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1
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33845366857
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Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naíve HIV-1-infected individuals
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Markowitz M, Morales-Ramirez JO, Nguyen BY, et al. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naíve HIV-1-infected individuals. J Acquir Immune Defic Syndr 2006; 43:509-515.
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J Acquir Immune Defic Syndr
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Markowitz, M.1
Morales-Ramirez, J.O.2
Nguyen, B.Y.3
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2
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34548065793
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Metabolism and disposition in humans of raltegravir (MK-0518), an anti-AIDS drug targeting the human immunodeficiency virus 1 integrase enzyme
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Kassahun K, McIntosh I, Cui D, et al. Metabolism and disposition in humans of raltegravir (MK-0518), an anti-AIDS drug targeting the human immunodeficiency virus 1 integrase enzyme. Drug Metab Dispos 2007; 35:1657- 1663.
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Drug Metab Dispos
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Kassahun, K.1
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Isentress [package insert]. Whitehouse Station, NJ: Merck & Co. Inc.; 2011.
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Isentress
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4
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79952077699
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Clinical pharmacokineticand pharmacodynamic profile of the HIV integrase inhibitor elvitegravir
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Ramanathan S, Mathias AA, German P, Kearney BP. Clinical pharmacokineticand pharmacodynamic profile of the HIV integrase inhibitor elvitegravir. ClinPharmacokinet 2011; 50:229-244.
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Clin. Pharmacokinet
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Ramanathan, S.1
Mathias, A.A.2
German, P.3
Kearney, B.P.4
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5
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33748113778
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Antiviral activity, pharmacokinetics, and dose response of the HIV-1 integrase inhibitor GS-9137 (JTK-303) in treatment-naive and treatment-experienced patients
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DeJesus E, Berger D, Markowitz M, et al. Antiviral activity, pharmacokinetics, and dose response of the HIV-1 integrase inhibitor GS-9137 (JTK-303) in treatment-naive and treatment-experienced patients. J Acquir Immune Defic Syndr 2006; 43:1-5.
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J Acquir Immune Defic Syndr.
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DeJesus, E.1
Berger, D.2
Markowitz, M.3
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6
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57749197592
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Dose-response of ritonavir on hepatic CYP3A activity and elvitegravir oral exposure
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Mathias AA, West S, Hui J, et al. Dose-response of ritonavir on hepatic CYP3A activity and elvitegravir oral exposure. Clin Pharmacol Ther 2009; 85:64-70.
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Clin Pharmacol Ther
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Mathias, A.A.1
West, S.2
Hui, J.3
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7
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78049293198
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Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dosecombination regimen for the treatment of HIV
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German P, Warren D, West S, et al. Pharmacokinetics and bioavailability of an integrase and novel pharmacoenhancer-containing single-tablet fixed-dosecombination regimen for the treatment of HIV. J Acquir Immune Defic Syndr 2010; 55:323-329.
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J Acquir Immune Defic Syndr
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, pp. 323-329
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German, P.1
Warren, D.2
West, S.3
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8
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84898609803
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Effect of food on pharmacokinetics of elvitegravir, emtricitabine, tenofovir DF and the pharmacoenhancer GS-9350 as a fixed-dose combination tablet
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September 12-15, San Francisco, CA. Poster A1-1300
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German P, Warren D, Wei L, et al. Effect of food on pharmacokinetics of elvitegravir, emtricitabine, tenofovir DF and the pharmacoenhancer GS-9350 as a fixed-dose combination tablet. 49th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 12-15, 2009; San Francisco, CA. Poster A1-1300.
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(2009)
49th Interscience Conference on Antimicrobial Agents and Chemotherapy
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German, P.1
Warren, D.2
Wei, L.3
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9
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84872673452
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Pharmacokinetics of elvitegravir and cobicistat in subjects with severe renal impairment
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April; Barcelona, Spain. Abstract P/38
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German P, Wei X, Mizuno V, et al. Pharmacokinetics of elvitegravir and cobicistat in subjects with severe renal impairment. 13th International Workshop on Clinical Pharmacology of HIV Therapy; April 16-18, 2012; Barcelona, Spain. Abstract P/38.
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(2012)
13th International Workshop on Clinical Pharmacology of HIV Therapy
, pp. 16-18
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German, P.1
Wei, X.2
Mizuno, V.3
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10
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84872652807
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Pharmacokinetics and safety of boosted-elvitegravir in subjects with hepatic impairment
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April; Barcelona, Spain. Abstract P/40
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Ramanathan S, Rhee M, Shen G, et al. Pharmacokinetics and safety of boosted-elvitegravir in subjects with hepatic impairment. 13th International Workshop on Clinical Pharmacology of HIV Therapy; April 16-18, 2012; Barcelona, Spain. Abstract P/40.
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(2012)
13th International Workshop on Clinical Pharmacology of HIV Therapy
, pp. 16-18
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Ramanathan, S.1
Rhee, M.2
Shen, G.3
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11
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73849124557
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Pharmacokinetics and safety of S/ GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers
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Min S, Song I, Borland J, et al. Pharmacokinetics and safety of S/ GSK1349572, a next-generation HIV integrase inhibitor, in healthy volunteers. Antimicrob Agents Chemother 2010; 54:254-258.
