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Titolo:
ACTG (AIDS Clinical Trials Group) 384: A strategy trial comparing consecutive treatments for HIV-1
Autore:
Smeaton, LM; DeGruttola, V; Robbins, GK; Shafer, RW;
Indirizzi:
Harvard Univ, Sch Publ Hlth, Ctr Biostat AIDS Res, Boston, MA 02115 USA Harvard Univ Boston MA USA 02115 r Biostat AIDS Res, Boston, MA 02115 USA Massachusetts Gen Hosp, Boston, MA 02114 USA Massachusetts Gen Hosp Boston MA USA 02114 Gen Hosp, Boston, MA 02114 USA Stanford Univ, Med Ctr, Stanford, CA 94305 USA Stanford Univ Stanford CA USA 94305 Univ, Med Ctr, Stanford, CA 94305 USA
Titolo Testata:
CONTROLLED CLINICAL TRIALS
fascicolo: 2, volume: 22, anno: 2001,
pagine: 142 - 159
SICI:
0197-2456(200104)22:2<142:A(CTG3>2.0.ZU;2-D
Fonte:
ISI
Lingua:
ENG
Soggetto:
IMMUNODEFICIENCY-VIRUS INFECTION; PROTEASE INHIBITORS; ANTIRETROVIRAL THERAPY; DRUG-RESISTANCE; PLUS INDINAVIR; DOUBLE-BLIND; ZIDOVUDINE; LAMIVUDINE; DIDANOSINE; MUTATIONS;
Keywords:
clinical trials design; phase III study; randomized; controlled; multicenter; double-blind; trial; AIDS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
30
Recensione:
Indirizzi per estratti:
Indirizzo: Smeaton, LM Harvard Univ, Sch Publ Hlth, Ctr Biostat AIDS Res, 651 Huntington Ave,Francois-Xavier Bagnound Bldg, Boston, MA 02115 USA Harvard Univ 651 Huntington Ave,Francois-Xavier Bagnound Bldg Boston MA USA 02115
Citazione:
L.M. Smeaton et al., "ACTG (AIDS Clinical Trials Group) 384: A strategy trial comparing consecutive treatments for HIV-1", CONTR CL TR, 22(2), 2001, pp. 142-159

Abstract

ACTG (AIDS Clinical Trials Group) 384 is designed to evaluate different strategies for antiretroviral treatment in HIV-1-infected individuals with noprevious exposure to antiretroviral treatment. The study is a randomized, partially double-blinded, controlled trial with 980 subjects at 81 centers in the United States and Italy. The study has a factorial design that addresses the following scientific questions: (1) Does the best initial choice of therapy include both a protease inhibitor (PI) and non-nucleoside reversetranscriptase inhibitor (NNRTI) in a four-drug combination with nucleosideanalogue (NRTI) drugs, or should these agents be used sequentially in three-drug combinations?; (2) Which sequence is best in a three-drug regimen-PIfollowed by NNRTI or NNRTI followed by PI ?; (3) Which is the best sequence of dual NRTI combinations-zidovudine plus lamivudine followed by didanosine plus stavudine, or the converse? Subjects in the three-drug combination arms are offered a salvage regimen after failure of their second regimen; subjects in the four-drug combination arm are offered a salvage regimen after failure of their first regimen. The primary endpoint of the study is the time until salvage; secondary endpoints include time to virological failureand time to toxicity related discontinuation of therapy. A Division of AIDS Data and Safety Monitoring Board will review the trial for safety and efficacy. (C) Elsevier Science Inc. 2001.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/04/20 alle ore 11:24:23