Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection

Journal of Infectious Diseases

Volumn 179, Issue 4, 1999, Pages 808-816

  Murphy, Robert L ^a   Gulick, Roy M ^b   DeGruttola, Victor ^b   D'Aquila, Richard T ^b   Eron, Joseph J ^b   Sommadossi, Jean Pierre ^b   Currier, Judith S ^b   Smeaton, Laura ^b   Frank, Ian ^b   Caliendo, Angela M ^b   Gerber, John G ^b   Tung, Roger ^b   Kuritzkes, Daniel R ^b  

^a NORTHWESTERN UNIVERSITY   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; AMPRENAVIR; CREATINE KINASE; LAMIVUDINE; ZIDOVUDINE;

ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIPLOPIA; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG PROTEIN BINDING; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; VIRUS LOAD; VIRUS REPLICATION;

ADULT; ANTI-HIV AGENTS; CARBAMATES; CD4 LYMPHOCYTE COUNT; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HIV INFECTIONS; HUMANS; LAMIVUDINE; MALE; MIDDLE AGED; RNA, VIRAL; SULFONAMIDES; ZIDOVUDINE;

EID: 0032899327     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/314668     Document Type: Article

References (36)

1. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infections. N Engl J Med 1998; 338:853-60.
2. Mouton Y, Alfandari S, Valette M, et al. Impact of protease inhibitors on AIDS-defining events and hospitalisations in 10 French AIDS reference centers. AIDS 1997; 11:F101-5.
3. Kohl NE, Emini EA, Schleif WA, et al. Active human immunodeficiency virus protease is required for viral infectivity. Proc Natl Acad Sci USA 1988; 85:4686-90.
4. Peng C, Ho BK, Chang TW, Chang NT. Role of human immunodeficiency virus type 1 specific protease in core protein maturation and viral infectivity. J Virol 1989; 63:2550-6.
5. Seelmeier S, Schmidt H, Turk V, von der Helm K. Human immunodeficiency virus has an aspartic-type protease that can be inhibited by pepstatin A. Proc Natl Acad Sci USA 1988; 85:6612-6.
6. 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.
7. 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.
8. Cameron DW, Heath-Chiozzi M, Danner S, et al. Randomized placebo-controlled trial of ritonavir in advanced HIV-1 disease. Lancet 1998; 351: 543-9.
9. Powderly W, Sension M, Conant M, et al. The efficacy of Viracept (nelfinavir mesylate, NLF) in pivotal phase II/III double-blind randomised controlled trials as monotherapy and in combination with d4T or AZT/3TC [abstract 370]. In: 4th Conference on Retroviruses and Opportunistic Infections; program and abstracts (Washington, DC). Alexandria. VA: Infectious Diseases Society of America, 1997:132.
10. Clendeninn N. Quart B, Anderson R, Knowles M, Chang Y. Analysis of long-term virologic data from the Viracept (nelfinavir, NFV) 511 protocol using 3 HIV-RNA assays [abstract 372]. In: 5th Conference on Retroviruses and Opportunistic Infections: program and abstracts (Chicago). Alexandria, VA: Foundation for Retrovirology and Human Health, 1998: 148.
11. Collier AC, Coombs RW, Schoenfeld DA, et al. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group. N Engl J Med 1996: 334:1011-7.
12. Kim EE, Baker CT, Dwyer MD, et al. Crystal structure of HIV-1 protease in complex with VX-478, a potent and orally bioavailable inhibitor of the enzyme. J Am Chem Soc 1995; 117:1181-2.
13. Rao BG, Kim EE, Murcko MA. Calculation of solvation and binding free energy differences between VX-478 and its analogs by free energy perturbation and AMSOL methods. J Comput Aided Mol Des 1996; 10: 23-30.
14. Navia MA, Murcko MA. Use of structural information in drug design. Curr Opin Struct Biol 1992; 2:202-10.
15. Painter GR, Ching S, Reynolds D, et al. 141W94. Drugs Future 1996; 21: 347-50.
16. St Clair MH, Millard J, Rooney J, et al. In vitro antiviral activity of 141W94 (VX-478) in combination with other antiretroviral agents. Antivir Res 1996; 29:53-6.
17. Livington DL, Pazhanisamy S, Porter DT, et al. Weak binding of VX-478 to human plasma proteins and implications for anti human immunodeficiency virus therapy. J Infect Dis 1995; 172:1238-45.
