The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination a review of North American (NUCA 3001) and European (NUCB 3001) trials

AIDS, Supplement

Volumn 10, Issue 5, 1996, Pages

  Eron Jr , Joseph J ^a,b  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

3TC; Combination therapy; Monotherapy; Zidovudine

Indexed keywords

ANTIGEN P24; ANTIVIRUS AGENT; CD4 ANTIGEN; LAMIVUDINE; VIRUS RNA; ZIDOVUDINE;

ADULT; ANOREXIA; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG TOLERABILITY; EUROPE; FATIGUE; FEMALE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; NAUSEA; NEUROPATHY; NORTH AMERICA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SLEEP DISORDER; VERTIGO; VIRUS RESISTANCE; VOMITING;

EID: 0030484637     PISSN: 13502840     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-199612005-00003     Document Type: Conference Paper

References (45)

1. Ho DD, Neumann AU, Perelson AS, et al.: Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infection. Nature 1995, 373:123-126.
2. Perelson A, Neumann A, Markowitz M, et al.: HIV-1 dynamic in vivo: virion clearance rate, infected cell life-span and viral generation time. Science 1996, 271:1167-1170.
3. Wei X, Ghosh SK, Taylor ME, et al.: Viral dynamics in human immunodeficiency virus type 1 infection. Nature 1995, 373:117-122.
4. Coffin JM: HIV population dynamics in vivo: implications for genetic variation, pathogenesis, and therapy. Science 1995, 267:483-489.
5. Cao Y, Qin L, Zhang L, et al.: Virologic and immunologic characterization of long-term survivors of human immunodeficiency virus type 1 infection. N Engl J Med 1995, 332:201-208.
6. Pantaleo G, Menzo S, Vaccarezza M, et al.: Studies in subjects with long-term nonprogressive human immunodeficiency virus infection. N Engl J Med 1995, 332:209-216.
7. Mellors JW, Kingsley LA, Rinaldo CR Jr, et al.: Quantitation of HIV-1 RNA in plasma predicts outcome after seroconversion. Ann Intern Med 1995, 122:573-579.
8. Mellors J, Rinaldo C, Gupta P, et al.: Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 1996, 272:1167-1170.
9. Henrard DR, Phillips JF, Muenz LR, et al.: Natural history of HIV-1 cell-free viremia. JAMA 1995, 274:554-558.
10. Hooper C, Welles S, D'Aquila R, et al.: HIV-1 RNA level in plasma and association with disease progression, zidovudine sensitivity phenotype and genotype, syncytium-inducing phenotype, CD4+ cell count and clinical diagnosis of AIDS. Third International Workshop on HIV Drug Resistance. Kaui, August 1994 [abstract 43].
11. Welles S, Jackson J, Yen-Lieberman B, et al.: Prognostic capacity of HIV-1 Plasma RNA copy number in ACTG 116A. Second National Conference on Human Retroviruses. Washington, DC, January 1995 [abstract 230].
12. O'Brien W, Hartigan P, Martin D, et al.: 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.
13. Ho DD: Time to hit HIV, early and hard [editorial; comment]. N Engl J Med 1995, 333:450-451.
14. Kinloch-De Loes S, Hirschel BJ, Hoen B, et al.: A controlled trial of zidovudine in primary human immunodeficiency virus infection. N Engl J Med 1995, 333:408-413.
15. Ioannidis JP, Cappelleri JC, Lau J, et al.: Early or deferred zidovudine therapy in HIV-infected patients without an AIDS-defining illness. Ann Intern Med 1995, 122:856-866.
16. Kahn JO, Lagakos SW, Richman DD, et al.: A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group. N Engl J Med 1992, 327:581-587.
17. Dolin R, Amato DA, Fischl MA, et al.: Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. AIDS Clinical Trials Group. Arch Intern Med 1995, 155:961-974.
18. Hammer S, Katzenstein D, Hughes M, et al.: A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. N Engl J Med 1996, 335:1081-1090.
19. Eron JJ, Chow YK, Caliendo AM, et al.: Pol mutations conferring zidovudine and didanosine resistance with different effects in vitro yield multiply resistant human immunodeficiency virus type 1 isolates in vivo. Antimicrob Agents Chemother 1993, 37: 1480-1487.
20. 3: results of a double-blind randomized placebo-controlled study. 3rd Conference on Retroviruses and Opportunistic Infections. Washington, DC, 1996 [abstract 196].
21. Caliendo AM, Hirsch MS: Combination therapy for infection due to human immunodeficiency virus type 1. Clin Infect Dis 1994, 18:516-524.