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(2010)
Antimicrob Agents Chemother
, Issue.54
, pp. 254-258
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Min, S.1
Song, I.2
Borland, J.3
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12
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80052399651
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Antiviral activity, safety, and pharmacokinetics/ pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1- infected adults
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This study rovides a comrehensive evaluation of dolutegravir harmacokinetics inter-atient variability and harmacodynamics following multile doses
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Min S, Sloan L, DeJesus E, et al. Antiviral activity, safety, and pharmacokinetics/ pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1- infected adults. AIDS 2011; 25:1737-1745. This study provides a comprehensive evaluation of dolutegravir pharmacokinetics, inter-patient variability, and pharmacodynamics following multiple doses.
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(2011)
AIDS
, Issue.25
, pp. 1737-1745
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Min, S.1
Sloan, L.2
DeJesus, E.3
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13
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84863115993
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Effect of food on the pharmacokinetics of the integrase inhibitor dolutegravir
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This study concluded that although food results in higher dolutegravir exosure this change is unlikely to alter safety or efficacy
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Song I, Borland J, Chen S, et al. Effect of food on the pharmacokinetics of the integrase inhibitor dolutegravir. Antimicrob Agents Chemother 2012; 56:1627-1629. This study concluded that although food results in higher dolutegravir exposure, this change is unlikely to alter safety or efficacy.
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(2012)
Antimicrob Agents Chemother
, Issue.56
, pp. 1627-1629
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Song, I.1
Borland, J.2
Chen, S.3
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14
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84872660007
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Pharmacokinetics of dolutegravir in subjects with moderate hepatic impairment
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March; Seattle, WA. Paper #608
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Song I, Borland J, Savina P, et al. Pharmacokinetics of dolutegravir in subjects with moderate hepatic impairment. 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle, WA. Paper #608.
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(2012)
19th Conference on Retroviruses and Opportunistic Infections
, pp. 5-8
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Song, I.1
Borland, J.2
Savina, P.3
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15
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84855841557
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Inter- and intra-patient variability of raltegravir pharmacokinetics in HIV-1 infected subjects
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HIV-infected atients on a regimen containing raltegravir had raltegravir concentrations measured over 4 h at two consecutive visits and showed highly variable harmacokinetics both between atients and within the same atients on different days
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Cattaneo D, Gervasoni C, Meraviglia P, et al. Inter- and intra-patient variability of raltegravir pharmacokinetics in HIV-1 infected subjects. J Antimicrob Chemother 2012; 67:460-464. HIV-infected patients on a regimen containing raltegravir had raltegravir concentrations measured over 4 h at two consecutive visits and showed highly variable pharmacokinetics both between patients and within the same patients on different days.
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(2012)
J Antimicrob Chemother
, Issue.67
, pp. 460-464
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Cattaneo, D.1
Gervasoni, C.2
Meraviglia, P.3
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16
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81855166275
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Raltegravir once daily or twice daily in previously untreated patients with HIV-1: A randomized, active-controlled, phase 3 noninferiority trial
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Raltegravir 800mg once daily roduced virologic resonse rates of 83% comared with 89% for raltegravir 400mg twice daily but the time to achieve confirmed virologic resonse was longer in the once-daily grou and there were lower resonse rates for atients with baseline viral loads above 100 000 coies/ml or with CD4 cell counts below 200 cells/ul The authors concluded that raltegravir 800mg once daily cannot be recommended in lace of 400 mg twice daily
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Eron JJ, Rockstroh JK, Reynes J, et al. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: A randomized, active-controlled, phase 3 noninferiority trial. Lancet Infect Dis 2011; 11:907-915. Raltegravir 800mg once daily produced virologic response rates of 83% compared with 89% for raltegravir 400mg twice daily, but the time to achieve confirmed virologic response was longer in the once-daily group and there were lower response rates for patients with baseline viral loads above 100 000 copies/ml or with CD4 cell counts below 200 cells/ul. The authors concluded that raltegravir 800mg once daily cannot be recommended in place of 400 mg twice daily.
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(2011)
Lancet Infect Dis
, Issue.11
, pp. 907-915
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Eron, J.J.1
Rockstroh, J.K.2
Reynes, J.3
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17
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84872649716
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Feb; San Francisco, CA. Paper #873
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Nachman S, Samson P, Acosta E, et al. Pharmacokinetic (PK), safety, and efficacy data on cohort IIA: youth aged 6 to 11 years from IMPAACT P1066: A phase I/II study to evaluate raltegravir (RAL) in HIV-1 infected youth. 17th Conference on Retroviruses and Opportunistic Infections; Feb 16-19, 2010; San Francisco, CA. Paper #873.
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(2010)
Pharmacokinetic (PK), safety, and efficacy data on cohort IIA: Youth aged 6 to 11 years from IMPAACT P1066: A phase I/II study to evaluate raltegravir (RAL) in HIV-1 infected youth. 17th Conference on Retroviruses and Opportunistic Infections
, pp. 16-19
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Nachman, S.1
Samson, P.2
Acosta, E.3
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19
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84872660420
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A pharmacologic comparison of adult and pediatric formulations of raltegravir (RAL) in healthy adults
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San Francisco, CA. Paper #872 February
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Brainard DM, Gendrano IN, Jin B, et al. A pharmacologic comparison of adult and pediatric formulations of raltegravir (RAL) in healthy adults. 17th Conference on Retroviruses and Opportunistic Infections; February 16-19, 2010; San Francisco, CA. Paper #872.
