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3. Local Chirality of Low-Lying Dirac Eigenmodes and the Instanton Liquid Model

Author

Horvath, I., Dong, S. J., Draper, T., Isgur, N., Lee, F. X., Liu, K. F., McCune, J., Thacker, H. B., and Zhang, J. B.

Subjects
High Energy Physics - Lattice, High Energy Physics - Phenomenology, High Energy Physics - Theory, Nuclear Theory
Abstract

The reasons for using low-lying Dirac eigenmodes to probe the local structure of topological charge fluctuations in QCD are discussed, and it is pointed out that the qualitative double-peaked behavior of the local chiral orientation probability distribution in these modes is necessary, but not sufficient for dominance of instanton-like fluctuations. The results with overlap Dirac operator in Wilson gauge backgrounds at lattice spacings ranging from a~0.04 fm to a~0.12 fm are reported, and it is found that the size and density of local structures responsible for double-peaking of the distribution are in disagreement with the assumptions of the Instanton Liquid Model. More generally, our results suggest that vacuum fluctuations of topological charge are not effectively dominated by locally quantized (integer-valued) lumps in QCD., Comment: 29 pages, 13 figures; v2: minor improvements in presentation, results and conclusions unchanged, version to appear in PRD

Published
2002
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4. Topological Charge Fluctuations and Low-Lying Dirac Eigenmodes

Author

Dong, S. J., Draper, T., Horvath, I., Isgur, N., Lee, F. X., McCune, J., Zhang, J. B., and Thacker, H. B.

Subjects
High Energy Physics - Lattice, High Energy Physics - Phenomenology, Nuclear Theory
Abstract

We discuss the utility of low-lying Dirac eigenmodes for studying the nature of topological charge fluctuations in QCD. The implications of previous results using the local chirality histogram method are discussed, and the new results using the overlap Dirac operator in Wilson gauge backgrounds at lattice spacings ranging from a~0.04 fm to a~0.12 fm are reported. While the degree of local chirality does not change appreciably closer to the continuum limit, we find that the size and density of local structures responsible for chiral peaking do change significantly. The resulting values are in disagreement with the assumptions of the Instanton Liquid Model. We conclude that the fluctuations of topological charge in the QCD vacuum are not locally quantized., Comment: 3 pages, 4 figures, Lattice2001(confinement)

Published
2001
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5. AIDS Vaccine Development

Author

Agosto, Moises, Allan, Jon, Benson, Constance, Berger, Edward A., Blumenthal, Robert, Burton, Dennis, Clements, Janice, Coffin, John, Connor, Ruth, Cullen, Bryan, Desrosiers, Ronald, Dimitrov, Dimiter, Doms, Robert, Emerman, Michael, Feinberg, Mark, Fultz, Patricia, Gerard, Craig, Gonsalves, Gregg, Haase, Ashley, Haigwood, Nancy, Hirsch, Vanessa, Ho, David, Hoxie, James A., Hu, Shiu-Lok, Hunter, Eric, Johnson, Philip, Kawata, Paul Akio, Korber, Bette, Kuiken, Carla, Learn, Gerald H., Leitner, Thomas, Lewis, George, Link, Derek, Luban, Jeremy, Luzuriaga, Katherine, Malim, Michael, Marx, Preston, McCune, J. M., Montefiori, David, Moore, John, Morrow, Casey, Mosier, Donald, Muesing, Mark, Nixon, Douglas, Nunberg, Jack, Overbaugh, Julie, Parren, Paul, Planelles, Vincente, Pope, Melissa, Posnett, David N., Siliciano, Robert, Steinman, Ralph, Stevenson, Mario, Swanstrom, Ronald, Walker, Bruce D., Wolinsky, Steven, Zingale, Daniel, and Lévy, Jean-Paul

Published
1998

9. Computational Methods for Parachute Aerodynamics

Author

Tezduyar, T., Osawa, Y., Stein, K., Benney, R., Kumar, V., McCune, J., Hirschel, Ernst Heinrich, editor, Fujii, Kozo, editor, Haase, Werner, editor, van Leer, Bram, editor, Leschziner, Michael A., editor, Pandolfi, Maurizio, editor, Periaux, Jacques, editor, Rizzi, Arthur, editor, Roux, Bernard, editor, Hafez, Mohamed, and Morinishi, Koji

