메뉴 건너뛰기




Volumn 12, Issue 14, 1998, Pages 1823-1832

CD4 cell count as a surrogate endpoint in HIV clinical trials: A meta-analysis of studies of the AIDS clinical trials group

Author keywords

CD4 cell count; Clinical trials; HIV infection; Surrogate endpoint

Indexed keywords

CD4 ANTIGEN; DIDANOSINE; NEVIRAPINE; SAQUINAVIR; ZALCITABINE; ZIDOVUDINE;

EID: 0032189130     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-199814000-00014     Document Type: Article
Times cited : (69)

References (42)
  • 1
    • 10144244674 scopus 로고    scopus 로고
    • A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200-500 per cubic millimeter
    • Hammer SM, Katzenstein DA, Hughes MD, et al.: A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200-500 per cubic millimeter. N Engl J Med 1996, 335:1081-1090.
    • (1996) N Engl J Med , vol.335 , pp. 1081-1090
    • Hammer, S.M.1    Katzenstein, D.A.2    Hughes, M.D.3
  • 2
    • 0030567824 scopus 로고    scopus 로고
    • DELTA: A randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine or zidovudine alone in HIV infected individuals
    • DELTA Coordinating Committee: DELTA: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine or zidovudine alone in HIV infected individuals. Lancet 1996, 343:283-291.
    • (1996) Lancet , vol.343 , pp. 283-291
  • 3
    • 0030997937 scopus 로고    scopus 로고
    • Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: The CAESAR trial
    • CAESAR Coordinating Committee: Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial. Lancet 1997, 349:1413-1421.
    • (1997) Lancet , vol.349 , pp. 1413-1421
  • 4
    • 0442268112 scopus 로고    scopus 로고
    • A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less
    • Hammer SM, Squires KE, Hughes MD, et al.: A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. N Engl J Med 1997, 337:725-733.
    • (1997) N Engl J Med , vol.337 , pp. 725-733
    • Hammer, S.M.1    Squires, K.E.2    Hughes, M.D.3
  • 5
    • 0025015623 scopus 로고
    • On the use of laboratory markers as surrogates for clinical endpoints in the evaluation of treatment for HIV infection
    • Machado SG, Gail MH, Ellenberg SS: On the use of laboratory markers as surrogates for clinical endpoints in the evaluation of treatment for HIV infection. J Acquir Immune Defic Syndr 1990, 3:1065-1073.
    • (1990) J Acquir Immune Defic Syndr , vol.3 , pp. 1065-1073
    • Machado, S.G.1    Gail, M.H.2    Ellenberg, S.S.3
  • 6
    • 0026591512 scopus 로고
    • Surrogate markers in AIDS: Where are we? Where are we going?
    • Lagakos SW, Hoth DF: Surrogate markers in AIDS: Where are we? Where are we going? Ann Intern Med 1992, 116:599-601.
    • (1992) Ann Intern Med , vol.116 , pp. 599-601
    • Lagakos, S.W.1    Hoth, D.F.2
  • 9
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate end points in clinical trials: Are we being misled?
    • Fleming T, DeMets D: Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996, 125:605-613.
    • (1996) Ann Intern Med , vol.125 , pp. 605-613
    • Fleming, T.1    DeMets, D.2
  • 10
    • 1842296349 scopus 로고    scopus 로고
    • Plasma viral load and CD4+ lymphocytes as prognostic markers in HIV-1 infection
    • Mellors JW, Munoz A, Giorgi JV, et al.: Plasma viral load and CD4+ lymphocytes as prognostic markers in HIV-1 infection. Ann Intern Med 1997, 126:946-954.
    • (1997) Ann Intern Med , vol.126 , pp. 946-954
    • Mellors, J.W.1    Munoz, A.2    Giorgi, J.V.3
  • 11
    • 0031570404 scopus 로고    scopus 로고
    • Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response
    • Hughes MD, Johnson VA, Hirsch MS, et al.: Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. Ann Intern Med 1997, 126:929-938.
    • (1997) Ann Intern Med , vol.126 , pp. 929-938
    • Hughes, M.D.1    Johnson, V.A.2    Hirsch, M.S.3
  • 12
    • 0031006111 scopus 로고    scopus 로고
    • Changes in plasma HIV-1 RNA levels and CD4+ lymphocyte counts predict both response to antiretroviral therapy and therapeutic failure
