Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients

AIDS

Volumn 10, Issue 9, 1996, Pages 975-981

  Kuritzkes, Daniel R ^a,e   Quinn, Joseph B ^b   Benoit, Sharon L ^b,d   Shugarts, David L ^a   Griffin, Aaron ^a   Bakhtiari, Minoo ^a   Poticha, David ^a   Eron, Joseph J ^c   Fallon, Mary Ann ^b,d   Rubin, Marc ^b  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b GLAXOSMITHKLINE   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d LAB Biopharmaceutical Intl   (United States)

^e UNIVERSITY OF COLORADO   (United States)

Author keywords

Drug resistance; HIV; Lamivudine; Syncytium inducing phenotype; Zidovudine

Indexed keywords

ANTIVIRUS AGENT; LAMIVUDINE; VIRUS RNA; ZIDOVUDINE;

ADULT; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MONONUCLEAR CELL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; VIRUS CULTURE; VIRUS RESISTANCE;

EID: 8944256865     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-199610090-00007     Document Type: Article

References (37)

1. Gao Q, Gu Z, Hiscott J, Dionne G, Wainberg MA: Generation of drug-resistant variants of human immunodeficiency virus type 1 by in vitro passage in increasing concentrations of 2′,3′-dideoxycytidine and 2′,3′-dideoxy-3′-thiacytidine. Antimicrob Agents Chemother 1993, 37:130-133
2. Boucher CAB, Cammack N, Schipper P, et al.: High-level resistance to (-) enantiomeric 2′-deoxy-3′-thiacytidine in vitro is due to one amino acid substitution in the catalytic site of human immunodeficiency virus type 1 reverse transcriptase. Antimicrob Agents Chemother 1993, 37:2231-2234.
3. Tisdale M, Kemp SD, Parry NR, Larder BA: Rapid in vitro selection of human immunodeficiency virus type 1 resistant to 3′-thiacytidine inhibitors due to a mutation in the YMDD region of reverse transcriptase. Proc Natl Acad Sci USA 1993, 90:5653-5656.
4. Schinazi RF, Lloyd RM, Nguyen MH, et al.: Characterization of human immunodeficiency viruses resistant to oxathiolanecytosine nucleosides. Antimicrob Agents Chemother 1993, 37:875-881.
5. Myers G, Korber B, Wain-Hobson S, Jeang KT, Henderson LE, Pavlakis GN (Eds): Human Retroviruses and AIDS 1994. A compilation and analysis of nucleic acid and amino acid sequences. Los Alamos: Los Alamos National Laboratory; 1994.
6. Wakefield JK, lahlonski SA, Morrow CD: In vitro enzymatic activity of human immunodeficiency virus type 1 reverse transcriptase mutants in the highly conserved YMDD amino acid motif correlates with the infectious potential of the proviral genome. J Virol 1992, 66:6806-6812.
7. Back NKT, Nijhuis M, Boucher CAB, et al.: Reduced in vitro polymerase activity of 3TC-resistanl reverse transcriptase enzymes. 3rd International Workshop on HIV Drug Resistance. Kauai, August 1994 [abstract 32].
8. Wilson JE, Caligan TB, Martin JL, et al.: Biochemical analysis of HIV-1 reverse transcriptase with mutations at Met 184 in the highly conserved YMDD region. 3rd International Workshop HIV Drug Resistance. Kauai, August 1994 [abstract 35].
9. Larder BA, Kemp SD, Harrigan PK: Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science 1995, 269:696-699.
10. Eron JJ, Benoit SL, Jemsek J, et ,al.: Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. N Engl J Med 1995, 333:1662-1669.
11. Hollinger FB, Bremer JW, Myers LE, Gold JWM, McQuay L: The NIH/NIAID/DAIDS/ACTG Virology Laboratories. Standardization of sensitive human immunodeficiency virus coculture procedures and establishment of a multicenter quality assurance program for the AIDS Clinical Trials Group. J Clin Microbiol 1992, 30:1787-1794.
12. Japour AJ, Mayers DL, Johnson VA, et al.: A standardized peripheral blood mononuclear cell culture assay for the determination of drug susceptiblities of clinical human immunodeficiency virus-1 (HIV-1) isolates. Antimicrob Agents Chemother 1993, 37:1095-1101.
13. Chou TC, Talalay P: Quantitative analysis of dose-effect relationships: the combined effects of multiple drugs or enzyme inhibitors. Adv Enzyme Reg 1984, 22:27-55.
14. Schuurman R, Nijhuis M, van Leeuwen R, et al.: Rapid changes in human immunodeficiency virus type 1 RNA load and appearance of drug-resistant virus populations in persons treated with lamivudine (3TC). J Infect Dis 1995, 171:1411-1419.