Published
2001
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15. European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria item performance

Author

Aringer, M. Brinks, R. Dörner, T. Daikh, D. Mosca, M. Ramsey-Goldman, R. Smolen, J.S. Wofsy, D. Boumpas, D.T. Kamen, D.L. Jayne, D. Cervera, R. Costedoat-Chalumeau, N. Diamond, B. Gladman, D.D. Hahn, B. Hiepe, F. Jacobsen, S. Khanna, D. Lerstrøm, K. Massarotti, E. McCune, J. Ruiz-Irastorza, G. Sanchez-Guerrero, J. Schneider, M. Urowitz, M. Bertsias, G. Hoyer, B.F. Leuchten, N. Schmajuk, G. Tani, C. Tedeschi, S.K. Touma, Z. Anic, B. Assan, F. Chan, T.M. Clarke, A.E. Crow, M.K. Czirják, L. Doria, A. Graninger, W. Halda-Kiss, B. Hasni, S. Izmirly, P.M. Jung, M. Kumánovics, G. Mariette, X. Padjen, I. Pego-Reigosa, J.M. Romero-Diaz, J. Rúa-Figueroa, I. Seror, R. Stummvoll, G.H. Tanaka, Y. Tektonidou, M.G. Vasconcelos, C. Vital, E.M. Wallace, D.J. Yavuz, S. Meroni, P.L. Fritzler, M.J. Naden, R. Costenbader, K. Johnson, S.R.

Subjects
musculoskeletal diseases, immune system diseases, skin and connective tissue diseases
Abstract

Background/objectives The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus system showed high specificity, while attaining also high sensitivity. We hereby analysed the performance of the individual criteria items and their contribution to the overall performance of the criteria. Methods We combined the EULAR/ACR derivation and validation cohorts for a total of 1197 systemic lupus erythematosus (SLE) and n=1074 non-SLE patients with a variety of conditions mimicking SLE, such as other autoimmune diseases, and calculated the sensitivity and specificity for antinuclear antibodies (ANA) and the 23 specific criteria items. We also tested performance omitting the EULAR/ACR criteria attribution rule, which defines that items are only counted if not more likely explained by a cause other than SLE. Results Positive ANA, the new entry criterion, was 99.5% sensitive, but only 19.4% specific, against a non-SLE population that included other inflammatory rheumatic, infectious, malignant and metabolic diseases. The specific criteria items were highly variable in sensitivity (from 0.42% for delirium and 1.84% for psychosis to 75.6% for antibodies to double-stranded DNA), but their specificity was uniformly high, with low C3 or C4 (83.0%) and leucopenia 80% for all items, explaining the higher overall specificity of the criteria set. © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Published
2021

23. Performance of the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus in early disease, across sexes and ethnicities

Author

Johnson, S.R. Brinks, R. Costenbader, K.H. Daikh, D. Mosca, M. Ramsey-Goldman, R. Smolen, J.S. Wofsy, D. Boumpas, D.T. Kamen, D.L. Jayne, D. Cervera, R. Costedoat-Chalumeau, N. Diamond, B. Gladman, D.D. Hahn, B. Hiepe, F. Jacobsen, Sø. Khanna, D. Lerstrøm, K. Massarotti, E. McCune, J. Ruiz-Irastorza, G. Sanchez-Guerrero, J. Schneider, M. Urowitz, M. Bertsias, G. Hoyer, B.F. Leuchten, N. Tani, C. Tedeschi, S.K. Touma, Z. Schmajuk, G. Anic, B. Assan, F. Chan, T.M. Clarke, A.E. Crow, M.K. Czirják, L. Doria, A. Graninger, W.B. Halda-Kiss, B. Hasni, S. Izmirly, P.M. Jung, M. Kumánovics, G. Mariette, X. Padjen, I. Pego-Reigosa, J.M. Romero-Diaz, J. Rúa-Figueroa, Í. Seror, R. Stummvoll, G.H. Tanaka, Y. Tektonidou, M.G. Vasconcelos, C. Vital, E.M. Wallace, D.J. Yavuz, S. Meroni, P.L. Fritzler, M.J. Naden, R. Dörner, T. Aringer, M.

