigorous scientific research conducted by the ACTG has laid the cornerstones for current HIV treatment guidelines. In this application for the competitive renewal of the ACTG Network Laboratory Center, we propose a transformative laboratory research agenda that draws on an international consortium of prominent clinical and laboratory investigators in collaboration with a world-class Statistical and Data Management Center to conduct leading edge laboratory research, testing, assay development and laboratory training for the support of innovative interventional clinical trials. The component ACTG Network Laboratory Center will improve scientific knowledge and technical capability by providing state-of-the-art laboratory support in the four NIH/DAIDS priority areas of strategies to cure HIV; improve the diagnosis and treatment of tuberculosis; identify strategies to cure infectious viral hepatitis; improve the treatment and prevention of non-infectious co-morbidities associated with HIV infection and evaluate novel interventions targeting HIV infection. In addition, the Laboratory Center will provide laboratory support for therapeutic studies of oral manifestations of HIV/AIDS and virally mediated cancers. The continued expansion of an effective, quality-assured laboratory program at domestic and international sites for protocol safety measures, state-of-the-art molecular assays for virology and mycobacteriology; immunology and biomarkers; pharmacology; genomics; and oral pathogens associated with HIV-1 infection, will provide the essential framework for advancing the scientific agenda of the ACTG Network. The Laboratory Center will continue to provide oversight of established specimen and human DNA repositories for the ACTG Network, harmonize specific laboratory testing and standardized operating procedures with other Networks where feasible and continue to support the laboratory training of technologists and investigators domestically and internationally.

Public Health Relevance

The laboratory studies proposed in this application will have a direct beneficial effect on the health of millions of patients worldwide who are infected with HIV, TB and viral hepatitis, transforming the treatment of patients with these infections. The clinical research conducted by the ACTG will lead to significantly reducing morbidity and mortality, particularly among populations disproportionately affected by HIV/AIDS and tuberculosis

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 #
5UM1AI106701-02
Application #
8782606
Study Section
Special Emphasis Panel (ZAI1-PRJ-A (S1))
Program Officer
Livnat, Daniella
Project Start
2014-01-01
Project End
2020-11-30
Budget Start
2014-12-01
Budget End
2015-11-30
Support Year
2
Fiscal Year
2015
Total Cost
$6,509,496
Indirect Cost
$418,414
Name
Brigham and Women's Hospital
Department
Type
DUNS #
030811269
City
Boston
State
MA
Country
United States
Zip Code
02115
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