An approach to the validation of markers for use in AIDS clinical trials

Clinical Infectious Diseases

Volumn 24, Issue 5, 1997, Pages 764-774

  Mildvan, Donna ^a   Landay, Alan ^b   De Gruttola, Victor ^b   Machado, Stella G ^b   Kagan, Jonathan ^b  

^a BETH ISRAEL MEDICAL CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AL 721; ANTIGEN P24; ANTIRETROVIRUS AGENT; BETA 2 MICROGLOBULIN; BIOLOGICAL MARKER; CD28 ANTIGEN; CD38 ANTIGEN; CD4 ANTIGEN; CD45 ANTIGEN; CD8 ANTIGEN; DIDANOSINE; INTERFERON; INTERLEUKIN 6; NEOPTERIN; PLACEBO; TELINAVIR; TRIACYLGLYCEROL; TUMOR NECROSIS FACTOR RECEPTOR; VIRUS RNA; ZALCITABINE; ZIDOVUDINE; [7 CHLORO 5 (1H PYRROL 2 YL) 3H BENZO[E][1,4]DIAZEPIN 2 YL]METHYLAMINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; BODY MASS; CLINICAL PROTOCOL; CLINICAL TRIAL; DISEASE MARKER; DRUG EFFICACY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; NOTE; PRIORITY JOURNAL; PROGNOSIS; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL;

EID: 0031000842     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1093/clinids/24.5.764     Document Type: Note

References (15)

1. 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;3:1065-73.
2. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-13.
3. Weiss R, Mazade H, eds. Surrogate endpoints in evaluating the effectiveness of drugs against HIV infection and AIDS. Institute of Medicine conference summary. Washington, DC: National Academy Press, 1990.
4. Moss AR. Laboratory markers as potential surrogates for clinical outcomes in AIDS trials. J Acquir Immune Defic Syndr 1990;3(suppl 2): S69-71.
5. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-40.
6. Fischl MA, Richman DD, Grieco MH, et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex: a double-blind placebo-controlled trial. N Engl J Med 1987; 317:185-91.
7. Moore RD, Keruly J, Richman DD, Creagh-Kirk T, Chaisson RE. Natural history of advanced HIV disease in patients treated with zidovudine. The Zidovudine Epidemiology Study Group. AIDS 1992;6:671-7.
8. Fischl MA, Richman DD, Hansen N, et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection: a double-blind placebo-controlled trial. Ann Intern Med 1990;112:727-37.
9. 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;322:941-9.
10. Polk BF, Fox R, Brookmeyer R, et al. Predictors of the acquired immuno-deficiency syndrome developing in a cohort of seropositive homosexual men. N Engl J Med 1987;316:61-6.
11. Goedert JJ, Biggar RJ, Melbye M, et al. Effect of T4 count and cofactors on the incidence of AIDS in homosexual men infected with human immunodeficiency virus. JAMA 1987;257:331-4.
12. Moss AR, Bacchetti P, Osmond D, et al. Seropositivity for HIV and the development of AIDS or AIDS-related condition: three-year follow-up of the San Francisco General Hospital cohort. BMJ 1988;296: 745-50.
13. Lange JMA, de Wolf F, Goudsmit J. Markers for progression in HIV infection. AIDS 1989;3(suppl 1):S153-60.
14. Fahey JL, Taylor JMG, Detels R, et al. The prognostic value of cellular and serologic markers in infection with human immunodeficiency virus type 1. N Engl J Med 1990;322:166-72.
15. 2 microglobulin level and CD4 lymphocyte count to predict development of acquired immunodeficiency syndrome in persons with human immunodeficiency virus infection. Arch Intern Med 1990;150: 73-7.