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(2010)
17th Conference on Retroviruses and Opportunistic Infections
, pp. 16-19
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Brainard, D.M.1
Gendrano, I.N.2
Jin, B.3
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20
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66949149605
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Effect of rifampin, a potent inducer of drug-metabolizing enzymes, on the pharmacokinetics of raltegravir
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Wenning LA, Hanley WD, Brainard DM, et al. Effect of rifampin, a potent inducer of drug-metabolizing enzymes, on the pharmacokinetics of raltegravir. Antimicrob Agents Chemother 2009; 53:2852-2856.
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(2009)
Antimicrob Agents Chemother
, vol.53
, pp. 2852-2856
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Wenning, L.A.1
Hanley, W.D.2
Brainard, D.M.3
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21
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46249087089
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Atazanavir modestly increases plasma levels of raltegravir in healthy subjects
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Iwamoto M, Wenning LA, Petry AS, et al. Atazanavir modestly increases plasma levels of raltegravir in healthy subjects. Clin Infect Dis 2008; 47:137- 140.
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(2008)
Clin Infect Dis
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Iwamoto, M.1
Wenning, L.A.2
Petry, A.S.3
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22
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81755184134
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Plasma and intracellular pharmacokinetics of darunavir/ritonavir once daily and raltegravir once and twice daily in HIV-1 infected individuals
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The interaction between raltegravir and darunavir was assessed in HIV-ositive atients on an ARV regimen Overall no remarkable interactions were seen between raltegravir and darunavir
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Jackson A, Watson V, Back D, et al. Plasma and intracellular pharmacokinetics of darunavir/ritonavir once daily and raltegravir once and twice daily in HIV-1 infected individuals. J Acquir Immune Defic Syndr 2011; 58:450-457. The interaction between raltegravir and darunavir was assessed in HIV-positive patients on an ARV regimen. Overall, no remarkable interactions were seen between raltegravir and darunavir.
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(2011)
J Acquir Immune Defic Syndr
, Issue.58
, pp. 450-457
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Jackson, A.1
Watson, V.2
Back, D.3
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23
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79959245885
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Switch from enfuvirtide to raltegravir lowers plasma concentrations of darunavir and tipranavir: A pharmacokinetic substudy of the EASIER-ANRS 138 trail
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The concentrations of darunavir and tiranavir were measured in HIV-infected atients before and after switching from enfuvirtide to raltegravir AUC trough concentrations and Cmax were decreased for both darunavir and tiranavir but the clinical imact of those decreases is unknown
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Goldwirt L, Braun J, de Castro N, et al. Switch from enfuvirtide to raltegravir lowers plasma concentrations of darunavir and tipranavir: A pharmacokinetic substudy of the EASIER-ANRS 138 trail. Antimicrob Agents Chemother 2011; 55:3613-3615. The concentrations of darunavir and tipranavir were measured in HIV-infected patients before and after switching from enfuvirtide to raltegravir. AUC, trough concentrations, and Cmax were decreased for both darunavir and tipranavir, but the clinical impact of those decreases is unknown.
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(2011)
Antimicrob Agents Chemother
, Issue.55
, pp. 3613-3615
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Goldwirt, L.1
Braun, J.2
De Castro, N.3
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24
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66949126977
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Effect of tipranavir-ritonavir on pharmacokinetics of raltegravir
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Hanley WD, Wenning LA, Moreau A, et al. Effect of tipranavir-ritonavir on pharmacokinetics of raltegravir. Antimicrob Agents Chemother 2009; 53:2752-2755.
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(2009)
Antimicrob Agents Chemother
, vol.53
, pp. 2752-2755
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Hanley, W.D.1
Wenning, L.A.2
Moreau, A.3
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25
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84856072387
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Pharmacokinetic effects of coadministration of lersivirine with raltegravir or maraviroc in healthy subjects
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The concentration changes of raltegravir when co-administered with lersivirinewere measured at steady state Clinically nonsignificant decrease in mean AUCand Cmax were observed and increase in mean trough concentrations
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Vourvahis M, Langdon G, LaBadie RR, et al. Pharmacokinetic effects of coadministration of lersivirine with raltegravir or maraviroc in healthy subjects. Antimicrob Agents Chemother 2012; 56:887-892. The concentration changes of raltegravir when co-administered with lersivirinewere measured at steady state. Clinically nonsignificant decrease in mean AUCand Cmax were observed, and increase in mean trough concentrations.