    • O'Brien WA, Hartigan PM, Daar ES, Simberkoff MS, Hamilton JD, for the VA Cooperative Study Group on AIDS: Changes in plasma HIV-1 RNA levels and CD4+ lymphocyte counts predict both response to antiretroviral therapy and therapeutic failure. Ann Intern Med 1997, 126:939-945.
    • (1997) Ann Intern Med , vol.126 , pp. 939-945
    • O'Brien, W.A.1    Hartigan, P.M.2    Daar, E.S.3    Simberkoff, M.S.4    Hamilton, J.D.5
  • 13
    • 0027403928 scopus 로고
    • CD4 + lymphocytes are an incomplete surrogate marker for clinical progression in persons with asymptomatic HIV infection taking zidovudine
    • Choi S, Lagakos SW, Schooley TT, Volberding PA: CD4 + lymphocytes are an incomplete surrogate marker for clinical progression in persons with asymptomatic HIV infection taking zidovudine. Ann Intern Med 1993, 118:674-680.
    • (1993) Ann Intern Med , vol.118 , pp. 674-680
    • Choi, S.1    Lagakos, S.W.2    Schooley, T.T.3    Volberding, P.A.4
  • 14
    • 0027420145 scopus 로고
    • Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex
    • De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A: Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr 1993, 6:359-365.
    • (1993) J Acquir Immune Defic Syndr , vol.6 , pp. 359-365
    • De Gruttola, V.1    Wulfsohn, M.2    Fischl, M.A.3    Tsiatis, A.4
  • 15
    • 0027160462 scopus 로고
    • Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials
    • Lin DY, Fischl MA, Schoenfeld DA: Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials. Stat Med 1993, 12:835-842.
    • (1993) Stat Med , vol.12 , pp. 835-842
    • Lin, D.Y.1    Fischl, M.A.2    Schoenfeld, D.A.3
  • 16
    • 0026573094 scopus 로고
    • Statistical validation of intermediate endpoints for chronic diseases
    • Freedman LS, Graubard BL, Schatzkin A: Statistical validation of intermediate endpoints for chronic diseases. Stat Med 1993, 11:167-178.
    • (1993) Stat Med , vol.11 , pp. 167-178
    • Freedman, L.S.1    Graubard, B.L.2    Schatzkin, A.3
  • 17
    • 0030777744 scopus 로고    scopus 로고
    • Meta-analysis for the evaluation of potential surrogate markers
    • Daniels MJ, Hughes MD: Meta-analysis for the evaluation of potential surrogate markers. Stat Med 1997, 16:1965-1982.
    • (1997) Stat Med , vol.16 , pp. 1965-1982
    • Daniels, M.J.1    Hughes, M.D.2
  • 18
    • 0025048319 scopus 로고
    • A randomized controlled trial of a reduced daily dose of zidovudine in patients with acquired immunodeficiency syndrome
    • Fischl MA, Parker CB, Pettinelli C, et al.: A randomized controlled trial of a reduced daily dose of zidovudine in patients with acquired immunodeficiency syndrome. N Engl J Med 1990, 323:1009-1014.
    • (1990) N Engl J Med , vol.323 , pp. 1009-1014
    • Fischl, M.A.1    Parker, C.B.2    Pettinelli, C.3
  • 19
    • 0025314920 scopus 로고
    • The safely and efficacy of zidovudine in the treatment of subjects with mildly symptomatic human immunodeficiency virus type I (HIV) infection
    • Fischl MA, Richman DD, Hansen N, et al.: The safely and efficacy of zidovudine in the treatment of subjects with mildly symptomatic human immunodeficiency virus type I (HIV) infection. Ann Intern Med 1990, 112:727-737.
    • (1990) Ann Intern Med , vol.112 , pp. 727-737
    • Fischl, M.A.1    Richman, D.D.2    Hansen, N.3
  • 20
    • 0025238899 scopus 로고
    • Zidovudine in asymptomatic human immunodeficiency virus infection: A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter
    • Volberding PA, Lagakos SW, Koch MA, et al.: Zidovudine in asymptomatic human immunodeficiency virus infection: a controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. N Engl J Med 1990, 322:941-949.
    • (1990) N Engl J Med , vol.322 , pp. 941-949
    • Volberding, P.A.1    Lagakos, S.W.2    Koch, M.A.3
  • 21
    • 0028049465 scopus 로고
    • The duration of zidovudine benefit in persons with asymptomatic HIV infection: Prolonged evaluation of protocol 019 of the AIDS Clinical Trials Group
    • Volberding PA, Lagakos SW, Grimes JM, et al.: The duration of zidovudine benefit in persons with asymptomatic HIV infection: prolonged evaluation of protocol 019 of the AIDS Clinical Trials Group. JAMA 1994, 272:437-442.
    • (1994) JAMA , vol.272 , pp. 437-442
