Attenzione: i dati modificati non sono ancora stati salvati. Per confermare inserimenti o cancellazioni di voci è necessario confermare con il tasto SALVA/INSERISCI in fondo alla pagina
IRIS
Background CC chemokine receptor 5 antagonists are a new class of antiretroviral agents.Methods We conducted two double- blind, placebo- controlled, phase 3 studies - Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment- Experienced Patients ( MOTIVATE) 1 and MOTIVATE 2 - with patients who had R5 human immunodeficiency virus type 1 ( HIV- 1) only. They had been treated with or had resistance to three antiretroviral- drug classes and had HIV- 1 RNA levels of more than 5000 copies per milliliter. The patients were randomly assigned to one of three antiretroviral regimens consisting of maraviroc once daily, maraviroc twice daily, or placebo, each of which included optimized background therapy ( OBT) based on treatment history and drug- resistance testing. Safety and efficacy were assessed after 48 weeks.Results A total of 1049 patients received the randomly assigned study drug; the mean baseline HIV- 1 RNA level was 72,400 copies per milliliter, and the median CD4 cell count was 169 per cubic millimeter. At 48 weeks, in both studies, the mean change in HIV- 1 RNA from baseline was greater with maraviroc than with placebo: - 1.66 and - 1.82 log(10) copies per milliliter with the once- daily and twice- daily regimens, respectively, versus - 0.80 with placebo in MOTIVATE 1, and - 1.72 and - 1.87 log(10) copies per milliliter, respectively, versus - 0.76 with placebo in MOTIVATE 2. More patients receiving maraviroc once or twice daily had HIV- 1 RNA levels of less than 50 copies per milliliter ( 42% and 47%, respectively, vs. 16% in the placebo group in MOTIVATE 1; 45% in both maraviroc groups vs. 18% in MOTIVATE 2; P< 0.001 for both comparisons in each study). The change from baseline in CD4 counts was also greater with maraviroc once or twice daily than with placebo ( increases of 113 and 122 per cubic millimeter, respectively, vs. 54 in MOTIVATE 1; increases of 122 and 128 per cubic millimeter, respectively, vs. 69 in MOTIVATE 2; P< 0.001 for both comparisons in each study). Frequencies of adverse events were similar among the groups.Conclusions Maraviroc, as compared with placebo, resulted in significantly greater suppression of HIV- 1 and greater increases in CD4 cell counts at 48 weeks in previously treated patients with R5 HIV- 1 who were receiving OBT. (ClinicalTrials. gov numbers, NCT00098306 and NCT00098722.).
Maraviroc for previously treated patients with R5 HIV-1 infection
Gulick, Roy M;Lalezari, Jacob;Goodrich, James;Clumeck, Nathan;DeJesus, Edwin;Horban, Andrzej;Nadler, Jeffrey;Clotet, Bonaventura;Karlsson, Anders;Wohlfeiler, Michael;Montana, John B;McHale, Mary;Sullivan, John;Ridgway, Caroline;Felstead, Steve;Dunne, Michael W;van der Ryst, Elna;Mayer;Howard MOTIVATE Study Teams: Jonathan Angel;Brian Conway;Kevin A Gough;Richard G Lalonde;Francois Laplante;Roger P Leblanc;Julio S G Montaner;Anita R Rachlis;Barbara Romanowski;Stuart J Rosser;Ethan Rubinstein;Stephen David Shafran;Fiona Smaill;Cecile Tremblay;Benoit Trottier;Sylvie Trottier;Christos Tsoukas;Sharon Lynn Walmsley;Alen Voskanian;Bisher Akil;Roberto Claudio Arduino;David Asmuth;George William Beatty;Stephen Lawrence Becker;Nicholaos C Bellos;Sky Robert Blue;Robert Key Bolan;John D Brand;George Ghazaros Burnazian;Alfred F Burnside;Thomas B Campbell;Rafael E Campo;Kathleen King Casey;Paul Joseph Cimoch;Calvin J Cohen;Gregg Oscar Coodley;Roberto B Corales;Edwin DeJesus;Leslie E Diaz;George L Drusano;Jerome A Ernst;Judith E Feinberg;Lawrence Edward