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(2012)
Antimicrob Agents Chemother
, Issue.56
, pp. 887-892
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Vourvahis, M.1
Langdon, G.2
LaBadie, R.R.3
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26
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84865636976
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Absence of pharmacokineticinteraction between the NNRTI rilpivirine (TMC278) and the integrase inhibitor raltegravir
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Mar; Seattle, WA. Paper #617
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Crauwels H, Stevens M, De La Rosa G, Boven K. Absence of pharmacokineticinteraction between the NNRTI rilpivirine (TMC278) and the integrase inhibitor raltegravir. 19th Conference on Retroviruses and OpportunisticInfections; Mar 5-8 2012; Seattle, WA. Paper #617.
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(2012)
19th Conference on Retroviruses and OpportunisticInfections
, pp. 5-8
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Crauwels, H.1
Stevens, M.2
De La Rosa, G.3
Boven, K.4
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27
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84870764818
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HIV and Viral Hepatitis. Atlanta,GA. Available from. Last Updated 17 Nov 2011. Accessed March 2012
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HIV and Viral Hepatitis. Center for Disease Control and Prevention. Atlanta,GA. Available from: http://www.cdc.gov/hiv/resources/factsheets/ hepatitis.htm. Last Updated 17 Nov 2011. Accessed March 2012.
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Center for Disease Control and Prevention
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28
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79956045755
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Pharmacokinetic and safety profile ofraltegravir and ribavirin, when dosed separately and together, in healthyvolunteers
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The interaction between raltegravir and ribavirin was assessed in healthyvolunteers. No significant differences in the pharmacokinetic parameters of raltegravirwere observed, but the ribavirin Cmax was decreased and Tmax increased
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Ashby J, Garvey L, Erlwein OW, et al. Pharmacokinetic and safety profile ofraltegravir and ribavirin, when dosed separately and together, in healthyvolunteers. J Antimicrob Chemother 2011; 66:1340-1345.The interaction between raltegravir and ribavirin was assessed in healthyvolunteers. No significant differences in the pharmacokinetic parameters of raltegravirwere observed, but the ribavirin Cmax was decreased and Tmax increased.
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(2011)
J Antimicrob Chemother
, vol.66
, pp. 1340-1345
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Ashby, J.1
Garvey, L.2
Erlwein, O.W.3
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29
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84887844699
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The influence of the HCV protease inhibitor bocepravir on the pharmacokinetics of the HIV integrase inhibitor raltegravir
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Mar 5-8,; Seattle, WA. Paper #772LB. The interaction between bocepravir and raltegravir was assessed in healthy individuals and bocepravir was not found to affect raltegravir exposure
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de Kanter C, Blonk M, Colbers A, et al. The influence of the HCV protease inhibitor bocepravir on the pharmacokinetics of the HIV integrase inhibitor raltegravir. 19th Conference on Retroviruses and Opportunistic Infections;Mar 5-8, 2012; Seattle, WA. Paper #772LB. The interaction between bocepravir and raltegravir was assessed in healthy individuals and bocepravir was not found to affect raltegravir exposure.
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(2012)
19th Conference on Retroviruses and Opportunistic Infections
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De Kanter, C.1
Blonk, M.2
Colbers, A.3
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30
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84860266663
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The pharmacokinetic interaction between telaprevir and raltegravir in healthy volunteers
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Se 17-20,; Chicago, IL LB A1-I1738a The interaction between telaprevir and raltegravir was studied in healthvolunteers and a clinically insignificant increase in raltegravir exposures wasobserved
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van Heeswijk R, Garg V, Boogaerts G, et al. The pharmacokinetic interaction between telaprevir and raltegravir in healthy volunteers. 51st InterscienceConference on Antimicrobial Agents and Chemotherapy; Se 17-20, 2012; Chicago, IL. LB A1-1738a. The interaction between telaprevir and raltegravir was studied in healthvolunteers and a clinically insignificant increase in raltegravir exposures wasobserved.
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(2012)
51st InterscienceConference on Antimicrobial Agents and Chemotherapy
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Van Heeswijk, R.1
Garg, V.2
Boogaerts, G.3
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31
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0033006714
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Comparative effects of rifabutin and rifampicin on cytochromes P450 and UDP-glucuronosyl-transferases expression in fresh and cryopreserved human hepatocytes
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Reinbach B, de Sousa G, Dostert P, et al. Comparative effects of rifabutin and rifampicin on cytochromes P450 and UDP-glucuronosyl-transferases expression in fresh and cryopreserved human hepatocytes. Chem BiolInteract 1999; 121:37-48.
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Chem BiolInteract
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Reinbach, B.1
De Sousa, G.2
Dostert, P.3
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32
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79955796501
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Lack of a clinically meaningful pharmacokinetic effect of rifabutin on raltegravir: in vitro/in vivo correlation
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Rifabutin was not found to alter raltegravir pharmacokinetics to a clinically meaningful extent in vivo
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Brainard DM, Kassahun K, Wenning LA, et al. Lack of a clinically meaningful pharmacokinetic effect of rifabutin on raltegravir: in vitro/in vivo correlation.J Clin Pharmacol 2011; 51:943-950. Rifabutin was not found to alter raltegravir pharmacokinetics to a clinically meaningful extent in vivo.
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(2011)
J Clin Pharmacol
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Brainard, D.M.1
Kassahun, K.2
Wenning, L.A.3
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Lack of a significant drug interaction between raltegravir and tenofovir
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Wenning LA, Friedman EJ, Kost JT, et al. Lack of a significant drug interaction between raltegravir and tenofovir. Antimicrob Agents Chemother 2008;52:3253-3258.
