Safety and pharmacokinetics of aciclovir in women following release from a silicone elastomer vaginal ring

Journal of Antimicrobial Chemotherapy

Volumn 67, Issue 8, 2012, Pages 2005-2012

  Keller, M J ^a   Malone, A M ^b   Carpenter, C A ^a   Lo, Y ^a   Huang, M ^c   Corey, L ^c   Willis, R ^b   Nguyen, C ^b   Kennedy, S ^d   Gunawardana, M ^b,d   Guerrero, D ^e   Moss, J A ^d   Baum, M M ^d   Smith, T J ^b   Herold, B C ^a  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b Auritec Pharmaceuticals Inc   (United States)

^c Fred Hutchinson Cancer Research Center   (United States)

^d OAK CREST INSTITUTE OF SCIENCE   (United States)

^e HOUSE RESEARCH INSTITUTE   (United States)

Author keywords

Genital herpes; Herpes simplex virus; Vaginal microbicides

Indexed keywords

ACICLOVIR; SILASTIC; VALACICLOVIR; VIRUS DNA;

ADULT; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GENITAL HERPES; HUMAN; POLYMERASE CHAIN REACTION; VAGINA RING; VAGINAL LAVAGE; VIRUS SHEDDING;

ACYCLOVIR; ADULT; ANTIVIRAL AGENTS; CONTRACEPTIVE DEVICES, FEMALE; DRUG CARRIERS; FEMALE; HERPES GENITALIS; HUMANS; MIDDLE AGED; MUCOUS MEMBRANE; PLASMA; SILICONE ELASTOMERS; VAGINA;

EID: 84862858373     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dks151     Document Type: Article

References (25)

1. Looker KJ, Garnett GP, Schmid GP. An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection. Bull World Health Organ 2008; 86: 805-12, A.
2. Corey L, Wald A, Patel R et al. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N Engl J Med 2004; 350: 11-20.
3. Aoki FY, Tyring S, Diaz-Mitoma F et al. Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis 2006; 42: 8-13.
4. Tronstein E, Johnston C, Huang ML et al. Genital shedding of herpes simplex virus among symptomatic and asymptomatic persons with HSV-2 infection. JAMA 2011; 305: 1441-9.
5. Mertz GJ. Asymptomatic shedding of herpes simplex virus 1 and 2: implications for prevention of transmission. J Infect Dis 2008; 198: 1098-100.
6. Freeman EE, Weiss HA, Glynn JR et al. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS 2006; 20: 73-83.
7. Patel R, Bodsworth NJ, Woolley P et al. Valaciclovir for the suppression of recurrent genital HSV infection: a placebo controlled study of once daily therapy. International Valaciclovir HSV Study Group. Genitourin Med 1997; 73: 105-9.
8. 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.
9. Andrei G, Lisco A, Vanpouille C et al. Topical tenofovir, a microbicide effective against HIV, inhibits herpes simplex virus-2 replication. Cell Host Microbe 2011; 10: 379-89.
10. Corey L, Benedetti JK, Critchlow CWet al. Double-blind controlled trial of topical acyclovir in genital herpes simplex virus infections. Am J Med 1982; 73: 326-34.
11. Corey L, Nahmias AJ, Guinan ME et al. A trial of topical acyclovir in genital herpes simplex virus infections. N Engl J Med 1982; 306: 1313-9.
12. Malcolm RK, Edwards KL, Kiser P et al. Advances in microbicide vaginal rings. Antiviral Res 2010; 88 Suppl 1: S30-9.
13. Moss JA, Baum MM, Malone AM et al. Tenofovir and tenofovir disoproxil fumarate pharmacokinetics from intravaginal rings. AIDS 2012; 26: 707-10.
14. Moss JA, Malone AM, Smith TJ et al. Simultaneous delivery of tenofovir and acyclovir via an intravaginal ring. Antimicrob Agents Chemother 2012; 56: 875-82.
15. Jerome KR, Huang ML, Wald A et al. Quantitative stability of DNA after extended storage of clinical specimens as determined by real-time PCR. J Clin Microbiol 2002; 40: 2609-11.
16. Webster P, Wu S, Webster S et al. Ultrastructural preservation of biofilms formed by non-typeable Haemophilus influenzae. Biofilms 2004; 1: 165-82.
17. Gunawardana M, Moss JA, Smith TJ et al. Microbial biofilms on the surface of intravaginal rings worn in non-human primates. J Med Microbiol 2011; 60: 828-37.
18. John M, Keller MJ, Fam EH et al. Cervicovaginal secretions contribute to innate resistance to herpes simplex virus infection. J Infect Dis 2005; 192: 1731-40.
19. Shust GF, Cho S, Kim M et al. Female genital tract secretions inhibit herpes simplex virus infection: correlation with soluble mucosal immune mediators and impact of hormonal contraception. Am J Reprod Immunol 2010; 63: 110-9.
20. Van Dyke RB, Connor JD, Wyborny C et al. Pharmacokinetics of orally administered acyclovir in patients with herpes progenitalis. Am J Med 1982; 73: 172-5.
21. Thurman AR, Clark MR, Doncel GF. Multipurpose prevention technologies: biomedical tools to prevent HIV-1, HSV-2, and unintended pregnancies. Infect Dis Obstet Gynecol 2011; 2011: 1-10.
22. Belec L, Meillet D, Levy M et al. Dilution assessment of cervicovaginal secretions obtained by vaginal washing for immunological assays. Clin Diagn Lab Immunol 1995; 2: 57-61.
23. Dezzutti CS, Hendrix CW, Marrazzo JM et al. Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators. PLoS One 2011; 6: e23136.
24. Mitchell C, Paul K, Agnew K et al. Estimating volume of cervicovaginal secretions in cervicovaginal lavage fluid collected for measurement of genital HIV-1 RNA levels in women. J Clin Microbiol 2011; 49: 735-6.
25. O'Toole G, Kaplan HB, Kolter R. Biofilm formation as microbial development. Annu Rev Microbiol 2000; 54: 49-79.