Surrogacy in HIV-1 clinical trials.

作者: Anton Pozniak

DOI: 10.1016/S0140-6736(98)22008-3

关键词: Human immunodeficiency virus (HIV)Clinical trialIntensive care medicineMedicine

摘要:

参考文章(12)
D. Mildvan, A. Landay, V. De Gruttola, S. G. Machado, J. Kagan, An Approach to the Validation of Markers for Use in AIDS Clinical Trials Clinical Infectious Diseases. ,vol. 24, pp. 764- 774 ,(1997) , 10.1093/CLINIDS/24.5.764
Debra S. Echt, Philip R. Liebson, L. Brent Mitchell, Robert W. Peters, Dulce Obias-Manno, Allan H. Barker, Daniel Arensberg, Andrea Baker, Lawrence Friedman, H. Leon Greene, Melissa L. Huther, David W. Richardson, Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo New England Journal of Medicine. ,vol. 324, pp. 781- 788 ,(1991) , 10.1056/NEJM199103213241201
J. W. Mellors, C. R. Rinaldo, P. Gupta, R. M. White, J. A. Todd, L. A. Kingsley, Prognosis in HIV-1 Infection Predicted by the Quantity of Virus in Plasma Science. ,vol. 272, pp. 1167- 1170 ,(1996) , 10.1126/SCIENCE.272.5265.1167
V. De Gruttola, T. Fleming, D. Y. Lin, R. Coombs, Perspective: Validating Surrogate Markers—Are We Being Naive? The Journal of Infectious Diseases. ,vol. 175, pp. 237- 246 ,(1997) , 10.1093/INFDIS/175.2.237
Sabine Yerly, Thomas V Perneger, Bernard Hirschel, Olivier Dubuis, Lukas Matter, Raffaele Malinverni, Hansjakob Furrer, Luc Perrin, Swiss HIV Cohort Study, A Critical Assessment of the Prognostic Value of HIV-1 RNA Levels and CD4 + Cell Counts in HIV-Infected Patients JAMA Internal Medicine. ,vol. 158, pp. 247- 252 ,(1998) , 10.1001/ARCHINTE.158.3.247
Thomas R. Fleming, Surrogate End Points in Clinical Trials: Are We Being Misled? Annals of Internal Medicine. ,vol. 125, pp. 605- 613 ,(1996) , 10.7326/0003-4819-125-7-199610010-00011
Thomas R O'Brien, William A Blattner, David Waters, M Elaine Eyster, Margaret W Hilgartner, Alan R Cohen, Naomi Luban, Angelos Hatzakis, Louis M Aledort, Philip S Rosenberg, Wendell J Miley, Barbara L Kroner, James J Goedert, Serum HIV-1 RNA Levels and Time to Development of AIDS in the Multicenter Hemophilia Cohort Study JAMA: The Journal of the American Medical Association. ,vol. 276, pp. 105- 110 ,(1996) , 10.1001/JAMA.1996.03540020027025
Roy M. Gulick, John W. Mellors, Diane Havlir, Joseph J. Eron, Charles Gonzalez, Deborah McMahon, Douglas D. Richman, Fred T. Valentine, Leslie Jonas, Anne Meibohm, Emilio A. Emini, Jeffrey A. Chodakewitz, Paul Deutsch, Daniel Holder, William A. Schleif, Jon H. Condra, Treatment with Indinavir, Zidovudine, and Lamivudine in Adults with Human Immunodeficiency Virus Infection and Prior Antiretroviral Therapy The New England Journal of Medicine. ,vol. 337, pp. 734- 739 ,(1997) , 10.1056/NEJM199709113371102
David A. Katzenstein, Scott M. Hammer, Michael D. Hughes, Holly Gundacker, J. Brooks Jackson, Susan Fiscus, Suraiya Rasheed, Tarek Elbeik, Richard Reichman, Anthony Japour, Thomas C. Merigan, Martin S. Hirsch, The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter The New England Journal of Medicine. ,vol. 335, pp. 1091- 1098 ,(1996) , 10.1056/NEJM199610103351502