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Antimicrob Agents Chemother
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Wenning, L.A.1
Friedman, E.J.2
Kost, J.T.3
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34
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78649681819
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Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers
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Kiser JJ, Bumpass JB, Meditz AL, et al. Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers. Antimicrob Agents Chemother 2010; 54:4999-5003.
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Antimicrob Agents Chemother
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Kiser, J.J.1
Bumpass, J.B.2
Meditz, A.L.3
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35
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34748824953
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Pharmacokinetics of coadministered ritonavir-boosted elvitegravir and zidovudine, didanosine, stavudine, orabacavir
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Ramanathan R, Shen G, Hinkle J, et al. Pharmacokinetics of coadministered ritonavir-boosted elvitegravir and zidovudine, didanosine, stavudine, orabacavir. J Acquir Immune Defic Syndr 2007; 46:160-166.
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(2007)
J Acquir Immune Defic Syndr
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, pp. 160-166
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Ramanathan, R.1
Shen, G.2
Hinkle, J.3
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36
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34347347164
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Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137
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Ramanathan S, Shen G, Cheng A, et al. Pharmacokinetics of emtricitabine, tenofovir, and GS-9137 following coadministration of emtricitabine/tenofovir disoproxil fumarate and ritonavir-boosted GS-9137. J Acquir Immune DeficSyndr 2007; 45:274-279.
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(2007)
J Acquir Immune DeficSyndr
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Ramanathan, S.1
Shen, G.2
Cheng, A.3
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37
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58149489322
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Pharmacokinetics of elvitegravir and etravirine following coadministration of ritonavir-boosted elvitegravir and etravirine
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Ramanathan S, Kakuda TN, Mack R, et al. Pharmacokinetics of elvitegravir and etravirine following coadministration of ritonavir-boosted elvitegravir and etravirine. Antivir Ther 2008; 13:1011-1017.
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Antivir Ther
, vol.13
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Ramanathan, S.1
Kakuda, T.N.2
Mack, R.3
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38
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55249116493
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Effect of ritonavir-boosted tipranavir or darunavir on the steady-state pharmacokinetics of elvitegravir
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Mathias AA, Hinkle J, Shen G, et al. Effect of ritonavir-boosted tipranavir or darunavir on the steady-state pharmacokinetics of elvitegravir. J Acquir Immune Defic Syndr 2008; 49:156-162.
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J Acquir Immune Defic Syndr
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, pp. 156-162
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Mathias, A.A.1
Hinkle, J.2
Shen, G.3
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39
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42149147700
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Lack of clinically relevant drug-drug interaction between ritonavir-boosted GS-9137 (elvitegravir) and fosamprenavir/r
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July 22-25,rfsti Sydney, Australia. Abstract WEPEB014
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Ramanathan S, Mathias AA, Shen G, et al. Lack of clinically relevant drug-drug interaction between ritonavir-boosted GS-9137 (elvitegravir) and fosamprenavir/r. 4th IAS Conference on HIV Pathogenesis, Treatment, and Prevention; July 22-25, 2007; Sydney, Australia. Abstract WEPEB014.
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(2007)
4th IAS Conference on HIV Pathogenesis, Treatment, and Prevention
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Ramanathan, S.1
Mathias, A.A.2
Shen, G.3
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40
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84872648477
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47th Interscience Conferenceon Antimicrobial Agents And Chemotherapy September 17-20, 2007;Chicago, IL. Abstract A-1417
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Mathias A, Ramanathan S, Hinkle J, et al. Effect of atazanavir/r on the steady state pharmacokinetics of elvitegravir. 47th Interscience Conferenceon Antimicrobial Agents and Chemotherapy; September 17-20, 2007;Chicago, IL. Abstract A-1417.
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Effect Of Atazanavirr On The Steady State Pharmacokinetics Of Elvitegravir
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Mathias, A.1
Ramanathan, S.2
Hinkle, J.3
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41
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84887484928
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Pharmacokinetics and drug interaction profile of cobicistat boosted-EVG with atazanavir, rosuvastatinor rifabutin
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Apr 16-18,; Barcelona, Spain. Abstract O/03. Co-administration of rifabutin and cobicistat-boosted elvitegravir resulted intrough concentrations lower than those expected from data with rifabutin and ritonavir-boosted elvitegravir. This study also assessed pharmacokinetics forelvitegravir/ cobicistat administered with atazanavir or rosuvastatin
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Ramanathan S, Wang H, Stondell T, et al. Pharmacokinetics and drug interaction profile of cobicistat boosted-EVG with atazanavir, rosuvastatinor rifabutin. 13th International Workshop on Clinical Pharmacology of HIV Therapy; Apr 16-18, 2012; Barcelona, Spain. Abstract O/03. Co-administration of rifabutin and cobicistat-boosted elvitegravir resulted intrough concentrations lower than those expected from data with rifabutin and ritonavir-boosted elvitegravir. This study also assessed pharmacokinetics forelvitegravir/cobicistat administered with atazanavir or rosuvastatin.