15. Japour AJ, Fiscus SA, Arduino JM, et al.: Standardized microtiter assay for the determination of syncytium-inducing phenotypes of clinical human immunodeficiency virus type-1 isolates. J Clin Microbiol 1994, 32:2291-2294.
16. Japour AJ, Welles S, D'Aquila RT, et al.: Prevalence and clinical significance of zidovudine resistance mutations in human immunodeficiency virus isolated from patients following long-term zidovudine treatment. J Infect Dis 1995, 171:1172-1179.
17. Larder BA, Boucher CAB: PCR detection of human immunodeficiency virus drug resistance mutations. In Diagnostic Molecular Microbiology. Edited by Persing DH, Smith TF, Tenover FC, White TJ. Washington, DC: American Society for Microbiology; 1993:527-535.
18. Larder BA, Darby G, Richman DD: HIV with reduced sensitivity to zidovudine isolated during prolonged therapy. Science 1989, 243:1731-1734.
19. Dawson JD: Comparing treatment groups on the basis of slopes, areas-under-the-curve, and other summary measures. Drug Info J 1994, 28:723-732.
20. Boucher CAB, O'Sullivan E, Mulder JW, et al.: Ordered appearance of zidovudine resistance mutations during treatment of 18 human immunodeficiency virus-positive subjects. J Infect Dis 1992, 165:105-110.
21. 3. 2nd National Conference on Human Retroviruses. Washington DC, January 1995 [abstract LB31].
22. 3. 2nd National Conference Human Retroviruses. Washington, DC, January 1995 [abstract LB32].
23. 3. 2nd National Conference on Human Retroviruses. Washington, DC, January 1995 [abstract LB35].
24. de Jong MD, Veenstra J, Stilianakis N, et al.: Return to baseline values of HIV-1 RNA load during zidovudine treatment is associated with the emergence of K70R mutant virus. 4th Int Workshop on HIV Drug Resistance. Sardinia, July 1995 [abstract 20].
25. Larder BA, Kellam P, Kemp SD: Zidovudine resistance predicted by direct detection of mutations in DNA from HIV-infected lymphocytes. AIDS 1991, 5:137-144.
26. Wainberg MA, Drosopoulos WC, Salomon H. et al.: Enhanced fidelity of 3TC-selected mutant HIV-1 reverse transcriptase. Science 1996, 271:1282-1285.
27. Goulden MG, Hopewell P, Viner KC, Cammark NC, Penn CR, Cameron JM: Selection of high-level resistance to both AZT and 3TC. 4th International Workshop on HIV Drug Resistance. Sardinia, July 1995 [abstract 50].
28. Nijhuis M, de Jong D, van Leeuwen R, et al.: The rise in HIV-1 RNA load during 3TC/AZT combination therapy is associated with the selection of viruses resistant to both 3TC and AZT. 4th lnternational Workshop HIV Drug Resistance. Sardinia, July 1995 [abstract 52].
29. Kemp SD, Kohli A, Larder BA: Genotypic characterisation of an HIV-1 mutant co-resistant to AZT and 3TC. 4th International Workshop on HIV Drug Resistance. Sardinia, July 1995 [abstract 51].
30. 1). 4th International Workshop on HIV Drug Resistance. Sardinia, July 1995 [abstract 55].
31. Wei X, Ghosh SK, Taylor ME, et al.: Viral dynamics in human immunodeficiency virus type 1 infection. Nature 1995 373:117-122.
32. Koot M, Keel IPM, Vos AHV, et al.: Prognostic value of HIV-1 syncytium-inducing phenotype for rate of CD4+ cell depletion and progression to AIDS. Ann Intern Med 1993, 118:681-688.
33. Richman DD, Bozzette SA: The impact of the syncytium-inducing phenotype of human immunodeficiency virus on disease progression. J Infect Dis 1994, 169:968-974.
34. D'Aquila RT, Johnson VA, Welles SL, et al.: Zidovudine resistance and human immunodeficiency virus type 1 disease progression during antiretroviral therapy. Ann Intern Met 1995, 122, 401-408.
35. Kool M, Schellekens PTA, Mulder JW, et. al.: Viral phenotype and T cell reactivity in human immunodeficiency virus type 1-infected asymptomatic men treated with zidovudine. J Infect Dis 1993, 168:733-736.
36. Schooley RT, Ramirez-Ronda C, Lange JMA. et al.: Virologic and immunologic benefits of initial combination therapy with zidovudine and zalcitabine or didanosine compared to zidovudine monotherapy. J Infect Dis 1996, 173:1354-1366.
37. Kozal MJ, Shafer RW, Winters MS, et al.: HIV-1 syncytium-inducing phenotype, virus burden, codon 215 reverse transcriptase mutation and CD4 cell decline in zidovudine-treated patients. J Acquir Immune Defic Syndr 1994, 7:832-838.