메뉴 건너뛰기




Volumn 7, Issue 3, 2006, Pages 125-141

Reporting and evaluaton of HIV-related clinical endpoints in two multicenter international clinical trials

(29)  Lifson, Alan R a   Rhame, Frank S b   Belloso, Waldo H c   Dragsted, Ulrik B d   El Sadr, Wafaa M e   Gatell, Jose M f   Hoy, Jennifer F g   Krum, Eric A a   Nelson, Ray a   Pedersen, Court h   Pett, Sarah L i   Davey Jr , Richard T j   Neaton, James k   Abrams, Donald k   Cahn, Pedro k   Clotet, Bonaventura k   Cooper, David k   Darbyshire, Janet k   Sandra, Lehrman k   Emery, Sean k   more..


Author keywords

Clinical endpoints; Clinical trials; Human immunodeficiency virus

Indexed keywords

ANTIRETROVIRUS AGENT; RECOMBINANT INTERLEUKIN 2; INTERLEUKIN 2;

EID: 33748155708     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/7MER-XFA7-1762-E2WR     Document Type: Article
Times cited : (20)

References (29)
  • 1
    • 0027409691 scopus 로고
    • Surrogate markers in AIDS clinical trials: Conceptual basis, validation, and uncertainties
    • Lagakos SW. Surrogate markers in AIDS clinical trials: conceptual basis, validation, and uncertainties. Clin Infect Dis. 1993;16(suppl 1):S22-25.
    • (1993) Clin Infect Dis. , vol.16 , Issue.SUPPL. 1
    • Lagakos, S.W.1
  • 2
    • 0031029644 scopus 로고    scopus 로고
    • Perspective: Validating surrogate markers - Are we being naive?
    • De Gruttola V, Fleming T, Lin DY, Coombs R. Perspective: validating surrogate markers - Are we being naive? J Infect Dis. 1997;175:237-246.
    • (1997) J Infect Dis. , vol.175 , pp. 237-246
    • De Gruttola, V.1    Fleming, T.2    Lin, D.Y.3    Coombs, R.4
  • 3
    • 0034632793 scopus 로고    scopus 로고
    • Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate endpoints: A meta-analysis
    • HIV Surrogate Marker Collaborative Group
    • HIV Surrogate Marker Collaborative Group. Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate endpoints: a meta-analysis. AIDS Res Hum Retroviruses. 2000;16:1123-1133.
    • (2000) AIDS Res Hum Retroviruses , vol.16 , pp. 1123-1133
  • 4
    • 0028344275 scopus 로고
    • Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection
    • Concorde Coordinating Committee
    • Concorde Coordinating Committee. Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet. 1994;343:871-881.
    • (1994) Lancet , vol.343 , pp. 871-881
  • 5
    • 33747139096 scopus 로고    scopus 로고
    • Episodic CD4-guided use of ART is inferior to continuous therapy: Results of the SMART study
    • Paper presented at: February Denver, CO. Abstract 106LB
    • El-Sadr W, Neaton J. Episodic CD4-guided use of ART is inferior to continuous therapy: results of the SMART study. Paper presented at: 13th Conference on Retroviruses and Opportunistic Infections; February 2006; Denver, CO. Abstract 106LB.
    • (2006) 13th Conference on Retroviruses and Opportunistic Infections
    • El-Sadr, W.1    Neaton, J.2
  • 6
    • 0004781509 scopus 로고    scopus 로고
    • Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy: A randomized controlled trial
    • Davey RT, Murphy RL, Graziano FM, et al. Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy: a randomized controlled trial. JAMA. 2000;284:183-189.
    • (2000) JAMA , vol.284 , pp. 183-189
    • Davey, R.T.1    Murphy, R.L.2    Graziano, F.M.3
  • 7
    • 0036184673 scopus 로고    scopus 로고
    • Immune-based therapies: A review of clinical endpoints used in trials of selected immunologic agents
    • Forum for Collaborative HIV Research
    • Forum for Collaborative HIV Research. Immune-based therapies: a review of clinical endpoints used in trials of selected immunologic agents. HIV Clin Trials. 2002;3:58-88.
    • (2002) HIV Clin Trials , vol.3 , pp. 58-88
  • 8
    • 84938476149 scopus 로고
    • Considerations in the selection of end points for AIDS clinical trials
    • Amato DA, Lagakos SW. Considerations in the selection of end points for AIDS clinical trials. J Acquir Immune Defic Syndr. 1990;3(suppl 2):S64-68.
    • (1990) J Acquir Immune Defic Syndr. , vol.3 , Issue.SUPPL. 2
    • Amato, D.A.1    Lagakos, S.W.2
  • 9
    • 7844243605 scopus 로고    scopus 로고
    • Experience with a cross-study endpoint review committee for AIDS clinical trials
    • Green LA, Rhame FS, Price RW, et al. Experience with a cross-study endpoint review committee for AIDS clinical trials. AIDS. 1998;12:1983-1990.
    • (1998) AIDS , vol.12 , pp. 1983-1990
    • Green, L.A.1    Rhame, F.S.2    Price, R.W.3
  • 10
    • 0027122957 scopus 로고
    • 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults
    • Centers for Disease Control and Prevention. RR-17
    • Centers for Disease Control and Prevention. 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 , pp. 1-19
  • 11
    • 0028076195 scopus 로고
    • Considerations in choice of a clinical endpoint for AIDS clinical trials
    • Neaton JD, Wentworth DN, Rhame F, et al. Considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med. 1994;13:2107-2125.
    • (1994) Stat Med. , vol.13 , pp. 2107-2125
    • Neaton, J.D.1    Wentworth, D.N.2    Rhame, F.3
  • 12
    • 0030002879 scopus 로고    scopus 로고