Feldman;Steven M Fine;Jason Andrew Flamm;Stephen Eliot Follansbee;Todd Allen Fralich;Emanuel Gallant;Eliot Warren Godofsky;Gary Green;Paula Rosa Greiger-Zanlungo;Barbara Marie Gripshover;Richard K Groger;Roy Gulick;William David Hardy;Shawn K Hassler;Richard Harold Haubrich;Stephen P Hauptman;David Holden Henry;William Keith Henry;Jose Norberto Hernandez;Charles Byron Hicks;Michael Alan Horberg;Joseph G Jemsek;Allan Rowan Kelly;Clifford A Kinder;Daniel Benjamin Klein;Laura Kogelman;Jacob Paul Lalezari;Anthony LaMarca;Harry William Lampiris;Matthew Leibowitz;Jason Mark Leider;Jeffrey Lloyd Lennox;Ralph Liporace;Harold Luther Martin;Lucia M Martinez-Bejar;Claudia Martorell;Joseph P McGowan;Donna Mildvan;Steven Miles;Ronald Takeshi Mitsuyasu;Javier Osvaldo Morales-Ramirez;Anne B Morris;Karam Chucri Mounzer;Robert Anderson Myers;Jeffrey P Nadler;Daniel Pearce;Gerald Pierone;Bruce Stephen Rashbaum;Jayashree Ravishankar;Robert Ray Redfield;Richard Craig Reichman;William Jay Robbins;Stockton Edward Roberts;Jorge E Rodriguez;Michael Saag;Kunthavi Sathasivam;Paul Edward Sax;Lawrence E Schwartz;Sorana Segal-Maurer;Michael Grant Sension;Gladys E Sepulveda-Arzola;Paul Richard Skolnik;Louis Marshall Sloan;Robert P Smith;James Michael Sosman;Jack Thomas Stapleton;Roy Steigbigel;Corklin R Steinhart;Donna Elaine Sweet;Susan Swindells;Pablo Tebas;Melanie Ann Thompson;Silver Sisneros;William James Towner;Peter Gordon;Trevor N Hawkins;David Allen Wheeler;Sally Williams;Dean Wilcox;Steven Williams;Todd Stephen Wills;Michael Bruce Wohlfeiler;David Wright;Angela Xavier;Bienvenido Gamulo Yangco;Barry Stephen Zingman;Carmen D Zorrilla;Anthony M Allworth;Mark T Bloch;Neil J Bodsworth;John Chuah;David Cooper;Nicholas Doong;Dominic Dwyer;Julian Gold;Jennifer Frances Hoy;Richard J Moore;Norman J Roth;Cassy Workman;Nathan Clumeck;Patricia Dellot;Jean Christophe Goffard;Michel Moutschen;Bernard C Vandercam;Dirk Vogelaers;Danielle Rouleau;Michele Bentata;Laurent Cotte;Jean-Francois Delfraissy;Jacques Durant;Pierre-Marie Girard;Laurent Hocqueloux;Roland Landman;Alain Lafeuillade;Isabelle Poizot Martin;Jean-Michel Molina;Gilles Pialoux;Christophe Piketty;Francois Raffi;Jacques Reynes;Renaud Verdon;Keikawus Arasteh;Johannes Richard Bogner;Norbert H Brockmeyer;Stefan Esser;Gerd Fätkenheuer;Frank-Detlef Goebel;Thomas Harrer;Peter Kern;Heribert Knechten;Jan van Lunzen;Markus Mueller;Antonius Mutz;Mark Oette;Andreas Plettenberg;Juergen Rockstroh;Jorg-Andres Rump;Reinhold E Schmidt;Lothar Schneider;Dieter Schuster;Schlomo Staszewski;Hans-Juergen Stellbrink;Andreas Trein;Lutwinus Weitner;Fernando Aiuti;Dante Bassetti;Antonio Di Biagio;Pietro Caramello;Giampiero Carosi;Roberto Esposito;Adriano Lazzarin;Francesco Leoncini;Paolo Emilio Manconi;Francesco Mazzotta;Francesco Montella;Enzo Raise;Vicenzo Vullo;Ilja Mohandas Hoepelman;Rosalinde Maria Perenboom;J M Prins;Clemens Richter;Marchina Elisabeth Van der Ende;Marek Beniowski;Anna Boron-Kaczmarska;Robert Flisiak;Waldemar Halota;Andrzej Horban;Tomasz Mach;Tomasz Smiatacz;Fernando Lozano de Leon;Pompeyo Viciana Fernandez;Rafael Rubio Garcia;Jose Josep Gatell Artigas;Juan Julian Gonzalez Garcia;Felix Gutierrez;Juan Gonzalez Lahoz;Jose Iribarren Loyarte;Santiago Moreno;Federico Pulido Ortega;Pere Domingo Pedrol;Antonio Rivero;Bonaventura Clotet;Cristina Sarria;Magnus Gisslen;Leo Flamholc;Anders Karlsson;Manuel Battegay;Enos Bernasconi;Matthias Cavassini;Henning Drechsler;Bernard Hirschel;Milos Opravil;Pietro Vernazza;Philippa Jane Easterbrook;Martin Fisher;Philip Hay;Margaret A Johnson;Clifford L Leen;Mark R Nelson;Edmund Ong;Jonathan N Weber;David J White;Edmund Wilkins;Martin Wiselka;Ana Maria