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(2012)
13th International Workshop on Clinical Pharmacology of HIV Therapy
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Ramanathan, S.1
Wang, H.2
Stondell, T.3
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42
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42149139799
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A pharmacokinetic interaction between lopinavirr and elvitegravir
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September 17-20,; Chicago, IL.Abstract A-1418
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Mathias A, Ramanathan S, Hinkle J, et al. A pharmacokinetic interaction between lopinavir/r and elvitegravir. 47th Interscience Conference on AntimicrobialAgents and Chemotherapy; September 17-20, 2007; Chicago, IL.Abstract A-1418.
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(2007)
47th Interscience Conference On AntimicrobialAgents And Chemotherapy
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Mathias, A.1
Ramanathan, S.2
Hinkle, J.3
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43
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75649141590
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Pharmacokinetic interaction ofritonavir-boosted elvitegravir and maraviroc
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Ramanathan S, Abel S, Tweedy S, et al. Pharmacokinetic interaction ofritonavir-boosted elvitegravir and maraviroc. J Acquir Immune Defic Syndr2010; 53:209-214.
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(2010)
J Acquir Immune Defic Syndr
, vol.53
, pp. 209-214
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Ramanathan, S.1
Abel, S.2
Tweedy, S.3
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44
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83655194024
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Pharmacokinetic interaction between elvitegravirritonavir and dose-adjusted rifabutin
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April 7-9, 2008; New Orleans, LA. Abstract P19
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German P, West S, Hui J, et al. Pharmacokinetic interaction between elvitegravir/ritonavir and dose-adjusted rifabutin. 9th International Workshopon Clinical Pharmacology of HIV Therapy; April 7-9, 2008; New Orleans, LA. Abstract P19.
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9th International Workshopon Clinical Pharmacology Of HIV Therapy
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German, P.1
West, S.2
Hui, J.3
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46
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84872660765
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Effect of acid reducing agents on the relativebioavailability and pharmacokinetics of cobicistat-boosted elvitegravir
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April 13- 15, 2011; Miami, FL. Abstract P/13
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Mathias A, Koziara J, Wei L, et al. Effect of acid reducing agents on the relativebioavailability and pharmacokinetics of cobicistat-boosted elvitegravir. 12thInternational Workshop on Clinical Pharmacology of HIV Therapy; April 13- 15, 2011; Miami, FL. Abstract P/13.
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12thInternational Workshop on Clinical Pharmacology of HIV Therapy
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Mathias, A.1
Koziara, J.2
Wei, L.3
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47
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78049297410
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Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects
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Song I, Min SS, Borland J, et al. Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects. J Acquir ImmuneDefic Syndr 2010; 55:365-367.
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(2010)
J Acquir ImmuneDefic Syndr
, vol.55
, pp. 365-367
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Song, I.1
Min, S.S.2
Borland, J.3
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48
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84886796936
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Effects of enzyme inducers, tipranavir and efavirenz, on the pharmacokinetics of the integrase inhibitor, dolutegravir (S/GSK1359572)
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April 13-15,rfpy1 2011; Miami, FL.Abstract O/02.Although significant decreases in dolutegravir exposure are observed withboth tipranavir and efavirenz, dolutegravir trough concentrations remain multi-foldabove the IC90
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Song I, Borland J, Lou Y, et al. Effects of enzyme inducers, tipranavir and efavirenz, on the pharmacokinetics of the integrase inhibitor, dolutegravir (S/GSK1359572). 12th International Workshop onClinical Pharmacology of HIV Therapy; April 13-15, 2011; Miami, FL.Abstract O/02.Although significant decreases in dolutegravir exposure are observed withboth tipranavir and efavirenz, dolutegravir trough concentrations remain multi-foldabove the IC90.
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12th International Workshop onClinical Pharmacology of HIV Therapy
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Song, I.1
Borland, J.2
Lou, Y.3
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49
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79959244325
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Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir
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This article explains the clinically important interaction between etravirineand dolutegravir and rescue of dolutegravir's pharmacokinetic profile by coadministrationof boosted protease inhibitors
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Song I, Borland J, Min S, et al. Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir.Antimicrob Agents Chemother 2011; 55:3517-3521. This article explains the clinically important interaction between etravirineand dolutegravir and rescue of dolutegravir's pharmacokinetic profile by coadministrationof boosted protease inhibitors.
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(2011)
Antimicrob Agents Chemother
, Issue.55
, pp. 3517-3521
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Song, I.1
Borland, J.2
Min, S.3
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50
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79551709965
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The effect of lopinavir/ritonavir and darunavir/ ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants
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This study provides evidence that dolutegravir does not participate in clinicallyimportant interactions with the protease inhibitors lopinavir/ritonavir and darunavir/ritonavir
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Song I, Min SS, Borland J, et al. The effect of lopinavir/ritonavir and darunavir/ ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants. J Clin Pharmacol 2011; 51:237-242.This study provides evidence that dolutegravir does not participate in clinicallyimportant interactions with the protease inhibitors lopinavir/ritonavir and darunavir/ritonavir.
