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Items: 19


A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Patients With Hepatic Impairment and Healthy Matched Controls.

Shaik JSB, Ford SL, Lou Y, Zhang Z, Bakshi KK, Tenorio AR, Trezza C, Spreen WR, Patel P.

Clin Pharmacol Drug Dev. 2019 Feb 27. doi: 10.1002/cpdd.655. [Epub ahead of print]


A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants.

Parasrampuria R, Ford SL, Lou Y, Fu C, Bakshi KK, Tenorio AR, Trezza C, Spreen WR, Patel P.

Clin Pharmacol Drug Dev. 2019 Feb 27. doi: 10.1002/cpdd.664. [Epub ahead of print]


Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial.

Murray MI, Markowitz M, Frank I, Grant RM, Mayer KH, Hudson KJ, Stancil BS, Ford SL, Patel P, Rinehart AR, Spreen WR, Margolis DA.

HIV Clin Trials. 2018 Aug;19(4):129-138. doi: 10.1080/15284336.2018.1511346. Epub 2018 Nov 16.


Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial.

Landovitz RJ, Li S, Grinsztejn B, Dawood H, Liu AY, Magnus M, Hosseinipour MC, Panchia R, Cottle L, Chau G, Richardson P, Marzinke MA, Hendrix CW, Eshleman SH, Zhang Y, Tolley E, Sugarman J, Kofron R, Adeyeye A, Burns D, Rinehart AR, Margolis D, Spreen WR, Cohen MS, McCauley M, Eron JJ.

PLoS Med. 2018 Nov 8;15(11):e1002690. doi: 10.1371/journal.pmed.1002690. eCollection 2018 Nov.


Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial.

Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, Lutz T, Angel JB, Richmond GJ, Clotet B, Gutierrez F, Sloan L, Clair MS, Murray M, Ford SL, Mrus J, Patel P, Crauwels H, Griffith SK, Sutton KC, Dorey D, Smith KY, Williams PE, Spreen WR.

Lancet. 2017 Sep 23;390(10101):1499-1510. doi: 10.1016/S0140-6736(17)31917-7. Epub 2017 Jul 24.


Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial.

Markowitz M, Frank I, Grant RM, Mayer KH, Elion R, Goldstein D, Fisher C, Sobieszczyk ME, Gallant JE, Van Tieu H, Weinberg W, Margolis DA, Hudson KJ, Stancil BS, Ford SL, Patel P, Gould E, Rinehart AR, Smith KY, Spreen WR.

Lancet HIV. 2017 Aug;4(8):e331-e340. doi: 10.1016/S2352-3018(17)30068-1. Epub 2017 May 22.


Cabotegravir long acting injection protects macaques against intravenous challenge with SIVmac251.

Andrews CD, Bernard LS, Poon AY, Mohri H, Gettie N, Spreen WR, Gettie A, Russell-Lodrigue K, Blanchard J, Hong Z, Ho DD, Markowitz M.

AIDS. 2017 Feb 20;31(4):461-467. doi: 10.1097/QAD.0000000000001343.


Effect of Cabotegravir on Cardiac Repolarization in Healthy Subjects.

Lou Y, Buchanan AM, Chen S, Ford SL, Gould E, Margolis D, Spreen WR, Patel P.

Clin Pharmacol Drug Dev. 2016 Nov;5(6):509-516. doi: 10.1002/cpdd.272. Epub 2016 Jun 22.


Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial.

Margolis DA, Brinson CC, Smith GHR, de Vente J, Hagins DP, Eron JJ, Griffith SK, Clair MHS, Stevens MC, Williams PE, Ford SL, Stancil BS, Bomar MM, Hudson KJ, Smith KY, Spreen WR; LAI116482 Study Team.

Lancet Infect Dis. 2015 Oct;15(10):1145-1155. doi: 10.1016/S1473-3099(15)00152-8. Epub 2015 Jul 19.


