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N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.

Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection.

Collaborators (300)

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, 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

  • 1Universitätsklinik Köln, Cologne, Germany. g.faetkenheuer@uni-koeln.de

Abstract

BACKGROUND:

We conducted subanalyses of the combined results of the Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients (MOTIVATE) 1 and MOTIVATE 2 studies to better characterize the efficacy and safety of maraviroc in key subgroups of patients.

METHODS:

We analyzed pooled data from week 48 from the two studies according to sex, race or ethnic group, clade, CC chemokine receptor 5 (CCR5) delta32 genotype, viral load at the time of screening, the use or nonuse of enfuvirtide in optimized background therapy (OBT), the baseline CD4 cell count, the number of active antiretroviral drugs coadministered, the first use of selected background agents, and tropism at baseline. Changes in viral tropism and the CD4 count at treatment failure were evaluated. Data on aminotransferase levels in patients coinfected with hepatitis B virus (HBV) or hepatitis C virus (HCV) were also analyzed.

RESULTS:

A treatment benefit of maraviroc plus OBT over placebo plus OBT was shown in all subgroups, including patients with a low CD4 cell count at baseline, those with a high viral load at screening, and those who had not received active agents in OBT. Analyses of the virologic response according to the first use of selected background drugs showed the additional benefit of adding a potent new drug to maraviroc at the initiation of maraviroc therapy. More patients in whom maraviroc failed had a virus binding to the CXC chemokine receptor 4 (CXCR4) at failure, but there was no evidence of a decrease in the CD4 cell count at failure in such patients as compared with those in whom placebo failed. Subanalyses involving patients coinfected with HBV or HCV revealed no evidence of excess hepatotoxic effects as compared with baseline.

CONCLUSIONS:

Subanalyses of pooled data from week 48 indicate that maraviroc provides a valuable treatment option for a wide spectrum of patients with R5 HIV-1 infection who have been treated previously. (ClinicalTrials.gov numbers, NCT00098306 and NCT00098722.)

2008 Massachusetts Medical Society

Comment in

PMID:
18832245
[PubMed - indexed for MEDLINE]
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