    • Volberding, P.A.1    Lagakos, S.W.2    Grimes, J.M.3
  • 22
    • 0029099154 scopus 로고
    • Immediate versus deferred zidovudine in asymptomatic HIV-infected subjects with CD4 cell counts of 500 per microliter or greater
    • Volberding PA, Lagakos SW, Grimes JM, et al.: Immediate versus deferred zidovudine in asymptomatic HIV-infected subjects with CD4 cell counts of 500 per microliter or greater. N Engl J Med 1995, 333:401-413.
    • (1995) N Engl J Med , vol.333 , pp. 401-413
    • Volberding, P.A.1    Lagakos, S.W.2    Grimes, J.M.3
  • 23
    • 0026042216 scopus 로고
    • Placebo-controlled trial to evaluate zidovudine in treatment of human immunodeficiency virus infection in asymptomatic patients with hemophilia
    • Merigan TC, Amato DA, Balsley J, et al.: Placebo-controlled trial to evaluate zidovudine in treatment of human immunodeficiency virus infection in asymptomatic patients with hemophilia. Blood 1991, 4:900-906.
    • (1991) Blood , vol.4 , pp. 900-906
    • Merigan, T.C.1    Amato, D.A.2    Balsley, J.3
  • 24
    • 4243703741 scopus 로고    scopus 로고
    • The efficacy of zalcitabine (ddC, HIVID) versus zidovudine (ZDV) as monotherapy in ZDV naive patients with advanced HIV disease: A randomized, double-blind, comparative trial (ACTG 114; N3300)
    • Berlin, June 1993 [abstract PO-B26-2113]
    • Follansbee S, Drew L, Olson R, Pollard R, Welter W, Salgo M: The efficacy of zalcitabine (ddC, HIVID) versus zidovudine (ZDV) as monotherapy in ZDV naive patients with advanced HIV disease: a randomized, double-blind, comparative trial (ACTG 114; N3300). IX International Conference on AIDS. Berlin, June 1993 [abstract PO-B26-2113].
    • IX International Conference on AIDS
    • Follansbee, S.1    Drew, L.2    Olson, R.3    Pollard, R.4    Welter, W.5    Salgo, M.6
  • 25
    • 0028798335 scopus 로고
    • Health status and function with zidovudine or zalcitabine as initial therapy for AIDS
    • Bozzette SA, Kanouse DE, Berry S, Duan N, for the Roche 3300/ACTG 114 Study Group: Health status and function with zidovudine or zalcitabine as initial therapy for AIDS. JAMA 1995, 273:295-301.
    • (1995) JAMA , vol.273 , pp. 295-301
    • Bozzette, S.A.1    Kanouse, D.E.2    Berry, S.3    Duan, N.4
  • 26
    • 0028906281 scopus 로고
    • Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine
    • Dolin R, Amato DA, Fischl MA, et al.: Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. Arch Intern Med 1995, 155:961-974.
    • (1995) Arch Intern Med , vol.155 , pp. 961-974
    • Dolin, R.1    Amato, D.A.2    Fischl, M.A.3
  • 27
    • 0026732684 scopus 로고
    • A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection
    • Kahn JO, Lagakos SW, Richman DD, et al.: A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. N Engl J Med 1992, 327:581-587.
    • (1992) N Engl J Med , vol.327 , pp. 581-587
    • Kahn, J.O.1    Lagakos, S.W.2    Richman, D.D.3
  • 29
    • 0027309149 scopus 로고
    • Zalcitabine compared with zidovudine in patients with advanced HIV-1 infection who received previous zidovudine therapy
    • Fischl MA, Olson RM, Follansbee SL, et al.: Zalcitabine compared with zidovudine in patients with advanced HIV-1 infection who received previous zidovudine therapy. Ann Intern Med 1993, 118:762-769.
    • (1993) Ann Intern Med , vol.118 , pp. 762-769
    • Fischl, M.A.1    Olson, R.M.2    Follansbee, S.L.3
  • 30
    • 0028837503 scopus 로고
    • Combination and monotherapy with zidovudine and zalcitabine in patients with advance HIV disease
    • Fischl MA, Stanley K, Collier AC, et al.: Combination and monotherapy with zidovudine and zalcitabine in patients with advance HIV disease. Ann Intern Med 1995, 122:24-32.
    • (1995) Ann Intern Med , vol.122 , pp. 24-32
    • Fischl, M.A.1    Stanley, K.2    Collier, A.C.3
  • 31
    • 2442723342 scopus 로고    scopus 로고
    • Treatment of immunodeficiency virus infection with saquinavir, zidovudine and zalcitabine
    • Collier AC, Coombs RW, Schoenfeld DA, et al.: Treatment of immunodeficiency virus infection with saquinavir, zidovudine and zalcitabine. N Engl J Med 1996, 334:1011-1017.
