Measurement of Plasma and Intracellular Concentrations of Raltegravir

Summary

The primary purpose of this study is to analyze and compare plasma and intracellular concentrations of Raltegravir (RAL) in blood plasma and in peripheral blood mononuclear cells, using high performance liquid chromatography (HPLC).

Timeline

Start

2010-10-01

Primary completion

2011-04-30

Completion

2011-06-30

Publications

• Background Thompson MA, Aberg JA, Cahn P, Montaner JS, Rizzardini G, Telenti A, Gatell JM, Gunthard HF, Hammer SM, Hirsch MS, Jacobsen DM, Reiss P, Richman DD, Volberding PA, Yeni P, Schooley RT; International AIDS Society-USA. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the International AIDS Society-USA panel. JAMA. 2010 Jul 21;304(3):321-33. doi: 10.1001/jama.2010.1004.
• Background Hicks C, Gulick RM. Raltegravir: the first HIV type 1 integrase inhibitor. Clin Infect Dis. 2009 Apr 1;48(7):931-9. doi: 10.1086/597290.
• Background 3. http://www.merck.com/product/usa/pi_circulars/i/isentress/isentress_pi.pdf
• Background de Maat MM, Huitema AD, Mulder JW, Meenhorst PL, van Gorp EC, Mairuhu AT, Beijnen JH. Subtherapeutic antiretroviral plasma concentrations in routine clinical outpatient HIV care. Ther Drug Monit. 2003 Jun;25(3):367-73. doi: 10.1097/00007691-200306000-00018.
• Background Powderly WG, Saag MS, Chapman S, Yu G, Quart B, Clendeninn NJ. Predictors of optimal virological response to potent antiretroviral therapy. AIDS. 1999 Oct 1;13(14):1873-80. doi: 10.1097/00002030-199910010-00009.
• Background Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A. Bioanalytical method validation--a revisit with a decade of progress. Pharm Res. 2000 Dec;17(12):1551-7. doi: 10.1023/a:1007669411738. No abstract available.
• Background Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, Weiner R. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm Res. 2007 Oct;24(10):1962-73. doi: 10.1007/s11095-007-9291-7. Epub 2007 Apr 26.
• Background King T, Bushman L, Anderson PL, Delahunty T, Ray M, Fletcher CV. Quantitation of zidovudine triphosphate concentrations from human peripheral blood mononuclear cells by anion exchange solid phase extraction and liquid chromatography-tandem mass spectroscopy; an indirect quantitation methodology. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Feb 2;831(1-2):248-57. doi: 10.1016/j.jchromb.2005.12.033. Epub 2006 Jan 10.
• Background Remmel RP, Kawle SP, Weller D, Fletcher CV. Simultaneous HPLC assay for quantification of indinavir, nelfinavir, ritonavir, and saquinavir in human plasma. Clin Chem. 2000 Jan;46(1):73-81.

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Indications