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Volumn 17, Issue 21, 1998, Pages 2435-2462

NIAID Workshop, Memphis, Tennessee, 25-26 March 1997: Statistical issues for HIV surrogate endpoints: Point/counterpoint

(21)  Albert, Jeffrey M a,n   Ioannidis, John P A a   Reichelderfer, Patricia a   Conway, Brian b   Coombs, Robert W c   Crane, Lawrence d   Demasi, Ralph e   Dixon, Dennis O a   Flandre, Phillipe f   Hughes, Michael D g   Kalish, Leslie A h   Larntz, Kinley i   Lin, Danyu c   Marschner, Ian C j   Muñoz, Alvaro k   Murray, Jeff l   Neaton, Jim i   Pettinelli, Carla a   Rida, Wasima a   Taylor, Jeremy M G m   more..


Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; CD4 ANTIGEN; VIRUS RNA; BIOLOGICAL MARKER;

EID: 0032533023     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19981115)17:21<2435::AID-SIM994>3.0.CO;2-G     Document Type: Conference Paper
Times cited : (40)

References (71)
  • 2
    • 0025091878 scopus 로고
    • Sources of variability in repeated T-helper lymphocyte counts from human immunodeficiency virus type 1-infected patients: Total lymphocyte count fluctuations and diurnal cycle are important
    • Malone, J. L., Simms, T. E., Gray, C. G., Wagner, R. F., Burge, J. R. and Burke, D. S. 'Sources of variability in repeated T-helper lymphocyte counts from human immunodeficiency virus type 1-infected patients: Total lymphocyte count fluctuations and diurnal cycle are important', Journal of Acquired Immune Deficiency Syndromes, 3, 144-151 (1990).
    • (1990) Journal of Acquired Immune Deficiency Syndromes , vol.3 , pp. 144-151
    • Malone, J.L.1    Simms, T.E.2    Gray, C.G.3    Wagner, R.F.4    Burge, J.R.5    Burke, D.S.6
  • 3
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: Definitions and operational criteria
    • Prentice, R. L. 'Surrogate endpoints in clinical trials: definitions and operational criteria', Statistics in Medicine, 8, 431-440 (1989).
    • (1989) Statistics in Medicine , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 6
    • 0031441790 scopus 로고    scopus 로고
    • The relationship between study design, results and reporting in randomized trials of HIV infection
    • Ioannidis, J. P. A., Cappelleri, J. C., Sacks, H. S. and Lau, J. 'The relationship between study design, results and reporting in randomized trials of HIV infection', Controlled Clinical Trials, 18, 431-444 (1997).
    • (1997) Controlled Clinical Trials , vol.18 , pp. 431-444
    • Ioannidis, J.P.A.1    Cappelleri, J.C.2    Sacks, H.S.3    Lau, J.4
  • 8
    • 0027403928 scopus 로고
    • CD4 + lymphocytes are an incomplete surrogate marker for clinical disease progression in persons with asymptomatic HIV infection
    • Choi, S., Lagakos, S. W., Schooley, R. T., and Volberding, P. A. 'CD4 + lymphocytes are an incomplete surrogate marker for clinical disease progression in persons with asymptomatic HIV infection', Annals of Internal Medicine, 118, 674-680 (1993).
    • (1993) Annals of Internal Medicine , vol.118 , pp. 674-680
    • Choi, S.1    Lagakos, S.W.2    Schooley, R.T.3    Volberding, P.A.4
  • 9
    • 0344172588 scopus 로고    scopus 로고
    • Can HIV-1 RNA viral load be used as a surrogate for clinical outcome in HIV disease?
    • Hamburg, Germany, 11-15 October Abstract 103
    • Babiker, A. for the Delta Co-ordinating Committee and Virological Group. 'Can HIV-1 RNA viral load be used as a surrogate for clinical outcome in HIV disease?', 6th European conference on Clinical Aspects and Treatment of HIV Infection, Hamburg, Germany, 11-15 October 1997 (Abstract 103).