Subjects
musculoskeletal diseases, immune system diseases, skin and connective tissue diseases
Abstract

Objectives The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 Classification Criteria for systemic lupus erythematosus (SLE) have been validated with high sensitivity and specificity. We evaluated the performance of the new criteria with regard to disease duration, sex and race/ethnicity, and compared its performance against the Systemic Lupus International Collaborating Clinics (SLICC) 2012 and ACR 1982/1997 criteria. Methods Twenty-one SLE centres from 16 countries submitted SLE cases and mimicking controls to form the validation cohort. The sensitivity and specificity of the EULAR/ACR 2019, SLICC 2012 and ACR 1982/1997 criteria were evaluated. Results The cohort consisted of female (n=1098), male (n=172), Asian (n=118), black (n=68), Hispanic (n=124) and white (n=941) patients; with an SLE duration of 1 to

Published
2020

24. HIV-Infected Liver and Kidney Transplant Recipients: 1- and 3-Year Outcomes: Good transplant and HIV-related outcomes among HIV-infected kidney recipients, and reasonable outcomes among liver transplant recipients, suggest that transplantation is an option for selected HIV-infected patients cared for at centers with adequate expertise.

Author

Roland, M. E., Barin, B., Carlson, L., Frassetto, L. A., Terrault, N. A., Hirose, R., Freise, C. E., Benet, L. Z., Ascher, N. L., Roberts, J. P., Murphy, B., Keller, M. J., Olthoff, K. M., Blumberg, E. A., Brayman, K. L., Bartlett, S. T., Davis, C. E., McCune, J. M., Bredt, B. M., Stablein, D. M., and Stock, P. G.

