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Items: 39

1.

No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV-1-Infected Subjects.

Vourvahis M, McFadyen L, Nepal S, Valluri SR, Fang A, Fate GD, Wood LS, Marshall JC, Chan PLS, Nedderman A, Haynes J, Savage ME, Clark A, Smith KY, Heera J.

J Clin Pharmacol. 2019 Jan;59(1):139-152. doi: 10.1002/jcph.1306. Epub 2018 Sep 7.

PMID:
30192390
2.

Pharmacokinetics, Safety and Efficacy of Maraviroc in Treatment-experienced Pediatric Patients Infected With CCR5-Tropic HIV-1.

Giaquinto C, Mawela MP, Chokephaibulkit K, Negra MD, Mitha IH, Fourie J, Fang A, van der Ryst E, Valluri SR, Vourvahis M, Zhang-Roper RY, Craig C, McFadyen L, Clark A, Heera J.

Pediatr Infect Dis J. 2018 May;37(5):459-465. doi: 10.1097/INF.0000000000001808.

3.

Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial.

Rockstroh JK, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J.

Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.

PMID:
27924779
4.

Once-daily maraviroc versus tenofovir/emtricitabine each combined with darunavir/ritonavir for initial HIV-1 treatment.

Stellbrink HJ, Le Fevre E, Carr A, Saag MS, Mukwaya G, Nozza S, Valluri SR, Vourvahis M, Rinehart AR, McFadyen L, Fichtenbaum C, Clark A, Craig C, Fang AF, Heera J.

AIDS. 2016 May 15;30(8):1229-38. doi: 10.1097/QAD.0000000000001058.

5.

Corrigendum. Hepatic Safety in Subjects With HIV-1 and Hepatitis C and/or B Virus: A Randomised, Double-Blind Study of Maraviroc vs Placebo in Combination With Antiretroviral Agents.

Rockstroch JK, Soriano V, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA.

HIV Clin Trials. 2015 Nov;16(6):236-7. doi: 10.1080/15284336.2015.1124625. No abstract available.

PMID:
26777796
6.

Development of maraviroc, a CCR5 antagonist for treatment of HIV, using a novel tropism assay.

van der Ryst E, Heera J, Demarest J, Knirsch C.

Ann N Y Acad Sci. 2015 Jun;1346(1):7-17. doi: 10.1111/nyas.12777. Epub 2015 May 11.

PMID:
25962411
7.

Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents.

Rockstroh JK, Soriano V, Plonski F, Bansal M, Fätkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA.

HIV Clin Trials. 2015 Mar-Apr;16(2):72-80. doi: 10.1179/1528433614Z.0000000011. Erratum in: HIV Clin Trials. 2015 Nov;16(6):236-8.

8.

Clinical relevance of CYP3A5 genotype on maraviroc exposures.

Vourvahis M, McFadyen L, Heera J, Clark A.

Drug Metab Dispos. 2015 May;43(5):771-2. doi: 10.1124/dmd.115.063321. No abstract available.

9.

The maraviroc expanded access program - safety and efficacy data from an open-label study.

Lazzarin A, Reynes J, Molina JM, Valluri S, Mukwaya G, Heera J, Craig C, van der Ryst E, Sierra-Madero JG.

HIV Clin Trials. 2015 Jan-Feb;16(1):10-21. doi: 10.1179/1528433614Z.0000000002. Epub 2015 Jan 23.

PMID:
25777185
10.

First prospective comparison of genotypic vs phenotypic tropism assays in predicting virologic responses to Maraviroc (MVC) in a phase 3 study: MODERN.

Heera J, Valluri S, Craig C, Fang A, Thomas N, Meyer RD, Demarest J.

J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19519. doi: 10.7448/IAS.17.4.19519. eCollection 2014.

11.

Single-dose pharmacokinetics, safety, and tolerability of modified-release formulations of lersivirine in healthy subjects.

Vourvahis M, Wang R, Mendes da Costa L, Wang C, Weatherley B, Mukwaya G, Tawadrous M, Heera J.

Clin Pharmacol Drug Dev. 2014 Nov;3(6):472-6. doi: 10.1002/cpdd.117. Epub 2014 May 26. No abstract available.

PMID:
27129121
12.

Efficacy and safety of lersivirine versus etravirine for the treatment of HIV-1 infection in patients with prior non-nucleoside reverse transcriptase inhibitor (NNRTI) use and evidence of NNRTI resistance: a randomized phase 2B trial.

DeJesus E, Fätkenheuer G, Orrell C, Wang C, Jones J, Craig C, Tawadrous M, Heera J.

HIV Clin Trials. 2014 Sep-Oct;15(5):209-17. doi: 10.1310/hct1505-209.

PMID:
25350959
13.

Efficacy and safety of maraviroc vs. efavirenz in treatment-naive patients with HIV-1: 5-year findings.

Cooper DA, Heera J, Ive P, Botes M, Dejesus E, Burnside R, Clumeck N, Walmsley S, Lazzarin A, Mukwaya G, Saag M, van Der Ryst E.