    • (1997) 6th European Conference on Clinical Aspects and Treatment of HIV Infection
    • Babiker, A.1
  • 11
    • 0030070991 scopus 로고    scopus 로고
    • Prognosis of HIV-1 infection predicted by the quantity of virus in plasma
    • Mellors, J. W., Rinaldo, C. R., Gupta, P., White, R. M., Todd, J. A. and Kingsley, L. A. 'Prognosis of HIV-1 infection predicted by the quantity of virus in plasma', Science, 272, 1167-1170 (1996).
    • (1996) Science , vol.272 , pp. 1167-1170
    • Mellors, J.W.1    Rinaldo, C.R.2    Gupta, P.3    White, R.M.4    Todd, J.A.5    Kingsley, L.A.6
  • 14
    • 3643137214 scopus 로고    scopus 로고
    • Empirical power for tests on longitudinal data with non-informative missingness with applications to AIDS trials
    • Memphis, TN, March
    • Kuhn, A. M. and DeMasi, R. A. 'Empirical power for tests on longitudinal data with non-informative missingness with applications to AIDS trials', Presentation at the International Biometric Society Eastern North American Region Meetings, Memphis, TN, March, 1997.
    • (1997) International Biometric Society Eastern North American Region Meetings
    • Kuhn, A.M.1    DeMasi, R.A.2
  • 15
    • 0030055871 scopus 로고    scopus 로고
    • Variation in plasma RNA levels, CD4 cell counts, and p24 antigen levels in clinically stable men with human immunodeficiency virus infection
    • Raboud, J. M., Montaner, J. S., Conway, B., Maley, L., Sherlock, C., O'Shaughnessy, M. V. and Schlechter, M. T. 'Variation in plasma RNA levels, CD4 cell counts, and p24 antigen levels in clinically stable men with human immunodeficiency virus infection', Journal of Infectious Diseases, 174, 191-194 (1996).
    • (1996) Journal of Infectious Diseases , vol.174 , pp. 191-194
    • Raboud, J.M.1    Montaner, J.S.2    Conway, B.3    Maley, L.4    Sherlock, C.5    O'Shaughnessy, M.V.6    Schlechter, M.T.7
  • 16
    • 0029940354 scopus 로고    scopus 로고
    • Viral counts count in HIV infection
    • Ho, D. D. 'Viral counts count in HIV infection', Science, 272, 1124-1125 (1996).
    • (1996) Science , vol.272 , pp. 1124-1125
    • Ho, D.D.1
  • 18
    • 0028874048 scopus 로고
    • Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infections
    • Ho, D. D., Neumann, A. U., Perelson, A. S., Chen, W., Leonard, J. M. and Markowitz, M. 'Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infections', Nature, 373, 123-126 (1995).
    • (1995) Nature , vol.373 , pp. 123-126
    • Ho, D.D.1    Neumann, A.U.2    Perelson, A.S.3    Chen, W.4    Leonard, J.M.5    Markowitz, M.6
  • 21
    • 0031026507 scopus 로고    scopus 로고
    • Longitudinal analysis of quantitative virologic measures in HIV infected subjects with <400 CD4 lymphocytes: Implications for applying measurements to individual patients
    • Paxton, W. B., Coombs, R. W., McElrath, M. J., Keefer, M. C., Hughes J., Sinangil, F., Chernoff, D., Demeter, L., Williams, B. and Corey, L. 'Longitudinal analysis of quantitative virologic measures in HIV infected subjects with <400 CD4 lymphocytes: implications for applying measurements to individual patients', Journal of Infectious Diseases, 175, 247-254 (1997).
    • (1997) Journal of Infectious Diseases , vol.175 , pp. 247-254
    • Paxton, W.B.1    Coombs, R.W.2    McElrath, M.J.3    Keefer, M.C.4    Hughes, J.5    Sinangil, F.6    Chernoff, D.7    Demeter, L.8    Williams, B.9    Corey, L.10
  • 23
    • 0027304957 scopus 로고
    • Elevated levels of CD38 + CD8+ T cells in HIV infection add to the prognostic value of low CD4+ T cell levels: Results of 6 years of follow-up
    • Giorgi, J. V., Liu, Z., Hultin, L.E., Cumberland, W. G., Hennessey, K. and Detels, R. 'Elevated levels of CD38 + CD8+ T cells in HIV infection add to the prognostic value of low CD4+ T cell levels: Results of 6 years of follow-up', Journal of Acquired Immune Deficiency Syndrome, 6, 904-912 (1993).