Published
2008

26. International AIDS Society global scientific strategy: towards an HIV cure 2016

Author

Deeks, Sg, Lewin, Sr, Ross, Al, Ananworanich, J, Benkirane, M, Cannon, P, Chomont, N, Douek, D, Lifson, Jd, Lo, Yr, Kuritzkes, D, Margolis, D, Mellors, J, Persaud, D, Tucker, Jd, Barre-Sinoussi, F, International Aids Society Towards a Cure Working Group, International Aids Society Towards a Cure Working Group, Alter, G, Auerbach, J, Autran, B, Barouch, Dh, Behrens, G, Cavazzana, M, Chen, Z, Cohen, Ea, Corbelli, Gm, Eholié, S, Eyal, N, Fidier, S, Garcia, L, Grossman, C, Henderson, G, Henrich, Tj, Jefferys, R, Kiem, Hp, Mccune, J, Moodley, K, Newman, Pa, Nijhuis, M, Nsubuga, Ms, Ott, M, Palmer, S, Richman, D, Saez-Cirion, A, Sharp, M, Siliciano, J, Silvestri, G, Singh, J, Spire, B, Taylor, J, Tolstrup, M, Valente, S, van Lunzen, J, Walensky, R, Wilson, I, Zack, J, Department of Medicine [San Francisco], University of California [San Francisco] (UC San Francisco), University of California (UC)-University of California (UC), The Peter Doherty Institute for Infection and Immunity [Melbourne], University of Melbourne-The Royal Melbourne Hospital, Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Australia, International and Scientific Relations Office, ANRS, Paris, France, Walter Reed Army Institute of Research, Institut de génétique humaine (IGH), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), University of Southern California (USC), Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CR CHUM), Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal (UdeM)-Université de Montréal (UdeM), National Institutes of Health [Bethesda] (NIH), Frederick National Laboratory for Cancer Research (FNLCR), World Health Organization Regional Office for the Western Pacific, Manila, Philippines, Brigham and Women's Hospital [Boston], University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC), University of Pittsburgh School of Medicine, Pennsylvania Commonwealth System of Higher Education (PCSHE), Johns Hopkins Bloomberg School of Public Health [Baltimore], Johns Hopkins University (JHU), Institut Pasteur [Paris] (IP), Ragon Institute of MGH, MIT and Harvard, Centre d'Immunologie et de Maladies Infectieuses (CIMI), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Beth Israel Deaconess Medical Center [Boston] (BIDMC), Harvard Medical School [Boston] (HMS), Clinic for Immunology and Rhematology, Hannover Medical School, Hanover, Germany, Département de Biothérapie [CHU Necker], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AIDS Institute, The University of Hong Kong, Pok Fu Lam, Hong Kong, Institut de Recherches Cliniques de Montréal (IRCM), Université de Montréal (UdeM), European AIDS Treatment Group, Italy, Programme PAC-CI, Centre Hospitalier Universitaire de Treichville, Abidjan, Côte d'Ivoire, Harvard School of Public Health, Imperial College London, The B-Change Group, Manila, Philippines, Treatment Action Group (TAG), Fred Hutchinson Cancer Research Center [Seattle] (FHCRC), Stellenbosch University, Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, Ontario, Canada, University Medical Center [Utrecht], Joint Clinical Research Centre, University of California (UC), The Westmead Institute for Medical Research, University of California [San Diego] (UC San Diego), Independent HIV Education and Advocacy Consultant, San Francisco, California, USA, Emory University [Atlanta, GA], Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U912 INSERM - Aix Marseille Univ - IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), CARE Collaboratory Community Advisory Board, Palm Springs, California, USA., Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark., The Scripps Research Institute [La Jolla, San Diego], ViiV Healthcare, London, United Kingdom., Massachusetts General Hospital [Boston], Brown University School of Public Health, David Geffen School of Medicine [Los Angeles], University of California [Los Angeles] (UCLA), University of California [San Francisco] (UCSF), University of California-University of California, Institut Pasteur [Paris], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Descartes - Paris 5 (UPD5), Department of Medicine, Imperial College London, London, United Kingdom, University of California, Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Scripps Research Institute, Imperial College Healthcare NHS Trust- BRC Funding, American Foundation for AIDS Research, Medical Research Council (MRC), MRC DCS, British HIV Association (BHIVA), and Larose, Catherine

Subjects
CD4(+) T-CELLS, 0301 basic medicine, International Cooperation, [SDV]Life Sciences [q-bio], VIRAL RESERVOIR, Human immunodeficiency virus (HIV), Stakeholder engagement, HIV Infections, [SDV.GEN] Life Sciences [q-bio]/Genetics, Research & Experimental Medicine, medicine.disease_cause, Medicine, Societies, Medical, IN-VIVO, ComputingMilieux_MISCELLANEOUS, HIGHLY PATHOGENIC SIV, virus diseases, LATENT HIV-1, 11 Medical And Health Sciences, General Medicine, TREATMENT INTERRUPTION, 3. Good health, [SDV] Life Sciences [q-bio], International AIDS Society Towards a Cure Working Group, Medicine, Research & Experimental, Goals, Life Sciences & Biomedicine, BROADLY NEUTRALIZING ANTIBODIES, Biochemistry & Molecular Biology, medicine.medical_specialty, RALTEGRAVIR INTENSIFICATION, Immunology, education, Article, General Biochemistry, Genetics and Molecular Biology, HISTONE DEACETYLASE INHIBITOR, 03 medical and health sciences, Global population, Acquired immunodeficiency syndrome (AIDS), SUPPRESSIVE ANTIRETROVIRAL THERAPY, Journal Article, Humans, Organizational Objectives, Acquired Immunodeficiency Syndrome, [SDV.GEN]Life Sciences [q-bio]/Genetics, Science & Technology, business.industry, Research, Cell Biology, medicine.disease, Antiretroviral therapy, 030104 developmental biology, Treatment interruption, Family medicine, business
Abstract

Antiretroviral therapy is not curative. Given the challenges in providing lifelong therapy to a global population of more than 35 million people living with HIV, there is intense interest in developing a cure for HIV infection. The International AIDS Society convened a group of international experts to develop a scientific strategy for research towards an HIV cure. This Perspective summarizes the group's strategy.