18. Gooding AE, Hsieh A, Woolley JL. Plasma protein binding and erythrocyte partitioning studies in rats, dogs and humans with the HIV-1 protease inhibitor, 141W94 (VX-478) [abstract 347]. In: Program and abstracts of the 7th International Meeting of the Society for the Study of Xenobiotics (San Diego, CA). Cabin John, MD: North American International Society for the Study of Xenobiotics, 1996:347.
19. 1-acid glycoprotein on the anti-human immunodeficiency virus (HIV) activity of the protease inhibitor CGP 61775: a comparative study with other relevant HIV protease inhibitors. J Infect Dis 1997; 175:1063-70.
20. Sadler BH, Elkins M, Hanson C, et al. The safety and pharmacokinetics of 141W94: an HIV protease inhibitor [abstract 564]. In: Program and abstracts of the 5th European Conference on Clinical Aspects and Treatment of HIV Infection (Copenhagen). European AIDS Clinical Society, 1995: 90.
21. Tisdale M, Myers RE, Maschera B, Parry NR, Oliver NM, Blair FD. Cross - resistance analysis of human immunodeficiency virus type 1 variants selected for resistance to five different protease inhibitors. Antimicrob Agents Chemother 1995; 39:1704-10.
22. Partaledis JA, Yamagouchi K, Tisdale M, et al. In vitro selection and characterization of human immunodeficiency virus type 1 (HIV-1) isolates with reduced sensitivity to potent sulfonamide inhibitors of HIV-1 aspartyl protease. J Virol 1995; 69:5228-35.
23. 1 [abstract LB 7A]. In: Program and abstracts of the 36th Interscience Conference on Anti- microbial Agents and Chemotherapy (New Orleans). Washington, DC: American Society for Microbiology, 1996:Late Breaker 8.
24. Haubrich R. Phase 2 study of amprenavir, a novel protease inhibitor, in combination with zidovudine/3TC [abstract 12321]. In: Conference record of the 12th World AIDS Conference (Geneva). Stockholm: International AIDS Society, 1998:77.
25. + counts >400 cells/μL and viral load >5000 copies/mL [abstract 12204]. In: Conference record of the 12th World AIDS Conference (Geneva). Stockholm: International AIDS Society, 1998:52.
26. Marschner I, Betensky RA, Degruttola V, Kuritzkes DR. Biases in the assessment of viral load reduction in HIV clinical trials [abstract 42149]. In: Conference record of the 12th World AIDS Conference (Geneva). Stockholm: International AIDS Society, 1998:802.
27. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York: Wiley & Sons, 1980.
28. Cox DR, Oakes D. Analysis of survival data. New York: Chapman and Hall, 1984.
29. Wei X, Ghosh SK, Taylor ME, et al. Viral dynamics in human immunodeficiency virus type 1 infection. Nature 1995; 373:117-22.
30. Ho DD, Neumann AU, Perelson AS, et al. Rapid turnover of plasma virions and CD4 lymphocytes in HIV infection. Nature 1995; 373:123-6.
31. Perelson AS, Neumann AU, Markowitz M, et al. HIV-1 dynamics in vivo: virion clearance rate, infected life-span, and viral generation time. Science 1996; 271:1582-6.
32. Coffin JM. HIV population dynamics in vivo: implications for genetic variation, pathogenesis and therapy. Science 1995; 267:483-9.
33. Condra JH, Schleif WA, Blahy OM, et al. In vivo emergence of HIV-1 variants resistant to multiple protease inhibitors. Nature 1995; 374:569-71.
34. DePasquale MP, Murphy R, Gulick R, et al. Mutations selected in plasma HIV plasma during 141W94 therapy [abstract 406a]. In: the 5th Conference on Retroviruses and Opportunistic Infections: program and abstracts (Chicago). Alexandria, VA: Foundation for Retrovirology and Human Health, 1998:155.
35. Caliendo AM, Savara A, An D, DeVore K, Kaplan JC, D'Aquila RT. Effects of zidovudíne-selected human immunodeficiency virus type 1 reverse transcriptase amino acid substitutions on processive DNA synthesis and viral replication. J Virol 1996; 70:2146-53.
36. 1-acid glycoprotein levels in AIDS patients before and after short-term treatment with zidovudine (ZDV). J Acquir Immune Defic Syndr 1993; 6:531-33.