    • (1993) Journal of Acquired Immune Deficiency Syndrome , vol.6 , pp. 904-912
    • Giorgi, J.V.1    Liu, Z.2    Hultin, L.E.3    Cumberland, W.G.4    Hennessey, K.5    Detels, R.6
  • 27
    • 0029978714 scopus 로고    scopus 로고
    • Predictive value of viral load measurements in asymptomatic, untreated HIV-infection: A mathematical model
    • Ioannidis, J. P. A., Cappelleri, J. C., Lau, J., Sacks, H. S. and Skolnik, P. R. 'Predictive value of viral load measurements in asymptomatic, untreated HIV-infection: a mathematical model', AIDS, 10, 255-262 (1996).
    • (1996) AIDS , vol.10 , pp. 255-262
    • Ioannidis, J.P.A.1    Cappelleri, J.C.2    Lau, J.3    Sacks, H.S.4    Skolnik, P.R.5
  • 28
    • 0029809569 scopus 로고    scopus 로고
    • Impact of epidemic and individual heterogeneity on the population distibution of disease progression rates. An example from patient populations in trials of human immunodeficiency virus infection
    • Ioannidis, J. P. A., Cappelleri, J. C., Schmid, C. H. and Lau, J. 'Impact of epidemic and individual heterogeneity on the population distibution of disease progression rates. An example from patient populations in trials of human immunodeficiency virus infection', American Journal of Epidemiology, 144, 1074-1085 (1996).
    • (1996) American Journal of Epidemiology , vol.144 , pp. 1074-1085
    • Ioannidis, J.P.A.1    Cappelleri, J.C.2    Schmid, C.H.3    Lau, J.4
  • 29
    • 0010707276 scopus 로고    scopus 로고
    • Clinical efficacy of antiretroviral changes in treatment-experienced HIV-infected patients. a meta-analysis
    • 15 May 1997; Doc No 204
    • Ioannidis, J. P. A., Sacks, H. S., Cappelleri, J. C. and Lau, J. 'Clinical efficacy of antiretroviral changes in treatment-experienced HIV-infected patients. A meta-analysis', Online Journal of Current Clinical Trials, 15 May 1997; Doc No 204 (1997).
    • (1997) Online Journal of Current Clinical Trials
    • Ioannidis, J.P.A.1    Sacks, H.S.2    Cappelleri, J.C.3    Lau, J.4
  • 30
    • 0030317890 scopus 로고    scopus 로고
    • Viral dynamics of human immunodeficiency virus: Implications for drug development and therapeutic strategies
    • Havlir, D. V. and Richman, D. D. 'Viral dynamics of human immunodeficiency virus: implications for drug development and therapeutic strategies', Annals of Internal Medicine, 124, 984-994 (1996).
    • (1996) Annals of Internal Medicine , vol.124 , pp. 984-994
    • Havlir, D.V.1    Richman, D.D.2
  • 33
    • 0029445090 scopus 로고
    • Resistance to anti-human immunodeficiency virus therapeutic agents
    • Emini, E. A. 'Resistance to anti-human immunodeficiency virus therapeutic agents', Advances in Experimental Medicine and Biology, 390, 187-195 (1995).
    • (1995) Advances in Experimental Medicine and Biology , vol.390 , pp. 187-195
    • Emini, E.A.1
  • 34
    • 0001198982 scopus 로고
    • The consequences of adjustment for a concomitant variable that has been affected by the treatment
    • Rosenbaum, P. R. 'The consequences of adjustment for a concomitant variable that has been affected by the treatment', Journal of the Royal Statistical Society, Series A, 147, 656-666 (1984).
    • (1984) Journal of the Royal Statistical Society, Series A , vol.147 , pp. 656-666
    • Rosenbaum, P.R.1
  • 35
    • 0028101413 scopus 로고
    • Surrogate markers in AIDS and cancer trials
    • Fleming, T. R. 'Surrogate markers in AIDS and cancer trials', Statistics in Medicine, 13, 1423-1435 (1994).