Published
2016
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27. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

Author

Aringer, M. Costenbader, K. Daikh, D. Brinks, R. Mosca, M. Ramsey-Goldman, R. Smolen, J.S. Wofsy, D. Boumpas, D.T. Kamen, D.L. Jayne, D. Cervera, R. Costedoat-Chalumeau, N. Diamond, B. Gladman, D.D. Hahn, B. Hiepe, F. Jacobsen, Sø. Khanna, D. Lerstrøm, K. Massarotti, E. McCune, J. Ruiz-Irastorza, G. Sanchez-Guerrero, J. Schneider, M. Urowitz, M. Bertsias, G. Hoyer, B.F. Leuchten, N. Tani, C. Tedeschi, S.K. Touma, Z. Schmajuk, G. Anic, B. Assan, F. Chan, T.M. Clarke, A.E. Crow, M.K. Czirják, L. Doria, A. Graninger, W. Halda-Kiss, B. Hasni, S. Izmirly, P.M. Jung, M. Kumánovics, G. Mariette, X. Padjen, I. Pego-Reigosa, J.M. Romero-Diaz, J. Rúa-Figueroa Fernández, Í. Seror, R. Stummvoll, G.H. Tanaka, Y. Tektonidou, M.G. Vasconcelos, C. Vital, E.M. Wallace, D.J. Yavuz, S. Meroni, P.L. Fritzler, M.J. Naden, R. Dörner, T. Johnson, S.R.

Subjects
immune system diseases, skin and connective tissue diseases
Abstract

Objective To develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods This international initiative had four phases. (1) Evaluation of antinuclear antibody (ANA) as an entry criterion through systematic review and meta-regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort and a patient survey. (2) Criteria reduction by Delphi and nominal group technique exercises. (3) Criteria definition and weighting based on criterion performance and on results of a multi-criteria decision analysis. (4) Refinement of weights and threshold scores in a new derivation cohort of 1001 subjects and validation compared with previous criteria in a new validation cohort of 1270 subjects. Results The 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in seven clinical (constitutional, haematological, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and three immunological (antiphospholipid antibodies, complement proteins, SLE-specific antibodies) domains, and weighted from 2 to 10. Patients accumulating ≥10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared with 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics 2012 criteria. Conclusion These new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered and weighted criteria reflect current thinking about SLE and provide an improved foundation for SLE research. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Published
2019

38. Regorafenib Dose Optimization Study (ReDOS): Randomized phase II trial to evaluate escalating dosing strategy and pre-emptive topical steroids for regorafenib in refractory metastatic colorectal cancer (mCRC) – An ACCRU Network study

Author

Bekaii-Saab, T., primary, Ou, F., additional, Anderson, D., additional, Ahn, D., additional, Boland, P., additional, Ciombor, K., additional, Jacobs, N., additional, Desnoyers, R., additional, Cleary, J., additional, Meyers, J., additional, Chiorean, E., additional, Pedersen, K., additional, Barzi, A., additional, Sloan, J., additional, McCune, J., additional, Lacouture, M., additional, Lenz, H., additional, and Grothey, A., additional

Published
2018
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39. The Scid-hu Mouse: Current Status and Potential Applications

Author

McCune, J. M., Kaneshima, H., Lieberman, M., Weissman, I. L., Namikawa, R., Compans, R. W., editor, Cooper, M., editor, Koprowski, H., editor, McConnell, I., editor, Melchers, F., editor, Nussenzweig, V., editor, Oldstone, M., editor, Olsnes, S., editor, Saedler, H., editor, Vogt, P. K., editor, Wagner, H., editor, Wilson, I., editor, Bosma, Melvin J., editor, Phillips, Robert A., editor, and Schuler, Walter, editor

Published
1989
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40. The SCID-hu Mouse: A Small Animal Model for HIV Infection and Antiviral Testing

