Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
INSIGHTS FROM MONITORING THE CPCRA DIDANOSINE ZALCITABINE TRIAL
Autore:
FLEMING TR; NEATON JD; GOLDMAN A; DEMETS DL; LAUNER C; KORVICK J; ABRAMS D; BEERS D; LOVELESS K; MARTINEZ N; MESARD CA; REVES RR; ROUFF JA; KLEIN T; MCDONALD R; SLOTTEN R; BROSGART C; DREW L; FESSEL J; HUDSON R; LOPEZ C; THOMPSON S; KUMI JO; MASTROPOLAK D; SARAVOLATZ LD; KERKERING TM; HIGGINSON RA; GERNON L; BAR M; MENDEZ D; ERNST J; SCOTT J; FINLEY B; WARD D; WISNIEWSKI T; BRANDON W; WALTER J; CALHOUN C; EBRIGHT JR; SCHUMAN P; BINCSIK A; SWANSON K; WINSLOW D; SHERIDAN A; TAYLOR V; PEREZ G; ELSADR W; GUITY C; JULEAU J; SALVATI S; DOWLING C; SALVADOR GI; BURNS AJ; LAM SH; CHILDRESS JF; DEETS DL; FLEMING TR; MEYER KH; POLLARD RB; OFALLON JR; RAHAL JJ; WALTERS L; WHITNEYWILLIAMS P; WHITLEY RJ;
Indirizzi:
UNIV WASHINGTON,DEPT BIOSTAT,SC-32 SEATTLE WA 98195 UNIV MINNESOTA MINNEAPOLIS MN 55455 UNIV WISCONSIN MADISON WI 00000 NIAID BETHESDA MD 20892 UNIV CALIF SAN FRANCISCO SAN FRANCISCO CA 94143
Titolo Testata:
Journal of acquired immune deficiency syndromes and human retrovirology
, volume: 10, anno: 1995, supplemento:, 2
pagine: 9 - 18
SICI:
1077-9450(1995)10:<9:IFMTCD>2.0.ZU;2-R
Fonte:
ISI
Lingua:
ENG
Soggetto:
CLINICAL-TRIALS; HIV; THERAPY;
Keywords:
EQUIVALENCE TRIALS; DATA AND SAFETY MONITORING BOARDS; SURROGATE END POINTS; AIDS PROGRESSION; COVARIATES;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
20
Recensione:
Indirizzi per estratti:
Citazione:
T.R. Fleming et al., "INSIGHTS FROM MONITORING THE CPCRA DIDANOSINE ZALCITABINE TRIAL", Journal of acquired immune deficiency syndromes and human retrovirology, 10, 1995, pp. 9-18

Abstract

The design, conduct, and analysis of clinical trials that evaluate the safety and efficacy of treatment interventions in patients with HIV infection provide many scientific challenges. A recently completed randomized trial of didanosine (ddI) and zalcitabine (ddC), sponsored by the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), is an especially valuable resource for illustrating these challenging issues and for providing insights into how they might be properly addressed. Establishing equivalence of treatment effects on clinical efficacy end points is illustrated through the use of the confidence interval approach. The striking changes in treatment efficacy results that occurred during the course of the CPCRA trial provide important insights into how a data and safety monitoring board can reduce the risk of inappropriate early study termination. The trial also provides valuable insights into how treatment effects should be assessed, revealinginconsistencies between effects on the CD4 surrogate end point and effects on primary clinical efficacy end points and showing the incompleteness of the standardly employed definition of AIDS progression. Finally, the results of this ddI/ddC trial are used to examine the role ofcovariate adjustment.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/11/20 alle ore 08:49:36