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(2011)
J Clin Pharmacol
, vol.51
, pp. 237-242
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Song, I.1
Min, S.S.2
Borland, J.3
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51
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79958719816
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Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor,S/GSK1349572
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Although the investigators observed significant increases in dolutegravir exosurewith atazanavir and atazanavir/ritonavir likely due to UGT inhibition they concludethat these changes are unlikely to negatively imact theray
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Song I, Borland J, Chen S, et al. Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor,S/GSK1349572. Br J Clin Pharmacol 2011; 72:103-108. Although the investigators observed significant increases in dolutegravir exposurewith atazanavir and atazanavir/ritonavir, likely due to UGT inhibition, they concludethat these changes are unlikely to negatively impact therapy.
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(2011)
Br J Clin Pharmacol
, Issue.72
, pp. 103-108
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Song, I.1
Borland, J.2
Chen, S.3
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52
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51st Interscience Conference On Antimicrobial Agents And Chemotherapy;September 17-20 2011; Chicago, IL Abstract A1-IL Abstrac1727
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Song I, Borland J, Chen S, et al. Effect of fosamprenavir/ritonavir on the pharmacokinetics of the integrase inhibitor, dolutegravir, in healthy subjects. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy;September 17-20, 2011; Chicago, IL. Abstract A1-1727.
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Effect Of Fosamprenavirritonavir On The Pharmacokinetics Of The Integrase Inhibitor Dolutegravir In Healthy Subjects
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Song, I.1
Borland, J.2
Chen, S.3
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53
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84872657601
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Safety, tolerability, and pharmacokinetics ofthe HIV integrase inhibitor dolutegravir given twice daily with rifampin: Resultsof a Phase I study among healthy subjects
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March 5-8, 2012; Seattle, WA. Paper #148.This abstract provides evidence for increased dolutegravir dosing frequency whenadministered with rifampin
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Dooley KE, Purdy E, Sayre P, et al. Safety, tolerability, and pharmacokinetics ofthe HIV integrase inhibitor dolutegravir given twice daily with rifampin: resultsof a Phase I study among healthy subjects. 19th Conference on Retrovirusesand Opportunistic Infections; March 5-8, 2012; Seattle, WA. Paper #148.This abstract provides evidence for increased dolutegravir dosing frequency whenadministered with rifampin.
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19th Conference on Retrovirusesand Opportunistic Infections
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Dooley, K.E.1
Purdy, E.2
Sayre, P.3
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54
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Pharmacokinetics, safety, and tolerability of the HIV integrase inhibitor dolutegravir co-administered with rifabutin inhealthy subjects
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April 2012; Barcelona, Spain. Abstract P/11.Rifabutin can be co-administered with dolutegravir without dose adjustment,despite a 30% decrease in dolutegravir trough concentration
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Dooley KE, Sayre P, Borland J, et al. Pharmacokinetics, safety, and tolerability of the HIV integrase inhibitor dolutegravir co-administered with rifabutin inhealthy subjects. 13th International Workshop on Clinical Pharmacology ofHIV Therapy; April 16-18, 2012; Barcelona, Spain. Abstract P/11.Rifabutin can be co-administered with dolutegravir without dose adjustment,despite a 30% decrease in dolutegravir trough concentration.
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13th International Workshop on Clinical Pharmacology ofHIV Therapy
, pp. 16-18
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Dooley, K.E.1
Sayre, P.2
Borland, J.3
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55
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79958856040
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Pharmacokinetics of the HIV integraseinhibitor S/GSK1349572 co-administered with acid-reducing agents and multivitamins in healthy volunteers
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This article highlights the clinically important interaction between antacids anddolutegravir
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Patel P, Song I, Borland J, et al. Pharmacokinetics of the HIV integraseinhibitor S/GSK1349572 co-administered with acid-reducing agents and multivitamins in healthy volunteers. J Antimicrob Chemother 2011; 66:1567-1572.This article highlights the clinically important interaction between antacids anddolutegravir.
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(2011)
J Antimicrob Chemother
, vol.66
, pp. 1567-1572
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Patel, P.1
Song, I.2
Borland, J.3
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56
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Clinical pharmacology of the hiv integrase inhibitor elvitegravir
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October 24-27, 2007; Madrid, Spain. Abstract PS4/7
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Ramanathan S, Mathias AA, Hinkle J, Kearney BP. Clinical pharmacology of the HIV integrase inhibitor elvitegravir. 11th European AIDS Conference; October 24-27, 2007; Madrid, Spain. Abstract PS4/7.
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11th European AIDS Conference
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Ramanathan, S.1
Mathias, A.A.2
Hinkle, J.3
Kearney, B.P.4
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57
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Week 48 results of an ongoing phase 3 study comparing elvitegravir/cobicistat/emtricitabine/tenofovir (Quad) with atazanavir/ritonavir plus emtricitabine/tenofovir in treatment-naíve HIV-1 subjects showing efficacy, safety, and pharmacokinetics
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March 5-8, 2012; Seattle, WA. Paper #627
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DeJesus E, Rockstroh J, Henry K, et al. Week 48 results of an ongoing phase 3 study comparing elvitegravir/cobicistat/emtricitabine/tenofovir (Quad) with atazanavir/ritonavir plus emtricitabine/tenofovir in treatment-naíve HIV-1; subjects showing efficacy, safety, and pharmacokinetics. 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle, WA. Paper #627.