Author

McCune, J. M., Namikawa, R., Shih, C.-C., Rabin, L., Kaneshima, H., Melchers, Fritz, editor, Albert, E. D., editor, von Boehmer, H., editor, Dierich, M. P., editor, Du Pasquier, L., editor, Eichmann, K., editor, Gemsa, D., editor, Götze, O., editor, Kalden, J. R., editor, Kaufmann, S. H. E., editor, Kirchner, H., editor, Resch, K., editor, Riethmüller, G., editor, Schimpl, A., editor, Sorg, C., editor, Steinmetz, M., editor, Wagner, H., editor, and Zachau, H. G., editor

Published
1989
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42. Design of the Wegener's Granulomatosis Etanercept Trial (WGET)

Author

Stone, J, Uhlfelder, M, Moore, A, Hoffman, G, Holbrook, J, Meinert, C, Donithan, J, Min, N, Murrow, L, Oziemkowska, M, Tibbs, A, Tonascia, J, Van Natta, M, McCune, J, Coomer, B, Gilson, B, Haftel, H, Martinez, F, Rose, N, Burek, C, Barin, J, Talor, M, Canner, P, Conn, D, and Klippel, J

Published
2016

43. Why Has Model‐Informed Precision Dosing Not Yet Become Common Clinical Reality? Lessons From the Past and a Roadmap for the Future

Author

Darwich, A S, primary, Ogungbenro, K, additional, Vinks, A A, additional, Powell, J R, additional, Reny, J‐L, additional, Marsousi, N, additional, Daali, Y, additional, Fairman, D, additional, Cook, J, additional, Lesko, L J, additional, McCune, J S, additional, Knibbe, C A J, additional, de Wildt, S N, additional, Leeder, J S, additional, Neely, M, additional, Zuppa, A F, additional, Vicini, P, additional, Aarons, L, additional, Johnson, T N, additional, Boiani, J, additional, and Rostami‐Hodjegan, A, additional

Published
2017
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45. O-014 - Regorafenib Dose Optimization Study (ReDOS): Randomized phase II trial to evaluate escalating dosing strategy and pre-emptive topical steroids for regorafenib in refractory metastatic colorectal cancer (mCRC) – An ACCRU Network study

Author

Bekaii-Saab, T., Ou, F., Anderson, D., Ahn, D., Boland, P., Ciombor, K., Jacobs, N., Desnoyers, R., Cleary, J., Meyers, J., Chiorean, E., Pedersen, K., Barzi, A., Sloan, J., McCune, J., Lacouture, M., Lenz, H., and Grothey, A.

Published
2018
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46. Population Pharmacokinetics and Dose Optimization of Mycophenolic Acid in HCT Recipients Receiving Oral Mycophenolate Mofetil

Author

Li, H, Mager, D E, Sandmaier, B M, Maloney, D G, Bemer, M J, and McCune, J S

Subjects
Adult, Male, Antibiotics, Antineoplastic, Adolescent, Hematopoietic Stem Cell Transplantation, Administration, Oral, Infant, Middle Aged, Mycophenolic Acid, Models, Biological, Article, stomatognathic diseases, Young Adult, Child, Preschool, Cyclosporine, Humans, Transplantation, Homologous, Female, Child, Immunosuppressive Agents, Serum Albumin, Aged
Abstract

We sought to create a population pharmacokinetic model for total mycophenolic acid (MPA), to study the effects of different covariates on MPA pharmacokinetics, to create a limited sampling schedule (LSS) to characterize MPA exposure (i.e., area under the curve or AUC) with maximum a posteriori Bayesian estimation, and to simulate an optimized dosing scheme for allogeneic hematopoietic cell transplantation (HCT) recipients. Four thousand four hundred ninety-six MPA concentration-time points from 408 HCT recipients were analyzed retrospectively using a nonlinear mixed effects modeling approach. MPA pharmacokinetics was characterized with a two-compartment model with first-order elimination and a time-lagged first-order absorption process. Concomitant cyclosporine and serum albumin were significant covariates. The median MPA clearance (CL) and volume of the central compartment were 24.2 L/hour and 36.4 L, respectively, for a 70 kg patient receiving tacrolimus with a serum albumin of 3.4 g/dL. Dosing simulations indicated that higher oral MMF doses are needed with concomitant cyclosporine, which increases MPA CL by 33.8%. The optimal LSS was immediately before and at 0.25 hours, 1.25 hours, 2 hours, and 4 hours after oral mycophenolate mofetil administration. MPA AUC in an individual HCT recipient can be accurately estimated using a five-sample LSS and maximum a posteriori Bayesian estimation.