22. Delta Coordinating Committee: Delta: a randomized double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcibatine with zidovudine alone in HIV-infected individuals. Lancet 1996, 348:283-291.
23. Coates JA, Cammack N, Jenkinson HJ, et al.: (-)-2′-deoxy-3′-thiacytidine is a potent, highly selective inhibitor of human immunodeficiency virus type 1 and type 2 replication in vitro. Antimicrob Agents Chemother 1992, 36:733-739.
24. Hart GJ, Orr DC, Penn CR, et al.: Effects of (-)-2′-deoxy-3′-thiacytidine (3TC) 5′-triphosphate on human immunodeficiency virus reverse transcriptase and mammalian DNA polymerases alpha, beta, and gamma. Antimicrob Agents Chemother 1992, 36:1688-1694.
25. Cammack N, Rouse P, Marr CL, et al.: Cellular metabolism of (-) enantiomeric 2′-deoxy-3′-thiacytidine. Biochem Pharmacol 1992, 43:2059-2064.
26. Pluda JM, Cooley TP, Montaner JS, et al.: A phase I/II study of 2′-deoxy-3′-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection. J Infect Dis 1995, 171:1438-1447.
27. van Leeuwen R, Katlama C, Kitchen V, et al.: Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a phase I/II study. J Infect Dis 1995, 171:1166-1171.
28. 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.
29. Boucher CA, 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.
30. Wainberg MA, Salomon H, Cu Z, et al.: Development of HIV-1 resistance to (-)2′-deoxy-3′-thiacytidine in patients with AIDS or advanced AIDS-related complex. AIDS 1995, 9:351-357.
31. 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.
32. Katlama C, Ingrand D, Loveday C, et al.: Safety and efficacy of lamivudine/zidovudine combination therapy in antiretroviral-naive patients: a randomized controlled comparison with zidovudine monotherapy. JAMA 1996, 276:118-125.
33. Eron J, Benoit S, Jemsek J, et al.: Treatment with lamivudine, zidovudine or both in the treatment of HIV-positive patients with 200-500 CD4+ cells per cubic millimeter. N Engl J Med 1995, 333:1662-1669.
34. Dawson J: Comparing treatment groups on the basis of slopes, areas under-the-curve, and other summary measures. Drug Info J 1994, 28:723-732.
35. Semple M, Loveday C, Weller I, Tedder R: HIV plasma viraemia quantification: a non-culture measurement needed for therapeutic trials. J Virol Methods 1993, 41:167-180.
36. 3. 2nd National Conference on Human Retroviruses and Related Infections. Washington, DC, January 1995 [abstract LB35].
37. Stazewski S, Loveday C, Picazo J, et al.: Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients: a randomized controlled comparison with zidovudine monotherapy. JAMA 1996; 276:111-117.
38. Katzenstein D, Hammer S, Hughes M, et al.: Plasma virion RNA response to early antiretroviral drug therapy in ACTG 175: Do changes in virus load parallel clinical and immunologic outcomes? 35th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, September 1995 [abstract LB2].
39. Mathez D, Schinazi RF, Liotta DC, Leibowitch J: Infectious amplification of wild-type human immunodeficiency virus from patients' lymphocytes and modulation by reverse transcriptase inhibitors in vitro. Antimicrob Agents Chemother 1993, 37:2206-2211.
40. Gao WY, Shirasaka T, Johns DG, et al: Differential phosphorylation of azidothymidine, dideoxycytidine, and dideoxyinosine in resting and activated peripheral blood mononuclear cells. J Clin invest 1993, 91:2326-2333.
41. Gao Q, Gu Z, Hiscott J, et al: 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.
42. Larder BA, Kemp SD, Harrigan PR: Potential mechanism for sustained antiretroviral efficacy of zidovudine-3TC combination therapy. Science 1995, 269:696-699.
43. Kuritzkes D, Quinn J, Benoit S, et al.: Drug resistance, syncytium-inducing phenotype, and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) vs zidovudine (ZDV) vs ZDV plus 3TC in previously untreated patients. AIDS 1996, 10:975-981.
44. de Jong MD, Veentra J, Stilianakis N, et al.: Return to baseline value of HIV-1 RNA load during zidovudine treatment is associated with emergence of K70R mutant virus. 4th International Workshop on HIV Drug Resistance. Sardinia, July 1995 [abstract 20].
45. Mayers DL, Yerly S, Perrin L, et al.: Prevalence and clinical impact of seroconversion with zidovudine-resistant (zidovudine R) HIV-1 between 1988 and 1994. National Conference on Human Retroviruses and Related Infections. 1995 [abstract 125].