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N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.

Maraviroc for previously treated patients with R5 HIV-1 infection.

Collaborators (301)

Angel J, Conway B, Gough KA, Lalonde RG, Laplante F, Leblanc RP, Montaner JS, Rachlis AR, Romanowski B, Rosser SJ, Rubinstein E, Shafran SD, Smaill F, Tremblay C, Trottier B, Trottier S, Tsoukas C, Walmsley SL, Voskanian A, Akil B, Arduino RC, Asmuth D, Beatty GW, Becker SL, Bellos NC, Blue SR, Bolan RK, Brand JD, Burnazian GG, Burnside AF, Campbell TB, Campo RE, Casey KK, Cimoch PJ, Cohen CJ, Coodley GO, Corales RB, DeJesus E, Diaz LE, Drusano GL, Ernst JA, Feinberg JE, Feldman LE, Fine SM, Flamm JA, Follansbee SE, Fralich TA, Gallant E, Godofsky EW, Green G, Greiger-Zanlungo PR, Gripshover BM, Groger RK, Gulick R, Hardy WD, Hassler SK, Haubrich RH, Hauptman SP, Henry DH, Henry WK, Hernandez JN, Hicks CB, Horberg MA, Jemsek JG, Kelly AR, Kinder CA, Klein DB, Kogelman L, Lalezari JP, LaMarca A, Lampiris HW, Leibowitz M, Leider JM, Lennox JL, Liporace R, Martin HL, Martinez-Bejar LM, Martorell C, McGowan JP, Mildvan D, Miles S, Mitsuyasu RT, Morales-Ramirez JO, Morris AB, Mounzer KC, Myers RA, Nadler JP, Pearce D, Pierone G, Rashbaum BS, Ravishankar J, Redfield RR, Reichman RC, Robbins WJ, Roberts SE, Rodriguez JE, Saag M, Sathasivam K, Sax PE, Schwartz LE, Segal-Maurer S, Sension MG, Sepulveda-Arzola GE, Skolnik PR, Sloan LM, Smith RP, Sosman JM, Stapleton JT, Steigbigel R, Steinhart CR, Sweet DE, Swindells S, Tebas P, Thompson MA, Sisneros S, Towner WJ, Gordon P, Hawkins TN, Wheeler DA, Williams S, Wilcox D, Williams S, Wills TS, Wohlfeiler MB, Wright D, Xavier A, Yangco BG, Zingman BS, Zorrilla CD, Allworth AM, Bloch MT, Bodsworth NJ, Chuah J, Cooper D, Doong N, Dwyer D, Gold J, Hoy JF, Moore RJ, Roth NJ, Workman C, Clumeck N, Dellot P, Goffard JC, Moutschen M, Vandercam BC, Vogelaers D, Rouleau D, Bentata M, Cotte L, Delfraissy JF, Durant J, Girard PM, Hocqueloux L, Landman R, Lafeuillade A, Martin IP, Molina JM, Pialoux G, Piketty C, Raffi F, Reynes J, Verdon R, Arasteh K, Bogner JR, Brockmeyer NH, Esser S, Fätkenheuer G, Goebel FD, Harrer T, Kern P, Knechten H, van Lunzen J, Mueller M, Mutz A, Oette M, Plettenberg A, Rockstroh J, Rump JA, Schmidt RE, Schneider L, Schuster D, Staszewski S, Stellbrink HJ, Trein A, Weitner L, Aiuti F, Bassetti D, Di Biagio A, Caramello P, Carosi G, Esposito R, Lazzarin A, Leoncini F, Manconi PE, Mazzotta F, Montella F, Raise E, Vullo V, Hoepelman IM, Perenboom RM, Prins JM, Richter C, Van der Ende ME, Beniowski M, Boron-Kaczmarska A, Flisiak R, Halota W, Horban A, Mach T, Smiatacz T, Lozano de Leon F, Viciana Fernandez P, Rubio Garcia R, Gatell Artigas JJ, Gonzalez Garcia JJ, Gutierrez F, Gonzalez Lahoz J, Iribarren Loyarte J, Moreno S, Pulido Ortega F, Domingo Pedrol P, Rivero A, Clotet B, Sarria C, Gisslen M, Flamholc L, Karlsson A, Battegay M, Bernasconi E, Cavassini M, Drechsler H, Hirschel B, Opravil M, Vernazza P, Easterbrook PJ, Fisher M, Hay P, Johnson MA, Leen CL, Nelson MR, Ong E, Weber JN, White DJ, Wilkins E, Wiselka M, Alvarez-Jacinto AM, Antoniskis D, Atkinson BA, Berger DS, Blick G, Brenna RO, Burack JH, Church LW, Clay PG, Cook PP, Creticos CM, Daly PW, Feleke G, File TM, Galpin JE, Green SL, Haas FF, Hanna BJ, Hsiao CB, Hsu RK, Jones RS, Kadlecik P, Kalayjian RC, Keller RH, Kerkar S, Koirala J, Lai LL, Lalla-Reddy S, Macarthur RD, Malanoski GJ, Markowitz NP, McLeroth PL, McMeeking AA, Miljkovic G, Montana JB, Nixon DE, Norris DG, Penico JP, Perez-Limonte L, Posorske LH, Prelutsky DJ, Riddell J, Rodwick BM, Ruane PJ, Sampson J, Santiago S, Seinfeld A, Sharp VL, Shebib Z, Tanner ML, Timpone JG, Wade BH, Wallach F, Weinberg W, Zurawski C.

Author information

  • 1Weill-Cornell Medical College, New York, NY 10065, USA. rgulick@med.cornell.edu

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.)

2008 Massachusetts Medical Society

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PMID:
18832244
[PubMed - indexed for MEDLINE]
PMCID:
PMC3078519
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