Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers

Antimicrobial Agents and Chemotherapy

Volumn 54, Issue 12, 2010, Pages 4999-5003

  Kiser, Jennifer J ^a   Bumpass, J Brock ^a,b   Meditz, Amie L ^a   Anderson, Peter L ^a   Bushman, Lane ^a   Ray, Michelle ^a   Predhomme, Julie A ^a   Rower, Joseph ^a   MaWhinney, Sam ^a   Brundage, Richard ^c  

^a UNIVERSITY OF COLORADO   (United States)

^b CAMPBELL UNIVERSITY   (United States)

^c UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM MAGNESIUM HYDROXIDE; RALTEGRAVIR;

ADULT; AREA UNDER THE CURVE; ARTICLE; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN EXPERIMENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE;

ADOLESCENT; ADULT; ANTACIDS; ANTI-RETROVIRAL AGENTS; DRUG INTERACTIONS; FEMALE; HIV SERONEGATIVITY; HUMANS; MALE; MIDDLE AGED; PYRROLIDINONES; YOUNG ADULT;

EID: 78649681819     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00636-10     Document Type: Article

References (21)

1. Bumpass, J. B., R. Brundage, A. Meditz, P. L. Anderson, L. Bushman, M. Ray, J. Predhomme, S. MaWhinney, and J. J. Kiser. 2010. Abstr. 50th Intersci. Conf. Antimicrob. Agents Chemother., Boston, MA, poster A1-2013.
2. Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health. 2004. Division of AIDS table for grading the severity of adult and pediatric adverse events. National Institutes of Health, Bethesda, MD.
3. Fayet-Mello, A., T. Buclin, C. Franc, S. Colombo, S. Cruchon, N. Guignard, J. Biollaz, A. Telenti, L. A. Decosterd, and M. Cavassini. 2010. Intracellular and plasma pharmacokinetics of raltegravir in HIV-infected patients, abstr. 614. Abstr. 17th Conf. Retrovir. Oppor. Infect., San Francisco, CA, 16 to 19 February 2010.
4. Grinsztejn, B., B. Y. Nguyen, C. Katlama, J. M. Gatell, A. Lazzarin, D. Vittecoq, C. J. Gonzalez, J. Chen, C. M. Harvey, and R. D. Isaacs. 2007. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet 369:1261-1269.
5. Hazuda, D., M. Iwamoto, and L. Wenning. 2009. Emerging pharmacology: inhibitors of human immunodeficiency virus integration. Annu. Rev. Pharmacol. Toxicol. 49:377-394.
6. Iwamoto, M., L. A. Wenning, B. Y. Nguyen, H. Teppler, A. R. Moreau, R. R. Rhodes, W. D. Hanley, B. Jin, C. M. Harvey, S. A. Breidinger, N. Azrolan, H. F. Farmer, Jr., R. D. Isaacs, J. A. Chodakewitz, J. A. Stone, and J. A. Wagner. 2009. Effects of omeprazole on plasma levels of raltegravir. Clin. Infect. Dis. 48:489-492.
7. Iwamoto, M., L. A. Wenning, A. S. Petry, M. Laethem, M. De Smet, J. T. Kost, S. A. Merschman, K. M. Strohmaier, S. Ramael, K. C. Lasseter, J. A. Stone, K. M. Gottesdiener, and J. A. Wagner. 2008. Safety, tolerability, and pharmacokinetics of raltegravir after single and multiple doses in healthy subjects. Clin. Pharmacol. Ther. 83:293-299.
8. Reference deleted.
9. Lennox, J. L., E. DeJesus, A. Lazzarin, R. B. Pollard, J. V. Madruga, D. S. Berger, J. Zhao, X. Xu, A. Williams-Diaz, A. J. Rodgers, R. J. Barnard, M. D. Miller, M. J. DiNubile, B. Y. Nguyen, R. Leavitt, and P. Sklar. 2009. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet 374:796-806.
10. Luber, A., V. Garg, S. Gharakhanian, and the Vertex HIV Program Team. 2004. Survey of medication used by HIV-infected patients that affect gastrointestinal (GI) acidity and potential for negative drug interactions with HAART, abstr. 206. Abstr. 7th Int. Conf. Drug Ther. HIV Infect., Glasgow, United Kingdom, 14 to 18 November 2008.
