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Titolo:
A randomized, double-blind study of triple nucleoside therapy of abacavir,lamivudine, and zidovudine versus lamivudine and zidovudine in previously treated human immunodeficiency virus type 1-infected children
Autore:
Saez-Llorens, X; Nelson, RP; Emmanuel, P; Wiznia, A; Mitchell, C; Church, JA; Sleasman, J; Van Dyke, R; Richardson, CG; Cutrell, A; Spreen, W; Hetherington, S;
Indirizzi:
Hosp Nino, Serv Infectol, Panama City, Panama Hosp Nino Panama City Panama p Nino, Serv Infectol, Panama City, Panama Indiana Univ, Dept Hematol & Oncol, Indianapolis, IN 46204 USA Indiana Univ Indianapolis IN USA 46204 Oncol, Indianapolis, IN 46204 USA Univ S Florida, Coll Med, Tampa, FL USA Univ S Florida Tampa FL USAUniv S Florida, Coll Med, Tampa, FL USA Jacobi Med Ctr, Dept Pediat, Bronx, NY USA Jacobi Med Ctr Bronx NY USAJacobi Med Ctr, Dept Pediat, Bronx, NY USA Univ Miami, Sch Med, Div Pediat Infect Dis, Miami, FL USA Univ Miami Miami FL USA i, Sch Med, Div Pediat Infect Dis, Miami, FL USA Childrens Hosp Los Angeles, Div Clin Allergy & Immunol, Los Angeles, CA USA Childrens Hosp Los Angeles Los Angeles CA USA munol, Los Angeles, CA USA Univ Florida, Div Infect Dis & Immunol, Gainesville, FL USA Univ Florida Gainesville FL USA nfect Dis & Immunol, Gainesville, FL USA Tulane Univ, Sch Med, Dept Pediat, New Orleans, LA 70112 USA Tulane Univ New Orleans LA USA 70112 pt Pediat, New Orleans, LA 70112 USA Glaxo Wellcome Inc, Res Triangle Pk, NC 27709 USA Glaxo Wellcome Inc Res Triangle Pk NC USA 27709 Triangle Pk, NC 27709 USA
Titolo Testata:
PEDIATRICS
fascicolo: 1, volume: 107, anno: 2001,
pagine: NIL_25 - NIL_35
SICI:
0031-4005(200101)107:1<NIL_25:ARDSOT>2.0.ZU;2-O
Fonte:
ISI
Lingua:
ENG
Soggetto:
PROTEASE INHIBITOR INDINAVIR; COMBINATION THERAPY; PHASE I/II; INFECTED INFANTS; HIV-1 INFECTION; STAVUDINE D4T; DIDANOSINE; 1592U89; DISEASE; SAFETY;
Keywords:
human immunodeficiency virus type 1; abacavir; lamivudine; zidovudine; viral ribonucleic acid; CD4; antiretroviral therapy; pediatric;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
38
Recensione:
Indirizzi per estratti:
Indirizzo: Saez-Llorens, X Hosp Nino, Serv Infectol, Ave Balboa & Calle 34,Zona 5-4087, Panama City, Panama Hosp Nino Ave Balboa & Calle 34,Zona 5-4087 Panama City Panama
Citazione:
X. Saez-Llorens et al., "A randomized, double-blind study of triple nucleoside therapy of abacavir,lamivudine, and zidovudine versus lamivudine and zidovudine in previously treated human immunodeficiency virus type 1-infected children", PEDIATRICS, 107(1), 2001, pp. NIL_25-NIL_35

Abstract

Objectives. Abacavir (ABC) is a potent inhibitor of human immunodeficiencyvirus type 1 (HIV-1) reverse transcriptase. We compared the efficacy, safety, and tolerability of combination therapy with ABC, lamivudine (3TC), andzidovudine (ZDV) versus 3TC and ZDV in antiretroviral experienced HIV-1-infected children over 48 weeks. Methods. Two hundred five HIV-1-infected children who had received previous antiretroviral therapy and had CD4(+) cell counts greater than or equal to 100 cells/mm(3) were stratified by age and by previous treatment. Participants were randomly assigned to receive ABC (8 mg/kg twice daily [BID]) plus 3TC (4 mg/kg BID) and ZDV (180 mg/m(2) BID; ABC/3TC/ZDV group) or ABC placebo plus 3TC (4 mg/kg BID) and ZDV (180 mg/m(2); 3TC/ZDV group). Participants who met a protocol-defined switch criteria (plasma HIV-1 RNA >0.5 log(10) copies/mL above baseline at week 8 or >10 000 copies/mL after week 16) had the option to switch to open-label ABC plus any antiretroviral combination or continue randomized therapy or withdraw from the study. Results. The Kaplan-Meier estimates (95% confidence interval) of the proportion of participants who maintained HIV-1 RNA levels <10 000 copies/mL for48 weeks or more was significantly better in the ABC/3TC/ZDV group compared with the 3TC/ZDV group: 33% (23%-42%) versus 21% (13%-29%). At week 48, the proportions of participants with HIV-1 RNA <10 000 copies/mL were 36% versus 26% for the ABC/3TC/ZDV and 3TC/ZDV groups, respectively, by intent-to-treat analysis. For the subgroup of participants with baseline HIV-1 RNA >10 000 copies/mL, a significantly higher proportion of participants in the ABC/3TC/ZDV group had HIV-1 RNA <10 000 copies/mL compared with the 3TC/ZDVgroup (29% vs 12%) but no difference was observed in the subgroup of participants with baseline HIV-1 RNA <10 000 copies/mL (78% vs 72%). The median changes from baseline in CD4(+) cell counts were greater in the ABC/3TC/ZDVgroup than in the 3TC/ZDV group. Few participants (3%) experienced abacavir-related hypersensitivity reaction. Conclusions. ABC, in combination with 3TC and ZDV, provides additional antiretroviral activity over 48 weeks, compared with combination therapy with 3TC and ZDV in antiretroviral experienced HIV-1-infected children. ABC was safe and generally well-tolerated and should be considered an active component of combination antiretroviral therapy in this pediatric population.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/04/20 alle ore 20:31:43