Disposition and metabolism of cabotegravir: a comparison of biotransformation and excretion between different species and routes of administration in humans.

Bowers GD, Culp A, Reese MJ, Tabolt G, Moss L, Piscitelli S, Huynh P, Wagner D, Ford SL, Gould EP, Pan R, Lou Y, Margolis DA, Spreen WR.

Xenobiotica. 2016;46(2):147-62. doi: 10.3109/00498254.2015.1060372. Epub 2015 Jul 1.


A long-acting integrase inhibitor protects female macaques from repeated high-dose intravaginal SHIV challenge.

Andrews CD, Yueh YL, Spreen WR, St Bernard L, Boente-Carrera M, Rodriguez K, Gettie A, Russell-Lodrigue K, Blanchard J, Ford S, Mohri H, Cheng-Mayer C, Hong Z, Ho DD, Markowitz M.

Sci Transl Med. 2015 Jan 14;7(270):270ra4. doi: 10.1126/scitranslmed.3010298.


Long-acting integrase inhibitor protects macaques from intrarectal simian/human immunodeficiency virus.

Andrews CD, Spreen WR, Mohri H, Moss L, Ford S, Gettie A, Russell-Lodrigue K, Bohm RP, Cheng-Mayer C, Hong Z, Markowitz M, Ho DD.

Science. 2014 Mar 7;343(6175):1151-4. doi: 10.1126/science.1248707. Epub 2014 Mar 4.


Long-acting injectable antiretrovirals for HIV treatment and prevention.

Spreen WR, Margolis DA, Pottage JC Jr.

Curr Opin HIV AIDS. 2013 Nov;8(6):565-71. doi: 10.1097/COH.0000000000000002. Review.


Genetic association studies to detect adverse drug reactions: abacavir hypersensitivity as an example.

Hughes AR, Brothers CH, Mosteller M, Spreen WR, Burns DK.

Pharmacogenomics. 2009 Feb;10(2):225-33. doi: 10.2217/14622416.10.2.225. Review.


Pharmacogenetics of hypersensitivity to abacavir: from PGx hypothesis to confirmation to clinical utility.

Hughes AR, Spreen WR, Mosteller M, Warren LL, Lai EH, Brothers CH, Cox C, Nelsen AJ, Hughes S, Thorborn DE, Stancil B, Hetherington SV, Burns DK, Roses AD.

Pharmacogenomics J. 2008 Dec;8(6):365-74. doi: 10.1038/tpj.2008.3. Epub 2008 Mar 11. Review.


Use of pairwise marker combination and recursive partitioning in a pharmacogenetic genome-wide scan.

Warren LL, Hughes AR, Lai EH, Zaykin DV, Haneline SA, Bansal AT, Wooster AW, Spreen WR, Hernandez JE, Scott TR, Roses AD, Mosteller M; CNA30027 and CNA30032 study teams.

Pharmacogenomics J. 2007 Jun;7(3):180-9. Epub 2006 Sep 12.


HLA-B*5701 and abacavir hypersensitivity.

Watson ME, Pimenta JM, Spreen WR, Hernandez JE.

Pharmacogenetics. 2004 Nov;14(11):783-4; author reply 784. No abstract available.


Association of genetic variations in HLA-B region with hypersensitivity to abacavir in some, but not all, populations.

Hughes AR, Mosteller M, Bansal AT, Davies K, Haneline SA, Lai EH, Nangle K, Scott T, Spreen WR, Warren LL, Roses AD; CNA30027 Study Team; CNA30032 Study Team.

Pharmacogenomics. 2004 Mar;5(2):203-11.


CAMPATH-1H, a humanized monoclonal antibody, in refractory rheumatoid arthritis. An intravenous dose-escalation study.

Weinblatt ME, Maddison PJ, Bulpitt KJ, Hazleman BL, Urowitz MB, Sturrock RD, Coblyn JS, Maier AL, Spreen WR, Manna VK, et al.

Arthritis Rheum. 1995 Nov;38(11):1589-94.


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