    • (1996) N Engl J Med , vol.334 , pp. 1011-1017
    • Collier, A.C.1    Coombs, R.W.2    Schoenfeld, D.A.3
  • 32
    • 0030317268 scopus 로고    scopus 로고
    • Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial
    • D'Aquila RT, Hughes MD, Johnson VA, et al.: Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1996, 124:1019-1031.
    • (1996) Ann Intern Med , vol.124 , pp. 1019-1031
    • D'Aquila, R.T.1    Hughes, M.D.2    Johnson, V.A.3
  • 33
    • 0023653269 scopus 로고
    • Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome
    • Centers for Disease Control: Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR 1987, 36 (suppl 1):1S-15S.
    • (1987) MMWR , vol.36 , Issue.1 SUPPL.
  • 34
    • 0027122957 scopus 로고
    • 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults
    • Centers tor Disease Control: 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992, 41 (RR-17):1-19.
    • (1992) MMWR , vol.41 , Issue.RR-17 , pp. 1-19
  • 35
    • 0027375009 scopus 로고
    • Guideline for flow cytometric immunophenotyping: A report from the National Institute of Allergy and Infectious Diseases, Division of AIDS
    • Calvelli I, Denny TN, Paxton H, Gelman R, Kagan J: Guideline for flow cytometric immunophenotyping: a report from the National Institute of Allergy and Infectious Diseases, Division of AIDS. Cytometry 1993, 14:702-715.
    • (1993) Cytometry , vol.14 , pp. 702-715
    • Calvelli, I.1    Denny, T.N.2    Paxton, H.3    Gelman, R.4    Kagan, J.5
  • 36
    • 0027470070 scopus 로고
    • Assessment of the effects of instrumentation, monoclonal antibody, and fluorochrome on flow cytometric immunophenotyping: A report based on 2 years of the NIAID DAIDS flow cytometry quality assessment program
    • Gelman R, Cheng SC, Kidd P, Waxdal M, Kagan J: Assessment of the effects of instrumentation, monoclonal antibody, and fluorochrome on flow cytometric immunophenotyping: a report based on 2 years of the NIAID DAIDS flow cytometry quality assessment program. Clin Immunol Immunopathol 1993, 66:150-162.
    • (1993) Clin Immunol Immunopathol , vol.66 , pp. 150-162
    • Gelman, R.1    Cheng, S.C.2    Kidd, P.3    Waxdal, M.4    Kagan, J.5
  • 37
    • 0030771191 scopus 로고    scopus 로고
    • Estimating the proportion of treatment effect explained by a surrogate marker
    • Lin DY, Fleming TR, DeGruttola V: Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med 1997, 16:1515-1527.
    • (1997) Stat Med , vol.16 , pp. 1515-1527
    • Lin, D.Y.1    Fleming, T.R.2    DeGruttola, V.3
  • 38
    • 0030058515 scopus 로고    scopus 로고
    • Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS
    • O'Brien WA, Hartigan PM, Martin D, et al.: Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. N Engl J Med 1996, 334:426-431.
    • (1996) N Engl J Med , vol.334 , pp. 426-431
    • O'Brien, W.A.1    Hartigan, P.M.2    Martin, D.3
  • 41
    • 0344172588 scopus 로고    scopus 로고
    • Can HIV-1 RNA viral load be used as a surrogate for clinical endpoints in HIV disease?
    • Hamburg, October [abstract 103]
    • Babiker A, for the DELTA Coordinating Committee and Virology Group: Can HIV-1 RNA viral load be used as a surrogate for clinical endpoints in HIV disease? Sixth European Conference on Clinical Aspects and Treatment of HIV Infection. Hamburg, October 1997 [abstract 103].
    • (1997) Sixth European Conference on Clinical Aspects and Treatment of HIV Infection.
    • Babiker, A.1
  • 42
    • 85038551777 scopus 로고    scopus 로고
    • Meta-analysis to investigate the value of HIV RNA level and CD4 cell count as surrogate endpoints for evaluating treatments
    • Harmburg, October [abstract 328]
    • Kim S, for the HIV Surrogate Marker Collaborative Group: Meta-analysis to investigate the value of HIV RNA level and CD4 cell count as surrogate endpoints for evaluating treatments. Sixth European Conference on Clinical Aspects and Treatment of HIV Infection. Harmburg, October 1997 [abstract 328].
    • (1997) Sixth European Conference on Clinical Aspects and Treatment of HIV Infection
    • Kim, S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.