Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection

New England Journal of Medicine

Volumn 350, Issue 18, 2004, Pages 1850-1861

  Gulick, Roy M ^a,o   Ribaudo, Heather J ^b   Shikuma, Cecilia M ^c   Lustgarten, Stephanie ^b   Squires, Kathleen E ^d   Meyer III, William A ^e   Acosta, Edward P ^f   Schackman, Bruce R ^a   Pilcher, Christopher D ^g   Murphy, Robert L ^h   Maher, William E ⁱ   Witt, Mallory D ^j   Reichman, Richard C ^k   Snyder, Sally ^l   Klingman, Karin L ^m   Kuritzkes, Daniel R ⁿ  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF HAWAII   (United States)

^d LAC USC MEDICAL CENTER   (United States)

^e QUEST DIAGNOSTICS NICHOLS INSTITUTE   (United States)

^f UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^g UNIVERSITY OF NORTH CAROLINA   (United States)

^h NORTHWESTERN UNIVERSITY   (United States)

ⁱ OHIO STATE UNIVERSITY   (United States)

^j HARBOR UCLA MEDICAL CENTER   (United States)

^k UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^l SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

^m NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

ⁿ BRIGHAM AND WOMEN S HOSPITAL   (United States)

^o Cornell University   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; CD4 ANTIGEN; DIDANOSINE; EFAVIRENZ; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; NEVIRAPINE; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE INHIBITOR; STAVUDINE; VIDEX EC; VIRUS RNA; ZIDOVUDINE; 2',3' DIDEOXYNUCLEOSIDE DERIVATIVE; NUCLEOSIDE; OXAZINE DERIVATIVE;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESISTANCE; FEMALE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT FAILURE; VIROLOGIC FAILURE; ANTIBIOTIC RESISTANCE; BLOOD; CD4 LYMPHOCYTE COUNT; COMPARATIVE STUDY; DRUG COMBINATION; FOLLOW UP; GENETICS; MIDDLE AGED; MULTICENTER STUDY;

ADULT; AGED; CD4 LYMPHOCYTE COUNT; DIDEOXYNUCLEOSIDES; DOUBLE-BLIND METHOD; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HIV INFECTIONS; HIV-1; HUMANS; LAMIVUDINE; MALE; MIDDLE AGED; NUCLEOSIDES; OXAZINES; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; ZIDOVUDINE;

EID: 2342537759     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa031772     Document Type: Article

References (38)