    • (1994) Statistics in Medicine , vol.13 , pp. 1423-1435
    • Fleming, T.R.1
  • 36
    • 0030777744 scopus 로고    scopus 로고
    • Meta-analysis for the evaluation of potential surrogate markers
    • Daniels, M. J. and Hughes, M. D. 'Meta-analysis for the evaluation of potential surrogate markers', Statistics in Medicine, 16, 1965-1982 (1997).
    • (1997) Statistics in Medicine , vol.16 , pp. 1965-1982
    • Daniels, M.J.1    Hughes, M.D.2
  • 38
    • 0030915453 scopus 로고    scopus 로고
    • Estimating the proportion of treatment effect explained by a surrogate marker
    • Lin, D. Y., Fleming, T. R. and DeGruttola, V. 'Estimating the proportion of treatment effect explained by a surrogate marker', Statistics in Medicine, 16, 901-910 (1997).
    • (1997) Statistics in Medicine , vol.16 , pp. 901-910
    • Lin, D.Y.1    Fleming, T.R.2    DeGruttola, V.3
  • 40
    • 0027160462 scopus 로고
    • Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials
    • Lin, D. Y., Fischl, M. A. and Schoenfeld, D. A. 'Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials', Statistics in Medicine, 12, 835-842 (1993).
    • (1993) Statistics in Medicine , vol.12 , pp. 835-842
    • Lin, D.Y.1    Fischl, M.A.2    Schoenfeld, D.A.3
  • 45
    • 0030460411 scopus 로고    scopus 로고
    • Comparison of semiparametric and parametric survival models for the analysis of bronchial responsiveness
    • Muñoz, A. and Sunyer, J. 'Comparison of semiparametric and parametric survival models for the analysis of bronchial responsiveness', American Journal of Respiratory and Critical Care Medicine, 154, S234-S239 (1996).
    • (1996) American Journal of Respiratory and Critical Care Medicine , vol.154
    • Muñoz, A.1    Sunyer, J.2
  • 47
    • 0025073486 scopus 로고
    • Selection of patients for randomized controlled trials: Implications of wide or narrow eligibility criteria
    • Yusuf, S., Held, P., Teo, K. K. and Toretsky, E. R. 'Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria', Statistics in Medicine, 9, 73-86 (1990).
    • (1990) Statistics in Medicine , vol.9 , pp. 73-86
    • Yusuf, S.1    Held, P.2    Teo, K.K.3    Toretsky, E.R.4
  • 48
    • 0029783604 scopus 로고    scopus 로고
    • CD4+ T lymphocyte counts and patterns of mortality among patients infected with human immunodeficiency virus who were enrolled in Community Programs for Clinical Research on AIDS
    • Saravolatz, L., Neaton, J. D., Sacks, L., Deyton, L., Rhame, F. and Sherer, R. 'CD4+ T lymphocyte counts and patterns of mortality among patients infected with human immunodeficiency virus who were enrolled in Community Programs for Clinical Research on AIDS', Clinical Infectious Diseases, 22, 513-520 (1996).
    • (1996) Clinical Infectious Diseases , vol.22 , pp. 513-520
    • Saravolatz, L.1    Neaton, J.D.2    Sacks, L.3    Deyton, L.4    Rhame, F.5    Sherer, R.6
  • 50
    • 0029792776 scopus 로고    scopus 로고
    • HIV reverse transcriptase codon 215 mutations diminish virologic response to didanosine-zidovudine treatment in subjects with non-syncytium inducing phenotype
    • Holodnyi, M., Katzenstein, D., Mole, L., Winters, M. and Merigan, T. 'HIV reverse transcriptase codon 215 mutations diminish virologic response to didanosine-zidovudine treatment in subjects with non-syncytium inducing phenotype', Journal of Infectious Diseases, 174, 854-857 (1996).
    • (1996) Journal of Infectious Diseases , vol.174 , pp. 854-857
    • Holodnyi, M.1    Katzenstein, D.2    Mole, L.3    Winters, M.4    Merigan, T.5
  • 52
    • 0029789255 scopus 로고    scopus 로고
    • Factors affecting survival in patients with the acquired immune deficiency syndrome
    • Mocroft, A., Johnson, M. A. and Phillips, A. N. 'Factors affecting survival in patients with the acquired immune deficiency syndrome' [editorial], AIDS, 10, 1057-1065 (1996).