Alvarez-Jacinto;Diana Antoniskis;Barbara A Atkinson;Daniel S Berger;Gary Blick;Robert Owen Brenna;Jeffrey Howard Burack;L W Preston Church;Patrick G Clay;Paul Peniston Cook;Catherine Maria Creticos;Patrick William Daly;Getachew Feleke;Thomas Mc Donald File;Jeffrey Eliot Galpin;Stephen Lloyd Green;Frances Fae Haas;Barbara J Hanna;Chiu-Bin Hsiao;Ricky K Hsu;Robert S Jones;Peter Kadlecik;Robert Charles Kalayjian;Robert H Keller;Shubha Kerkar;Janak Koirala;Leon Liang-Yu Lai;Sujata Lalla-Reddy;Rodger David Macarthur;Gregory John Malanoski;Norman Peter Markowitz;Patrick L McLeroth;Alexander A McMeeking;Goran Miljkovic;John Buscemi Montana;Daniel Edward Nixon;Dorece G Norris;Jesse Pullen Penico;Leonel Perez-Limonte;Lynette H Posorske;David James Prelutsky;James Riddell;Barry Michael Rodwick;Peter Jerome Ruane;James Sampson;Steven Santiago;Amy Seinfeld;Victoria Lee Sharp;Zaher Shebib;Mark Leslie Tanner;Joseph G Timpone;Barbara H Wade;Frances Wallach;Winkler Weinberg;Christine Zurawski
2008-01-01
Abstract
Background CC chemokine receptor 5 antagonists are a new class of antiretroviral agents.Methods We conducted two double- blind, placebo- controlled, phase 3 studies - Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment- Experienced Patients ( MOTIVATE) 1 and MOTIVATE 2 - with patients who had R5 human immunodeficiency virus type 1 ( HIV- 1) only. They had been treated with or had resistance to three antiretroviral- drug classes and had HIV- 1 RNA levels of more than 5000 copies per milliliter. The patients were randomly assigned to one of three antiretroviral regimens consisting of maraviroc once daily, maraviroc twice daily, or placebo, each of which included optimized background therapy ( OBT) based on treatment history and drug- resistance testing. Safety and efficacy were assessed after 48 weeks.Results A total of 1049 patients received the randomly assigned study drug; the mean baseline HIV- 1 RNA level was 72,400 copies per milliliter, and the median CD4 cell count was 169 per cubic millimeter. At 48 weeks, in both studies, the mean change in HIV- 1 RNA from baseline was greater with maraviroc than with placebo: - 1.66 and - 1.82 log(10) copies per milliliter with the once- daily and twice- daily regimens, respectively, versus - 0.80 with placebo in MOTIVATE 1, and - 1.72 and - 1.87 log(10) copies per milliliter, respectively, versus - 0.76 with placebo in MOTIVATE 2. More patients receiving maraviroc once or twice daily had HIV- 1 RNA levels of less than 50 copies per milliliter ( 42% and 47%, respectively, vs. 16% in the placebo group in MOTIVATE 1; 45% in both maraviroc groups vs. 18% in MOTIVATE 2; P< 0.001 for both comparisons in each study). The change from baseline in CD4 counts was also greater with maraviroc once or twice daily than with placebo ( increases of 113 and 122 per cubic millimeter, respectively, vs. 54 in MOTIVATE 1; increases of 122 and 128 per cubic millimeter, respectively, vs. 69 in MOTIVATE 2; P< 0.001 for both comparisons in each study). Frequencies of adverse events were similar among the groups.Conclusions Maraviroc, as compared with placebo, resulted in significantly greater suppression of HIV- 1 and greater increases in CD4 cell counts at 48 weeks in previously treated patients with R5 HIV- 1 who were receiving OBT. (ClinicalTrials. gov numbers, NCT00098306 and NCT00098722.).
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11567/1135415
Attenzione
Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo
Citazioni
282
663
603
social impact
Conferma cancellazione
Sei sicuro che questo prodotto debba essere cancellato?
simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.