1. Gulick RM, Mellors JW, Havlir D, et al. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med 1997;337:734-9.
2. 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;337:725-33.
3. Cameron DW, Heath-Chiozzi M, Danner S, et al. Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease. Lancet 1998;351:543-9.
4. Mouton Y, Alfandari S, Valette M, et al. Impact of protease inhibitors on AIDS-defining events and hospitalizations in 10 French AIDS reference centers. AIDS 1997; 11:F101-F105.
5. Palella FJ Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998;338:853-60.
6. Panel on Clinical Practices for Treatment of HIV Infection. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Rockville, Md.: AIDSinfo, November 10, 2003. (Accessed April 5, 2004, at http://www.aidsinfo.nih.gov/guidelines/adult/archive/AA_111003.html.)
7. Yeni PG, Hammer SM, Carpenter CC, et al. Antiretroviral treatment for adult HIV infection in 2002: updated recommendations of the International AIDS Society-USA Panel. JAMA 2002;288:222-35. [Erratum, JAMA 2003;289:32.]
8. Yeni PG, Hammer SM, Carpenter CC, et al. Antiretroviral treatment for adult HIV infection in 2002: updated recommendations of the International AIDS Society-USA Panel. JAMA 2002;288:222-35. [Erratum, JAMA 2003;289:32.]
9. Carr A, Samaras K, Burton S, et al. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS 1998;12:F51-F58.
10. Walli R, Herfort O, Michl GM, et al. Treatment with protease inhibitors associated with peripheral insulin resistance and impaired oral glucose tolerance in HIV-1-infected patients. AIDS 1998;12:F167-F173.
11. Mulligan K, Grunfeld C, Tai VW, et al. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV-1 infection. J Acquir Immune Defic Syndr 2000;23:35-43.
12. Staszewski S, Morales-Ramirez J, Tashima KT, et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. N Engl J Med 1999;341:1865-73.
13. Podzamczer D, Ferrer E, Consiglio E, et al. A randomized clinical trial comparing nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naive patients (the Combine Study). Antivir Ther 2002;7:81-90.
14. van Leeuwen R, Katlama C, Murphy RL, et al. A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients. AIDS 2003;17:987-99.
15. Trotta MP, Ammassari A, Cozzi-Lepri A, et al. Adherence to highly active antiretroviral therapy is better in patients receiving non-nucleoside reverse transcriptase inhibitor-containing regimens than in those receiving protease inhibitor-containing regimens. AIDS 2003;17:1099-102.
16. Henry K, Wallace RJ, Bellman PC, et al. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis 2001;183:571-8.
17. Kirkland LR, Fischl MA, Tashima KT, et al. Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment. Clin Infect Dis 2002;34:511-8.
18. Ait-Khaled M, Rakik A, Griffin P, et al. Mutations in HIV-1 reverse transcriptase during therapy with abacavir, lamivudine and zidovudine in HIV-1-infected adults with no prior antiretroviral therapy. Antivir Ther 2002;7:43-51.
19. Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: a randomized equivalence trial. JAMA 2001;285:1155-63. [Erratum, JAMA 2001;285:2858.]
20. Staszewski S, Keiser P, Montaner J, et al. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: a randomized equivalence trial. JAMA 2001;285:1155-63. [Erratum, JAMA 2001;285:2858.]
21. Vibhagool A, Cahn P, Schechter M, et al. Abacavir/combivir (ABC/COM) is comparable to indinavir/combivir in HIV-1 infected antiretroviral therapy naïve adults: preliminary results of a 48-week open label study (CNA3014). In: Final programme and abstracts of the 1st IAS Conference on HIV Pathogenesis and Treatment, Buenos Aires, Argentina, July 8-11, 2001:102. abstract.
22. Matheron S, Descamps D, Boue F, et al. Triple nucleoside combination zidovudine/lamivudine/abacavir versus zidovudine/lamivudine/nelfinavir as first-line therapy in HIV-1-infected adults: a randomized trial. Antivir Ther 2003;8:163-71.
23. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York: John Wiley, 1980.
24. Wei LJ, Johnson WE. Combining dependent tests with incomplete repeated measurements. Biometrika 1985;72:359-64.
25. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959;22:719-48.
26. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
27. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659-63.
28. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976;34:585-612.
29. Jennison C, Turnbull BW. Group sequential methods with applications to clinical trials. Boca Raton, Fla.: Chapman & Hall/CRC, 2000.
30. Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977;64:191-9.
31. Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naïve HIV-1 infected adults. AIDS 2001; 15:1369-77.
32. Bangsberg DR, Hecht FM, Charlebois ED, et al. Adherence to protease inhibitors, HIV-1 viral load, and development of drug resistance in an indigent population. AIDS 2000;14:357-66.
33. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30. [Erratum, Ann Intern Med 2002;136:253.]
34. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30. [Erratum, Ann Intern Med 2002;136:253.]
35. Trotta MP, Ammassari A, Melzi S, et al. Treatment-related factors and highly active antiretroviral therapy adherence. J Acquir Immune Defic Syndr 2002;31:Suppl 3: S128-S131.
36. Little SJ, Holte S, Routy J-P, et al. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med 2002; 347:385-94.
37. Grant RM, Hecht FM, Warmerdam M, et al. Time trends in primary HIV-1 drug resistance among recently infected persons. JAMA 2002;288:181-8.
38. Bacheler LT, Anton ED, Kudish P, et al. Human immunodeficiency virus type 1 mutations selected in patients failing efavirenz combination therapy. Antimicrob Agents Chemother 2000;44:2475-84.