    • (1996) AIDS , vol.10 , pp. 1057-1065
    • Mocroft, A.1    Johnson, M.A.2    Phillips, A.N.3
  • 54
    • 0026573094 scopus 로고
    • Statistical validation of intermediate endpoints for chronic diseases
    • Freedman, L. S., Graubard, B. L. and Schatzkin, A. 'Statistical validation of intermediate endpoints for chronic diseases', Statistics in Medicine, 11, 167-178 (1993).
    • (1993) Statistics in Medicine , vol.11 , pp. 167-178
    • Freedman, L.S.1    Graubard, B.L.2    Schatzkin, A.3
  • 55
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate endpoints in clinical trials: Are we being misled?
    • Fleming, T. R. and DeMets, D. L. 'Surrogate endpoints in clinical trials: are we being misled?', Annals of Internal Medicine, 125, 605-613 (1996).
    • (1996) Annals of Internal Medicine , vol.125 , pp. 605-613
    • Fleming, T.R.1    DeMets, D.L.2
  • 56
    • 0024321898 scopus 로고
    • Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. 'Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction', New England Journal of Medicine, 321, 406-412 (1989).
    • (1989) New England Journal of Medicine , vol.321 , pp. 406-412
  • 58
    • 0027420145 scopus 로고
    • Modeling the relationship between survival and CD4 lymphocytes inpatients with AIDS and AIDS related complex
    • DeGrutolla, V., Wulfsohn, M., Fischl, M. A. and Tsiatis, A. 'Modeling the relationship between survival and CD4 lymphocytes inpatients with AIDS and AIDS related complex', Journal of Acquired Immune Deficiency Syndromes, 6, 359-365 (1993).
    • (1993) Journal of Acquired Immune Deficiency Syndromes , vol.6 , pp. 359-365
    • DeGrutolla, V.1    Wulfsohn, M.2    Fischl, M.A.3    Tsiatis, A.4
  • 59
    • 21844506206 scopus 로고
    • Modeling the relationship of survival to longitudinal data measured with error. Applications to survival and CD4 counts in patients with AIDS
    • Tsiatis, A. A., DeGruttola, V. and Wulfsohn, M. 'Modeling the relationship of survival to longitudinal data measured with error. Applications to survival and CD4 counts in patients with AIDS', Journal of the American Statistical Association, 90, 27-37 (1995).
    • (1995) Journal of the American Statistical Association , vol.90 , pp. 27-37
    • Tsiatis, A.A.1    DeGruttola, V.2    Wulfsohn, M.3
  • 63
    • 0026062027 scopus 로고
    • Changing disease patterns in patients with AIDS in a referral center in the United Kingdom: The changing face of AIDS
    • Peters, B. S., Coleman, D. G., McGuiness, O., Pinching, A. J., Wadsworth, M. J., and Harris, J. R. 'Changing disease patterns in patients with AIDS in a referral center in the United Kingdom: the changing face of AIDS', British Medical Journal, 302, 203-207 (1991).
    • (1991) British Medical Journal , vol.302 , pp. 203-207
    • Peters, B.S.1    Coleman, D.G.2    McGuiness, O.3    Pinching, A.J.4    Wadsworth, M.J.5    Harris, J.R.6
  • 69
    • 1842338931 scopus 로고    scopus 로고
    • Randomized double-blind one year study of the immunologic and virologic effects of nevirapine, didanosine and zidovudine combinations among antiretroviral naïve AIDS-free patients with CD4 200-600
    • Conway, B., Montaner, J. S. B., Cooper, D., Vella, S., Reiss, P., Lange, J., Harris, M., Wainberg, M., Kwok, S., Sninsky, J., Hall, D., Myers, M. and the INCAS study group. 'Randomized double-blind one year study of the immunologic and virologic effects of nevirapine, didanosine and zidovudine combinations among antiretroviral naïve AIDS-free patients with CD4 200-600', AIDS, 10, S15 (1996).
    • (1996) AIDS , vol.10
    • Conway, B.1    Montaner, J.S.B.2    Cooper, D.3    Vella, S.4    Reiss, P.5    Lange, J.6    Harris, M.7    Wainberg, M.8    Kwok, S.9    Sninsky, J.10    Hall, D.11    Myers, M.12


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