AIDS. 2014 Mar 13;28(5):717-25. doi: 10.1097/QAD.0000000000000131.

14.

The effect of maraviroc on the pharmacokinetics of digoxin in healthy volunteers.

Vourvahis M, Fang J, Choo HW, Heera J.

Clin Pharmacol Drug Dev. 2014 May;3(3):202-6. doi: 10.1002/cpdd.91. Epub 2014 Feb 6. No abstract available.

PMID:
27128610
15.

Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients.

Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR.

J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.

16.

The effects of boceprevir and telaprevir on the pharmacokinetics of maraviroc: an open-label, fixed-sequence study in healthy volunteers.

Vourvahis M, Plotka A, Kantaridis C, Fang A, Heera J.

J Acquir Immune Defic Syndr. 2014 Apr 15;65(5):564-70. doi: 10.1097/QAI.0000000000000090.

17.

Pharmacokinetic interaction between maraviroc and fosamprenavir-ritonavir: an open-label, fixed-sequence study in healthy subjects.

Vourvahis M, Plotka A, Mendes da Costa L, Fang A, Heera J.

Antimicrob Agents Chemother. 2013 Dec;57(12):6158-64. doi: 10.1128/AAC.01098-13. Epub 2013 Sep 30.

18.

Genotypic analysis of the V3 region of HIV from virologic nonresponders to maraviroc-containing regimens reveals distinct patterns of failure.

Swenson LC, Chui CK, Brumme CJ, Chan D, Woods CK, Mo T, Dong W, Chapman D, Lewis M, Demarest JF, James I, Portsmouth S, Goodrich J, Heera J, Valdez H, Harrigan PR.

Antimicrob Agents Chemother. 2013 Dec;57(12):6122-30. doi: 10.1128/AAC.01534-13. Epub 2013 Sep 30.

19.

Pharmacokinetics, safety, and tolerability of maraviroc in HIV-negative subjects with impaired renal function.

Vourvahis M, Fang J, Checchio T, Milton A, Weatherley B, McFadyen L, Heera J.

HIV Clin Trials. 2013 May-Jun;14(3):99-109. doi: 10.1310/hct1403-99.

PMID:
23835512
20.

Use of cellular HIV DNA to predict virologic response to maraviroc: performance of population-based and deep sequencing.

Swenson LC, Dong WW, Mo T, Demarest J, Chapman D, Ellery S, Heera J, Valdez H, Poon AF, Harrigan PR.

Clin Infect Dis. 2013 Jun;56(11):1659-66. doi: 10.1093/cid/cit105. Epub 2013 Feb 21.

PMID:
23429552
21.

Comparison of population and 454 "deep" sequence analysis for HIV type 1 tropism versus the original trofile assay in non-B subtypes.

Lee GQ, Harrigan PR, Dong W, Poon AF, Heera J, Demarest J, Rinehart A, Chapman D, Valdez H, Portsmouth S.

AIDS Res Hum Retroviruses. 2013 Jun;29(6):979-84. doi: 10.1089/AID.2012.0338. Epub 2013 Mar 6.

22.

Maraviroc once-daily nucleoside analog-sparing regimen in treatment-naive patients: randomized, open-label pilot study.

Mills A, Mildvan D, Podzamczer D, Fätkenheuer G, Leal M, Than S, Valluri SR, Craig C, McFadyen L, Vourvahis M, Heera J, Valdez H, Rinehart AR, Portsmouth S.

J Acquir Immune Defic Syndr. 2013 Feb 1;62(2):164-70. doi: 10.1097/QAI.0b013e31827b51b5.

PMID:
23187936
23.

Correlation between genotypic (V3 population sequencing) and phenotypic (Trofile ES) methods of characterizing co-receptor usage of HIV-1 from 200 treatment-naïve HIV patients screened for Study A4001078.

Portsmouth S, Valluri SR, Däumer M, Thiele B, Valdez H, Lewis M, Craig C, Thielen A, James I, Demarest J, Heera J.

Antiviral Res. 2013 Jan;97(1):60-5. doi: 10.1016/j.antiviral.2012.11.002. Epub 2012 Nov 16.

PMID:
23165088
24.

Population-based sequencing of the V3-loop can predict the virological response to maraviroc in treatment-naive patients of the MERIT trial.

McGovern RA, Thielen A, Portsmouth S, Mo T, Dong W, Woods CK, Zhong X, Brumme CJ, Chapman D, Lewis M, James I, Heera J, Valdez H, Harrigan PR.

J Acquir Immune Defic Syndr. 2012 Nov 1;61(3):279-86. doi: 10.1097/QAI.0b013e31826249cf.

PMID:
23095934
25.

Safety profile of maraviroc in patients coinfected with HIV-1 and hepatitis B or C included in the maraviroc expanded access program.

Lazzarin A, Than S, Valluri SR, Heera J, Mukwaya G.

HIV Clin Trials. 2012 Mar-Apr;13(2):83-9. doi: 10.1310/hct1302-83.

PMID:
22510355
26.

Deep V3 sequencing for HIV type 1 tropism in treatment-naive patients: a reanalysis of the MERIT trial of maraviroc.