11. Markowitz, M., J. O. Morales-Ramirez, B. Y. Nguyen, C. M. Kovacs, R. T. Steigbigel, D. A. Cooper, R. Liporace, R. Schwartz, R. Isaacs, L. R. Gilde, L. Wenning, J. Zhao, and H. Teppler. 2006. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J. Acquir. Immune Defic. Syndr. 43:509-515.
12. Merck. 2010. Isentress product information. Merck and Co., Whitehouse Station, NJ.
13. Merschman, S. A., P. T. Vallano, L. A. Wenning, B. K. Matuszewski, and E. J. Woolf. 2007. Determination of the HIV integrase inhibitor, MK-0518 (raltegravir), in human plasma using 96-well liquid-liquid extraction and HPLC-MS/MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 857:15-24.
14. Ramanathan, S., G. Shen, J. Hinkle, J. Enejosa, and B. P. Kearney. 2007. Pharmacokinetic evaluation of drug interactions with ritonavir-boosted HIV integrase inhibitor GS-9137 (elvitegravir) and acid-reducing agents, abstr. 69. Eighth Int. Workshop Clin. Pharmacol. HIV Ther., Budapest, Hungary, 16 to 18 April 2007.
15. Song, I., A. Patel, S. Min, Y. Lou, S. Chen, P. Patel, T. Wajima, and S. Piscitelli. 2009. Evaluation of antacid and multivitamin (MVI) effects on S/GSK1349572 pharmacokinetics in healthy subjects, abstr. A1-1305. Abstr. 49th Intersci. Conf. Antimicrob. Agents Chemother.
16. Steigbigel, R. T., D. A. Cooper, P. N. Kumar, J. E. Eron, M. Schechter, M. Markowitz, M. R. Loutfy, J. L. Lennox, J. M. Gatell, J. K. Rockstroh, C. Katlama, P. Yeni, A. Lazzarin, B. Clotet, J. Zhao, J. Chen, D. M. Ryan, R. R. Rhodes, J. A. Killar, L. R. Gilde, K. M. Strohmaier, A. R. Meibohm, M. D. Miller, D. J. Hazuda, M. L. Nessly, M. J. DiNubile, R. D. Isaacs, B. Y. Nguyen, and H. Teppler. 2008. Raltegravir with optimized background therapy for resistant HIV-1 infection. N. Engl. J. Med. 359:339-354.
17. U. S. Department of Health and Human Services. 2009. Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. Department of Health and Human Services, Washington, DC. http://www.aidsinfo. nih.gov/Contentfiles/AdultandAdolescentGL.pdf.
18. van Lunzen, J., H. Liess, K. Arasteh, R. Walli, B. Daut, and D. Schurmann. 2007. Concomitant use of gastric acid-reducing agents is frequent among HIV-1-infected patients receiving protease inhibitor-based highly active antiretroviral therapy. HIV Med. 8:220-225.
19. Weng, Q., R. Kulaway, J. J. McSharry, and G. L. Drusano. 2009. Dose range and dose fractionation studies for raltegravir pharmacodynamics in an in vitro hollow fiber model infection system, abstr. O-09. Tenth Int. Workshop Clin. Pharmacol. HIV Ther., Amsterdam, Netherlands, 15 to 17 April 2009.
20. Wenning, L., E. Hwang, B.-Y. Nguyen, H. Teppler, R. Danovich, M. Iwamoto, J. A. Wagner, D. Panebianco, and J. Stone. 2008. Pharmacokinetic/ pharmacodynamic (PK/PD) analyses for raltegravir (RAL) in phase III studies in treatment-experienced HIV-infected patients following 48 weeks of treatment, abstr. H-4054. Abstr. 48th Annu. Intersci. Conf. Antimicrob. Agents Chemother. (ICAAC)-Infect. Dis. Soc. Am. (IDSA) 46th Annu. Meet. American Society for Microbiology and Infectious Diseases Society of America, Washington, DC.
21. Wenning, L. A., B. Y. Nguyen, X. Sun, E. Hwang, Y. Chen, H. Teppler, C. Harvey, R. Rhodes, D. Ryan, N. Azrolan, and J. Stone. 2008. Pharmacokinetic/ pharmacodynamic (PK/PD) analyses for raltegravir in phase II and III studies in treatment experienced HIV-infected patients, abstr. 021. Ninth Int. Workshop Clin. Pharmacol. HIV Ther., New Orleans, LA, 8 to 10 April 2008.