Published
2013

47. Clonal analysis of the peripheral T cell compartment of the SCID-hu mouse

Author

Vandekerckhove, B. A., Krowka, J. F., McCune, J. M., de Vries, J. E., Spits, H., Roncarolo, M. G., and Other departments

Subjects
Immunology, Immunology and Allergy
Abstract

Severe combined immunodeficiency (SCID) mice can be transplanted successfully with human fetal liver and thymus (SCID-hu mice). Precursor cells derived from the fetal liver differentiate in the thymus and migrate into the blood as mature T cells. In the present paper, the peripheral T cell compartment of such mice was studied. Peripheral WBC were activated by PHA and cultured in the presence of irradiated human feeder cells. The resultant cell population consisted exclusively of human CD1- CD2+ CD3+ CD7+ T lymphocytes; up to 4% of the T cells expressed the TCR gamma delta, whereas 95 to 100% were TCR alpha beta +. The CD4bright (42 to 66%) and CD8bright (30 to 54%) populations coexpressed variable but low levels of CD8 and CD4, respectively. The T cell cultures from the SCID-hu mice did not display reactivity towards the autologous human EBV-transformed B cell lines (B-LCL). On the other hand, these human T cells proliferated and were cytotoxic against allogeneic human B-LCL. T cell clones were established from cultured SCID-hu T cells. All T cell clones were TCR alpha beta + CD3+ CD2+; 61% of the clones were CD4+ CD8-, 27% were CD8+ CD4-, 11% were CD8+ CD4lo, and 2% were CD4+ CD8lo. None of these clones recognized the autologous B-LCL established from the fetal human donor. Fourteen of 100 T cell clones had specific alloreactivity, as tested on a panel of five B-LCL. Of these 14, two CD8+ CD4lo and two CD8+ CD4- clones were cytotoxic and did not proliferate in response to specific stimulator cells. Furthermore, two CD4+ CD8lo and eight CD4+ CD8- clones proliferated specifically in response to alloantigens. In conclusion, the peripheral human T cells of SCID-hu animals are functional and their TCR repertoire is polyclonal, alloreactive, and devoid of self-reactive cells. Therefore, the SCID-hu mouse can be a suitable model for the study of alloreactivity and allotolerance in vivo, as well as for the study of negative selection in the human thymus.

Published
1991
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49. The Kynurenine Pathway of Tryptophan Catabolism, CD4+ T-Cell Recovery, and Mortality Among HIV-Infected Ugandans Initiating Antiretroviral Therapy

Author

Byakwaga, H., primary, Boum, Y., additional, Huang, Y., additional, Muzoora, C., additional, Kembabazi, A., additional, Weiser, S. D., additional, Bennett, J., additional, Cao, H., additional, Haberer, J. E., additional, Deeks, S. G., additional, Bangsberg, D. R., additional, McCune, J. M., additional, Martin, J. N., additional, and Hunt, P. W., additional

Published
2014
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50. Design of the Wegener's Granulomatosis Etanercept Trial (WGET)

Author

Stone, JH, Uhlfelder, ML, Moore, AM, Hoffman, GS, Holbrook, JT, Meinert, CL, Donithan, J, Min, N, Murrow, L, Oziemkowska, M, Tibbs, AK, Tonascia, J, Van Natta, M, McCune, J, Coomer, BJ, Gilson, B, Haftel, H, Martinez, F, Rose, NR, Burek, CL, Barin, J, Talor, M, Canner, PL, Conn, DL, Klippel, JH, Landis, JR, White, B, Luqmani, R, and Grp, WGETR

Published
2002

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