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Titolo:
A DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABACAVIR ALONE OR IN COMBINATION WITH ZIDOVUDINE AND LAMIVUDINE IN ANTIRETROVIRAL TREATMENT NAIVE SUBJECTS
Autore:
STASZEWSKI S; KATLAMA C; HARRER T; MASSIP P; YENI P; CUTRELL A; TORTELL SM; HARRIGAN RP; STEEL H; LANIER RE; PEARCE G;
Indirizzi:
UNIV FRANKFURT KLINIKUM D-6000 FRANKFURT GERMANY GRP HOSP PITIE SALPETRIERE F-75634 PARIS FRANCE UNIV ERLANGEN NURNBERG,DEPT MED 3 D-8520 ERLANGEN GERMANY HOP PUPAN TOULOUSE FRANCE HOP BICHAT CLAUDE BERNARD F-75877 PARIS 18 FRANCE GLAXO WELLCOME INC RES TRIANGLE PK NC 27709 GLAXO WELLCOME RES & DEV LTD GREENFORD MIDDX ENGLAND
Titolo Testata:
AIDS
fascicolo: 16, volume: 12, anno: 1998,
pagine: 197 - 202
SICI:
0269-9370(1998)12:16<197:ADSTET>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Keywords:
ANTIRETROVIRAL THERAPY; COMBINATION THERAPY; VIRAL LOAD; ABACAVIR; 1592U89; ZIDOVUDINE; LAMIVUDINE;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
8
Recensione:
Indirizzi per estratti:
Citazione:
S. Staszewski et al., "A DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABACAVIR ALONE OR IN COMBINATION WITH ZIDOVUDINE AND LAMIVUDINE IN ANTIRETROVIRAL TREATMENT NAIVE SUBJECTS", AIDS, 12(16), 1998, pp. 197-202

Abstract

Objective: To compare antiretroviral efficacy, safety and tolerance of three dosing regimens of the novel nucleoside reverse transcriptase inhibitor, abacavir (1592U89) over 23 weeks and its efficacy in open-label combination with zidovudine and lamivudine. Design: Sixty HIV-1-infected antiretroviral therapy naive subjects (entry criteria; CD4+ cell count greater than or equal to 100 cells/mm(3), plasma HIV-1 RNA greater than or equal to 30 000 copies/ml), randomized into 20 subjects per cohort received 100, 300 or 600 mg abacavir twice daily. Subjects successfully completing 24 weeks' randomized therapy could switch to open label therapy abacavir, zidovudine, lamivudine at 300, 300 and 150mg twice daily, respectively) for a further 24 weeks of study, as could subjects meeting one or more switch criteria. Methods: Subjects were assessed for antiretroviral activity by measuring changes in plasma HIV-1 RNA load and CD4+ cell counts. Evaluation of safety and tolerance was based on clinical adverse events and laboratory analyses. Results: At week 4, subjects receiving 300 or 600 mg abacavir twice daily had greater reductions in plasma HIV-1 RNA (median changes -1.55 and -1.61 log(10) copies/ml, respectively); differences (P = 0.007 and P lessthan or equal to 0.001, respectively) than subjects receiving 100 mg abacavir twice daily (median change, -0.63 log(10) copies/ml). Differences between the 300 and 600 mg twice daily groups were not clinicallyor statistically significant. At 24 weeks, analysis showed a median change in plasma HIV-1 RNA of -0.70 and -1.30 log(10) copies/ml in the 300 and 600 mg twice daily groups, respectively. During the open labelphase In which zidovudine/lamivudine was added to 300 mp abacavir twice daily, a further median reduction in plasma HIV-1 RNA of 1.74 log(10) copies/ml was seen. At 48 weeks pooled data from all abacavir-treated subjects showed a sustained reduction in plasma HIV-1 RNA of 2.8 log(10) copies/ml; 65% and 43% of subjects had less than or equal to 400and less than or equal to 50 HIV-1 RNA copies/ml, respectively, and afurther median increase of 111 CD4+ cells/mm(3) were seen. Abacavir was generally well tolerated with few clinically significant adverse events. Two subjects (3.3%) developed hypersensitivity reactions to abacavir. There were no differences between the groups with regard tu serious adverse events. Conclusions: In terms of antiretroviral therapy naive subjects;, treatment with 300 or 600 mg abacavir twice daily was statistically superior to a 100 mg twice daily dose at 4 weeks. Combinations therapy containing abacavir-zidovudine-lamivudine was a highly effective antiretroviral regimen, resulting in substantial reductions in plasma HIV-1 RNA which may be comparable to combinations containing protease inhibitors. Abacavir was generally tolerated. (C) 1998 Lippincott Williams & Wilkins

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 03:33:09