Single and multiple dose pharmacokinetics of maraviroc in saliva, semen, and rectal tissue of healthy HIV-negative men

Journal of Infectious Diseases

Volumn 203, Issue 10, 2011, Pages 1484-1490

  Brown, Kevin C ^a   Patterson, Kristine B ^b   Malone, Stephanie A ^a   Shaheen, Nicholas J ^b   Prince, Heather M Asher ^b   Dumond, Julie B ^a   Spacek, Melissa B ^b   Heidt, Paris E ^b   Cohen, Myron S ^b   Kashuba, Angela D M ^a  

^a University of North Carolina   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MARAVIROC;

ACCURACY; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; PROTEIN BINDING; SALIVA ANALYSIS; SEMEN ANALYSIS; TIME TO MAXIMUM PLASMA CONCENTRATION; TISSUE DISTRIBUTION;

ADULT; ANTI-HIV AGENTS; AREA UNDER CURVE; CYCLOHEXANES; DRUG ADMINISTRATION SCHEDULE; HUMANS; MALE; RECTUM; SALIVA; SEMEN; TRIAZOLES; YOUNG ADULT;

EID: 79954988179     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jir059     Document Type: Article

References (27)

1. Division of Human Health Services: Center for Disease Control and Prevention CDC. Questions and answers: The 15% increase in HIV diagnoses from 2004-2007 in 34 states and general surveillance report questions. http://www.cdc.gov/hiv/surveillance/resources/reports/2007report/ qa/. Accessed 1 November 2010.
2. U.S. Department of Veteran Affairs VA. Prevention for Positives. http://www.hiv.va.gov/provider/manual-primary-care/prevention-forpositives. asp. Accessed 22 March 2011.
3. McGowan I. Rectal microbicides: A new focus for HIV prevention. Sex Transm Infect 2008; 84:413-7.
4. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 329:1168-74.
5. McGowan I. Microbicides for HIV prevention: Reality or hope? Curr Opin Infect Dis 2010; 23:26-31.
6. Barouch DH, Korber B. HIV-1 vaccine development after STEP. Annu Rev Med 2010; 61:153-67.
7. Chakraborty H, Sen PK, Helms RW, et al. Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: A probabilistic empiric model. AIDS 2001; 15:621-7. (Pubitemid 32281358)
8. Bujan L, Daudin M, Matsuda T, et al. Factors of intermittent HIV-1 excretion in semen and efficiency of sperm processing in obtaining spermatozoa without HIV-1 genomes. AIDS 2004; 18:757-66. (Pubitemid 38535003)
9. Cohen MS, Gay C, Kashuba AD, Blower S, Paxton L. Narrative review: Antiretroviral therapy to prevent the sexual transmission of HIV-1. Ann Intern Med 2007; 146:591-601. (Pubitemid 351650540)
10. Rakhmanina NY, Capparelli EV, van den Anker JN, et al. Nevirapine concentration in nonstimulated saliva: An alternative to plasma sampling in children with human immunodeficiency virus infection. Ther Drug Monit 2007; 29:110-7. (Pubitemid 46279884)
11. Dumond JB, Patterson KB, Pecha AL, et al. Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women. J Acquir Immune Defic Syndr 2009; 51:546-53.
12. Dorr P, Westby M, Dobbs S, et al. Maraviroc (UK-427,857), a potent, orally bioavailable, and selective small-molecule inhibitor of chemokine receptor CCR5 with broad-spectrum anti-human immunodeficiency virus type 1 activity. Antimicrob Agents Chemother 2005; 49:4721-32. (Pubitemid 41552605)
13. Abel S, van der Ryst E, Rosario MC, et al. Assessment of the pharmacokinetics, safety and tolerability of maraviroc, a novel CCR5 antagonist, in healthy volunteers. Br J Clin Pharmacol 2008; 65(Suppl 1):5-18. (Pubitemid 351366533)
14. US DHHS, FDA and CDER. Guidance for industry: Bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine, 2001. http://www.fda.gov/ Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/default htm. Accessed 1 November 2010.
15. Cao YJ, Ndovi TT, Parsons TL, Guidos AM, Caffo B, Hendrix CW. Effect of semen sampling frequency on seminal antiretroviral drug concentration. Clin Pharmacol Ther 2008; 83:848-56. (Pubitemid 351704914)
16. Mardirossian G, Tagesson M, Blanco P, et al. A new rectal model for dosimetry applications. J Nucl Med 1999; 40:1524-31. (Pubitemid 29428937)
17. Pfizer, Inc. Selzentry (Maraviroc) tablets full prescribing information. 2010. http://www.viivhealthcare.com/products/~/media/Files/G/GlaxoSmithKline- Plc/Attachments/pdfs/products/selzentry-maraviroc-tablets-5May2010.pdf. Accessed 1 November 2010.
18. Meng G, Wei X, Wu X, et al. Primary intestinal epithelial cells selectively transfer R5 HIV-1 to CCR51 cells. Nat Med 2002; 8:150-6. (Pubitemid 34155126)
19. Moore JP, Kitchen SG, Pugach P, Zack JA. The CCR5 and CXCR4 coreceptors-central to understanding the transmission and pathogenesis of human immunodeficiency virus type 1 infection. AIDS Res Hum Retroviruses 2004; 20:111-26. (Pubitemid 38147183)
20. Fletcher PS, Herrera C, Armanasco N, et al. Anti-HIV activity of the candidate microbicide maraviroc, a CCR5 receptor antagonist. In: Program and abstracts of the 5th IAS Conference on HIV Pathogenesis, Treatment andPrevention. 2009. Abstract WEPDC201.
21. Walker DK, Bowers SJ, Mitchell RJ, Potchoiba MJ, Schroeder CM, Small HF. Preclinical assessment of the distribution of maraviroc to potential human immunodeficiency virus (HIV) sanctuary sites in the central nervous system (CNS) and gut-associated lymphoid tissue (GALT). Xenobiotica 2008; 38:1330-9.
22. Khanvilkar K, Donovan MD, Flanagan DR. Drug transfer through mucus. Adv Drug Deliv Rev 2001; 48:173-93. (Pubitemid 32434402)
23. Schmelzer M, Schiller LR, Meyer R, Rugari SM, Case P. Safety and effectiveness of large-volume enema solutions. Appl Nurs Res 2004; 17:265-74. (Pubitemid 39572423)
24. Carballo-Dieguez A, Bauermeister JA, Ventuneac A, Dolezal C, Balan I, Remien RH. The use of rectal douches among HIV-uninfected and infected men who have unprotected receptive anal intercourse: Implications for rectal microbicides. AIDS Behav 2008; 12:860-6.
25. Dumond JB, Yeh RF, Patterson KB, et al. Antiretroviral drug exposure in the female genital tract: Implications for oral pre- and post-exposure prophylaxis. AIDS 2007; 21:1899-907. (Pubitemid 47329766)
26. University of Liverpool HIV Drug Interactions. Sponsored by Abbott, Gilead, and others. http://www.hiv-druginteractions.org/. Accessed 1 Novermber 2010.
27. Cao YJ, Hendrix CW. Male genital tract pharmacology: Developments in quantitative methods to better understand a complex peripheral compartment. Clin Pharmacol Ther 2008; 83:401-12. (Pubitemid 351272639)