    • Natural history of opportunistic disease in an HIV-infected urban clinical cohort
    • Moore RD, Chaisson RE. Natural history of opportunistic disease in an HIV-infected urban clinical cohort. Ann Intern Med. 1996;124:633-642.
    • (1996) Ann Intern Med. , vol.124 , pp. 633-642
    • Moore, R.D.1    Chaisson, R.E.2
  • 13
    • 0032498691 scopus 로고    scopus 로고
    • The incidence of AIDS-defining illnesses in 4883 patients with human immunodeficiency virus infection
    • Mocroft A, Youle M, Phillips AN, et al. The incidence of AIDS-defining illnesses in 4883 patients with human immunodeficiency virus infection. Arch Intern Med. 1998;158:491-497.
    • (1998) Arch Intern Med. , vol.158 , pp. 491-497
    • Mocroft, A.1    Youle, M.2    Phillips, A.N.3
  • 15
    • 0027282103 scopus 로고
    • Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter
    • Cooper DA, Gatell JM, Kroon S, et al. Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. N Engl J Med. 1993; 329:297-303.
    • (1993) N Engl J Med. , vol.329 , pp. 297-303
    • Cooper, D.A.1    Gatell, J.M.2    Kroon, S.3
  • 17
    • 0035455598 scopus 로고    scopus 로고
    • Differences in difficulty adjudicating clinical events in patients with advanced HIV disease
    • Eisenbud R, Assmann SF, Kalish LA, et al. Differences in difficulty adjudicating clinical events in patients with advanced HIV disease. J Acquir Immune Defic Syndr. 2001;28:43-46.
    • (2001) J Acquir Immune Defic Syndr. , vol.28 , pp. 43-46
    • Eisenbud, R.1    Assmann, S.F.2    Kalish, L.A.3
  • 18
    • 33748167145 scopus 로고    scopus 로고
    • CD4 count increases in patients with CD4 counts of 50-300 treated with intermittent IL-2: Immunologic results from the Study of IL-2 in Combination with Active Antiretroviral Therapy (SILCAAT) Trial
    • Paper presented at: October Warsaw, Poland. Abstract F 14/3
    • Levy Y, Mitsuyasu R, Tambusi G, et al. CD4 count increases in patients with CD4 counts of 50-300 treated with intermittent IL-2: immunologic results from the Study of IL-2 in Combination with Active Antiretroviral Therapy (SILCAAT) Trial. Paper presented at: Ninth European AIDS Conference; October 2003; Warsaw, Poland. Abstract F 14/3.
    • (2003) Ninth European AIDS Conference
    • Levy, Y.1    Mitsuyasu, R.2    Tambusi, G.3
  • 19
    • 0036209488 scopus 로고    scopus 로고
    • The Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial: Rationale, design, and methods of ESPRIT
    • Emery S, Abrams DI, Cooper DA, et al. The Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002;23:198-220.
    • (2002) Control Clin Trials , vol.23 , pp. 198-220
    • Emery, S.1    Abrams, D.I.2    Cooper, D.A.3
  • 21
    • 0023781683 scopus 로고
    • The AIDS dementia complex
    • Price RW, Brew BJ. The AIDS dementia complex. J Infect Dis. 1988;158:1079-1083.
    • (1988) J Infect Dis. , vol.158 , pp. 1079-1083
    • Price, R.W.1    Brew, B.J.2
  • 22
    • 0039531299 scopus 로고
    • Boston: Little, Brown and Company
    • Rothman KJ. Modern Epidemiology. Boston: Little, Brown and Company;1986:84-89.
    • (1986) Modern Epidemiology , pp. 84-89
    • Rothman, K.J.1
  • 23
    • 0037872688 scopus 로고    scopus 로고
    • Composite outcomes in randomized trials: Greater precision but with greater uncertainty?
    • Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: Greater precision but with greater uncertainty? JAMA. 2003;289:2554-2559.
    • (2003) JAMA , vol.289 , pp. 2554-2559
    • Freemantle, N.1    Calvert, M.2    Wood, J.3    Eastaugh, J.4    Griffin, C.5
  • 24
    • 33645227163 scopus 로고    scopus 로고
    • Some issues with composite endpoints in clinical trials
    • Chi GYH. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol. 2005;19:609-619.
    • (2005) Fundam Clin Pharmacol. , vol.19 , pp. 609-619
    • Chi, G.Y.H.1
  • 25
    • 0035941525 scopus 로고    scopus 로고
    • Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas
    • Ioannidis JPA, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001;285:437-443.
    • (2001) JAMA , vol.285 , pp. 437-443
    • Ioannidis, J.P.A.1    Lau, J.2
  • 27
    • 2342656120 scopus 로고    scopus 로고
    • The need for adverse effects reporting standards in oncology clinical trials
    • Trotti A, Bentzen SM. The need for adverse effects reporting standards in oncology clinical trials. J Clin Oncol. 2004;22:19-22.
    • (2004) J Clin Oncol. , vol.22 , pp. 19-22
    • Trotti, A.1    Bentzen, S.M.2
  • 28
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: An extension of the CONSORT statement
    • Ioannidis JPA, Evans SJW, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781-788.
    • (2004) Ann Intern Med. , vol.141 , pp. 781-788
    • Ioannidis, J.P.A.1    Evans, S.J.W.2    Gotzsche, P.C.3
  • 29
    • 9944262983 scopus 로고    scopus 로고
    • Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis
    • Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet. 2004;364:2021-2029.
    • (2004) Lancet , vol.364 , pp. 2021-2029
    • Juni, P.1    Nartey, L.2    Reichenbach, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.