ABSTRACT 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 over 30 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 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: antiretroviral therapy (ART) free HIV remission, 2) novel therapeutics targeting HIV, 3) tuberculosis, and 4) HIV co-morbidities, including neurologic complications and hepatitis B cure. The continued expansion of an effective, quality-assured laboratory program at domestic and international sites for protocol safety measures, state-of-the-art assays for virology and tuberculosis, immunology and biomarkers, pharmacology, and genomics 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 support the laboratory training of technologists and investigators domestically and internationally.

NARRATIVE 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 Hepatitis B, transforming the treatment of patients with these infections. The clinical research conducted by the ACTG will lead to significantly reduced morbidity and mortality, particularly among populations disproportionately affected by HIV/AIDS and tuberculosis.