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19th Conference on Retroviruses and Opportunistic Infections
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DeJesus, E.1
Rockstroh, J.2
Henry, K.3
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58
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84863816714
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Elvitegravir/cobicistat/emtricitabine/tenofovir (Quad) has noninferior efficacy and favorable safety compared to efavirenz/ emtricitabine/tenofovir in treatment-naíve HIV-1 subjects
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March 5-8, 2012; Seattle, WA. Paper #101
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Sax P, DeJesus E, Millis A, et al. Elvitegravir/cobicistat/emtricitabine/ tenofovir (Quad) has noninferior efficacy and favorable safety compared to efavirenz/ emtricitabine/tenofovir in treatment-naíve HIV-1; subjects. 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle, WA. Paper #101.
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19th Conference on Retroviruses and Opportunistic Infections
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Sax, P.1
DeJesus, E.2
Millis, A.3
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59
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84155164041
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Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: Randomised, doubleblind, phase 3, noninferiority study
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This hase 3 clinical trial evaluates the safety and efficacy of once-daily ritonavirboosted elvitegravir with raltegravir as an active comarator
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Molina JM, Lamarca A, Andrade-Villanueva J, et al. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, doubleblind, phase 3, noninferiority study. Lancet Infect Dis 2012; 12:27-35. This phase 3 clinical trial evaluates the safety and efficacy of once-daily ritonavirboosted elvitegravir with raltegravir as an active comparator.
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(2012)
Lancet Infect Dis
, Issue.12
, pp. 27-35
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Molina, J.M.1
Lamarca, A.2
Andrade-Villanueva, J.3
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60
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Dolutegravir (DTG, s/GSK1349572) treatment of subjects with raltegravir (RAL) resistance: viral suppression at week 24 inVIKING study
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October 12-15,; Belgrade, Serbia. Abstract PS1/2
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Soriano V, Cox J, Eron JJ, et al. Dolutegravir (DTG, s/GSK1349572) treatment of subjects with raltegravir (RAL) resistance: viral suppression at week 24 inVIKING study. 13th European AIDS Conference; October 12-15, 2011; Belgrade, Serbia. Abstract PS1/2.
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(2011)
13th European AIDS Conference
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Soriano, V.1
Cox, J.2
Eron, J.J.3
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61
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84856226017
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Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: Planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial
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This hase 3 clinical trial rovides evidence for the efficacy and safety of dolutegravir in treatment-naíve atients
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van Lunzen J, Maggiolo F, Arribas JR, et al. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis 2012; 12:111-118. This phase 3 clinical trial provides evidence for the efficacy and safety of dolutegravir in treatment-naíve patients.
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(2012)
Lancet Infect Dis
, Issue.12
, pp. 111-118
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Van Lunzen, J.1
Maggiolo, F.2
Arribas, J.R.3
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62
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DTG in subjects with hiv exhibiting ral resistance: functional monotherapy results of VIKING study cohort II
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Feb 27-Mar 2 2011; Boston, MA. Paper #151LB
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Eron JJ, Kumar P, Lazzarin A, et al. DTG in subjects with HIV exhibiting RAL resistance: Functional monotherapy results of VIKING study cohort II. 18th Conference on Retroviruses and Opportunistic Infections; Feb 27-Mar 2, 2011; Boston, MA. Paper #151LB
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18th Conference on Retroviruses and Opportunistic Infections
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Eron, J.J.1
Kumar, P.2
Lazzarin, A.3
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63
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Dolutegravir in combination therapy exhibits rapid and sustained antiviral response in ARV-naive adults: 96-week results from SPRING-1 (ING112276)
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March 5-8, 2012; Seattle, WA. Paper #102LB
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Stellbrink HJ, Reynes J, Lazzarin A, et al. Dolutegravir in combination therapy exhibits rapid and sustained antiviral response in ARV-naive adults: 96-week results from SPRING-1 (ING112276). 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle, WA. Paper #102LB.
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19th Conference on Retroviruses and Opportunistic Infections
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Stellbrink, H.J.1
Reynes, J.2
Lazzarin, A.3
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64
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84896848743
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Pharmacokinetics of a dolutegravir pediatric granule formulation in healthy adult subjects
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March 5-8, 2012; Seattle, WA. Paper #985
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Patel P, Song I, Borland J, et al. Pharmacokinetics of a dolutegravir pediatric granule formulation in healthy adult subjects. 19th Conference on Retroviruses and Opportunistic Infections; March 5-8, 2012; Seattle, WA. Paper #985.
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19th Conference on Retroviruses and Opportunistic Infections
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Patel, P.1
Song, I.2
Borland, J.3
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GSK1265744 [Internet]. 2012 [cited 2012 May 31]. Available from
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Protocol Summaries: GSK1265744 [Internet]. 2012 [cited 2012 May 31]. Available from: http://www.gskclinicalstudyregister.com/protocol/comp/list. jsp;jsessionid02043C0461BBAF033065BDD0C951F31C? compoundGsk1265744.
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Protocol Summaries
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