Swenson LC, Mo T, Dong WW, Zhong X, Woods CK, Thielen A, Jensen MA, Knapp DJ, Chapman D, Portsmouth S, Lewis M, James I, Heera J, Valdez H, Harrigan PR.

Clin Infect Dis. 2011 Oct;53(7):732-42. doi: 10.1093/cid/cir493.

PMID:
21890778
27.

Mutations in gp41 are correlated with coreceptor tropism but do not improve prediction methods substantially.

Thielen A, Lengauer T, Swenson LC, Dong WW, McGovern RA, Lewis M, James I, Heera J, Valdez H, Harrigan PR.

Antivir Ther. 2011;16(3):319-28. doi: 10.3851/IMP1769.

PMID:
21555814
28.

Reanalysis of coreceptor tropism in HIV-1-infected adults using a phenotypic assay with enhanced sensitivity.

Wilkin TJ, Goetz MB, Leduc R, Skowron G, Su Z, Chan ES, Heera J, Chapman D, Spritzler J, Reeves JD, Gulick RM, Coakley E.

Clin Infect Dis. 2011 Apr 1;52(7):925-8. doi: 10.1093/cid/cir072.

29.

Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial.

MacInnes A, Lazzarin A, Di Perri G, Sierra-Madero JG, Aberg J, Heera J, Rajicic N, Goodrich J, Mayer H, Valdez H.

HIV Clin Trials. 2011 Jan-Feb;12(1):24-36. doi: 10.1310/hct1201-24.

PMID:
21388938
30.

Deep sequencing to infer HIV-1 co-receptor usage: application to three clinical trials of maraviroc in treatment-experienced patients.

Swenson LC, Mo T, Dong WW, Zhong X, Woods CK, Jensen MA, Thielen A, Chapman D, Lewis M, James I, Heera J, Valdez H, Harrigan PR.

J Infect Dis. 2011 Jan 15;203(2):237-45. doi: 10.1093/infdis/jiq030.

31.

Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients.

Funderburg N, Kalinowska M, Eason J, Goodrich J, Heera J, Mayer H, Rajicic N, Valdez H, Lederman MM.

PLoS One. 2010 Oct 6;5(10):e13188. doi: 10.1371/journal.pone.0013188.

32.

Hepatic safety and tolerability in the maraviroc clinical development program.

Ayoub A, Alston S, Goodrich J, Heera J, Hoepelman AI, Lalezari J, Mchale M, Nelson M, van der Ryst E, Mayer H.

AIDS. 2010 Nov 13;24(17):2743-50. doi: 10.1097/QAD.0b013e32833f9ce2.

PMID:
20935557
33.

Population-based V3 genotypic tropism assay: a retrospective analysis using screening samples from the A4001029 and MOTIVATE studies.

McGovern RA, Thielen A, Mo T, Dong W, Woods CK, Chapman D, Lewis M, James I, Heera J, Valdez H, Harrigan PR.

AIDS. 2010 Oct 23;24(16):2517-25. doi: 10.1097/QAD.0b013e32833e6cfb.

PMID:
20736814
34.

Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study.

Sierra-Madero J, Di Perri G, Wood R, Saag M, Frank I, Craig C, Burnside R, McCracken J, Pontani D, Goodrich J, Heera J, Mayer H.

HIV Clin Trials. 2010 May-Jun;11(3):125-32. doi: 10.1310/hct1103-125.

PMID:
20736149
35.

Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2.

Hardy WD, Gulick RM, Mayer H, Fätkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J.

J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.

36.

Hemodynamic effects of single-dose vardenafil in subjects receiving maraviroc.

Vourvahis M, Fang J, Huyghe I, Heera J.

J Acquir Immune Defic Syndr. 2010 Jul;54(3):336-8. doi: 10.1097/QAI.0b013e3181d01c3c. No abstract available.

PMID:
20571416
37.

Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection.

Cooper DA, Heera J, Goodrich J, Tawadrous M, Saag M, Dejesus E, Clumeck N, Walmsley S, Ting N, Coakley E, Reeves JD, Reyes-Teran G, Westby M, Van Der Ryst E, Ive P, Mohapi L, Mingrone H, Horban A, Hackman F, Sullivan J, Mayer H.

J Infect Dis. 2010 Mar 15;201(6):803-13. doi: 10.1086/650697.

PMID:
20151839
38.

Gamma interferon production in response to Mycobacterium bovis BCG and Mycobacterium tuberculosis antigens in infants born to human immunodeficiency virus-infected mothers.

Van Rie A, Madhi SA, Heera JR, Meddows-Taylor S, Wendelboe AM, Anthony F, Violari A, Tiemessen CT.

Clin Vaccine Immunol. 2006 Feb;13(2):246-52.

39.

Use of procalcitonin and C-reactive protein to evaluate vaccine efficacy against pneumonia.

Madhi SA, Heera JR, Kuwanda L, Klugman KP.

PLoS Med. 2005 Feb;2(2):e38. Epub 2005 Feb 22.

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