Estimates of the virological benefit of antiretroviral therapy are both assay- and analysis-dependent

AIDS

Volumn 12, Issue 16, 1998, Pages 2185-2192

  Rae, Sandra ^a   Raboud, Janet M ^a   Conway, Brian ^a   Reiss, Peter ^b   Vella, Stephano ^c   Cooper, David ^d   Lange, Joep ^b   Harris, Marianne ^a   Wainberg, Mark A ^e   Robinson, Patrick ^f   Myers, Maureen ^f   Hall, David ^f   Montaner, Julio S G ^a  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^d ST VINCENT S HOSPITAL   (Australia)

^e MCGILL UNIVERSITY   (Canada)

^f BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

HIV; Plasma viral load; Statistical analysis

Indexed keywords

ANTIRETROVIRUS AGENT; DIDANOSINE; NEVIRAPINE; VIRUS RNA; ZIDOVUDINE;

ARTICLE; ASSAY; BLOOD LEVEL; CLINICAL TRIAL; DATA ANALYSIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MULTICENTER STUDY; NONHUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VIROLOGY; VIRUS LOAD;

ANALYSIS OF VARIANCE; ANTI-HIV AGENTS; DATA INTERPRETATION, STATISTICAL; DIDANOSINE; HIV INFECTIONS; HIV-1; HUMANS; NEVIRAPINE; RNA, VIRAL; STATISTICS, NONPARAMETRIC; TIME FACTORS; VIRAL LOAD; ZIDOVUDINE;

EID: 7844232377     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-199816000-00014     Document Type: Article

References (19)

1. Carpenter CJJ, Fischl MA, Hammer SM, et al.: Antiretroviral therapy for HIV infection in 1998: updated recommendations of the International AIDS Society-USA Panel. JAMA 1998, 280:78-86.
2. Mellors JW, Munoz A, Giorgi JV, et al.: Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med 1997, 126:946-954.
3. Coombs RW, Welles SL, Hooper C, et al.: Association of plasma human immunodeficiency virus type 1 RNA level with risk of clinical progression in patients with advanced disease. J Infect Dis 1996, 174:704-712.
4. 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.
5. 3. JAMA 1998, 279:930-937.
6. Mulder J, Resnick R, Saget B, et al.: A rapid and simple method for extracting human immunodeficiency virus type 1 RNA from plasma: enhanced sensitivity. J Clin Microbiol 1997, 35:1278-1280.
7. Katzenstein DA, Hammer SM, Hughes MD, et al.: The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy of HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. N Engl J Med 1996, 335:1091-1098.
8. O'Brien WA, Hartigan PM, Daar ES, Simberkoff MS, Hamilton JD, VA Cooperative Study Group on AIDS: 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.
9. Harris M, Durakovic C, Rae S, et al.: A pilot study of nevirapine, indinavir and lamivudine among patients with advanced human immunodeficiency virus disease who have had failure of combination nucleoside therapy. J Infect Dis 1998, 177:1514-1520.
10. Harris M, Patenaude P, Cooperberg P, et al.: Correlation of viral load in plasma and lymph node tissue in HIV infection. J Infect Dis 1997, 176:1388-1392.
11. Phillips AN, Eron J, Bartlet J, et al.: Correspondence between the effect of zidovudine plus lamivudine on plasma HIV level CD4 lymphocyte count and the incidence of clinical disease in infected individuals. AIDS 1997, 11:169-175.
12. Hollander M, Wolfe DA: Nonparametric Statistical Methods. New York: John Wiley and Sons; 1973.
13. Raboud JM, Montaner JSG, Thorne A, Singer J, Schechter MT, Canadian HIV Trials Network A002 Study Group: Impact of missing data due to dropouts on estimates of the treatment effect in a randomized trial of antiretroviral therapy for HIV infected individuals. J Acquir Immune Defic Syndr 1996, 12:46-55.
14. Gillings D, Koch G: The application of the principle of intention-to-treat analysis in clinical trials. Drug Inform J 1991, 25:411-424.
15. Hornung RW, Reed LD: Estimation of average concentration in the presence of nondetectable values. Appl Occup Environ Hyg 1990, 5:46-51.
16. Raboud JM, Montaner JSG, Rae S, et al.: Suppression of plasma viral load below 20 copies/ml is needed to achieve a long term antiretroviral response. AIDS 1998, 12:1614-1624.
17. Kaufman D, Pantaleo G, Sudre P, Telenti A, Swiss HIV Cohort Study: CD4-cell count in HIV-1-infected individuals remaining viraemic with highly active antiretroviral therapy (HAART). Lancet 1998, 351:723-724.
18. Dawson JD: Comparing treatment groups on the basis of slopes, areas-under-the-curve, and other summary measures. Drug Inform J 1994, 28:723-732.
19. Paxton W, Coombs RW, McElrath MJ, et al.: Longitudinal analysis of quantitative virologic measures in human immunodeficiency virus-infected subjects with ≥ 400 CD4 lymphocytes: implications for applying measurements to individual patients. J Infect Dis 1997, 175:247-254.