High-dose, short-duration, early valacyclovir therapy for episodic treatment of cold sores: Results of two randomized, placebo-controlled, multicenter studies

Antimicrobial Agents and Chemotherapy

Volumn 47, Issue 3, 2003, Pages 1072-1080

  Spruance, Spotswood L ^a,e   Jones, Terry M ^b   Blatter, Mark M ^c   Vargas Cortes, Mauricio ^d   Barber, Judy ^o   Hill, Joanne ^o   Goldstein, Donna ^d   Schultz, Margaret ^d   Block Jr , S L ^f   Davis, M G ^g   Furst, B ^h   Kutcher, M ⁱ   Lapidus, R ^j   Larsen, L V ^k   Lassonde, M G ^o   Marbury, T C ^l   Powers, J L ^m   Tyring, S K ⁿ  

^a UNIVERSITY OF UTAH   (United States)

^b J and S Studies   (United States)

^c Primary Physicians Research   (United States)

^d GLAXOSMITHKLINE   (United States)

^e UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^f Kentucky Pediatric Research Institute   (United States)

^g Rochester Clinical Research   (United States)

^h CALIFORNIA STATE UNIVERSITY   (United States)

ⁱ UNIVERSITY OF NORTH CAROLINA   (United States)

^j Rocky Mountain Center for Clinical Research   (United States)

^k Intermountain Clinical Research   (United States)

^l ORLANDO CLINICAL RESEARCH CENTER   (United States)

^m RADIANT RESEARCH   (United States)

ⁿ CENTER FOR CLINICAL STUDIES   (United States)

^o NONE

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; PLACEBO; VALACICLOVIR;

ADOLESCENT; ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; FEMALE; FLATULENCE; HEADACHE; HERPES LABIALIS; HERPES SIMPLEX VIRUS 1; HUMAN; MAJOR CLINICAL STUDY; MALE; META ANALYSIS; NAUSEA; NONHUMAN; PAIN ASSESSMENT; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TIME SERIES ANALYSIS; XEROSTOMIA;

ACYCLOVIR; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; CHILD; DOUBLE-BLIND METHOD; FEMALE; HERPES LABIALIS; HUMANS; MALE; MIDDLE AGED; PAIN; VALINE;

EID: 0037416977     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.47.3.1072-1080.2003     Document Type: Article

References (25)

1. Awan, A. R., J. Harmenberg, O. Flink, and H. J. Field. 1998. Combinations of antiviral and anti-inflammatory preparations for the topical treatment of herpes simplex virus assessed using a murine zosteriform infection model. Antivir. Chem. Chemother. 9:19-24.
2. Bader, C., S. C. Crumpacker, L. E. Schnipper, B. Ransil, J. E. Clark, K. Arndt, and I. M. Freedberg. 1978. The natural history of recurrent facial-oral infection with herpes simplex virus. J. Infect. Dis. 138:897-905.
3. Beauchamp, L. M., and T. A. Krenitsky. 1993. Acyclovir prodrugs: the road to valaciclovir. Drugs Future 18:619-628.
4. Efron, B., and R. J. Tibshirani. 1993. An introduction to the bootstrap. Chapman and Hall, New York, N.Y.
5. Embil, J. A., R. G. Stephens, and F. R. Manual. 1975. Prevalence of recurrent herpes labialis and aphthous ulcers among young adults on six continents. Can. Med. Assoc. J. 113:627-630.
6. Fiddian, A. P., J. M. Yeo, R. Stubbings, and D. Dean. 1983. Successful treatment of herpes labialis with topical acyclovir. Br. Med. J. 286:1699-1701.
7. Fleiss, J. L. 1981. Statistical methods for rates and proportions. John Wiley & Sons, New York, N.Y.
8. Hochberg, Y., and Y. Benjamini. 1990. More powerful procedures for multiple significance testing. Stat. Med. 9:811-818.
9. Huff, J. C., G. G. Krueger, J. C. Overall, J. Copeland, and S. L. Spruance. 1981. The histopathologic evolution of recurrent herpes simplex labialis. J. Am. Acad. Dermatol. 5:550-557.
10. Lehman, E. L. 1975. Nonparametrics: statistical methods based on ranks. Holden-Day, Inc., San Francisco, Calif.
11. McKeough, M. B., and S. L. Spruance. 2001. Comparison of new topical treatments for herpes labialis: efficacy of penciclovir cream, acyclovir cream, and n-docosanol cream against experimental cutaneous herpes simplex virus type 1 infection. Arch. Dermatol. 137:1153-1158.
12. Notkins, A. L., R. A. Bankowski, S. Baron, E. A. Graykowski, R. C. Greulich, M. R. Hilleman, A. S. Kaplan, H. E. Kaufman, S. J. Kreshover, E. H. Lennette, A. M. Lerner, A. J. Nahmias, F. P. Peck, Jr., S. A. Plotkin, F. Rapp, B. Roizman, R. J. Schnellin, and J. L. Sever. 1973. Workshop on the treatment and prevention of herpes simplex virus infections. J. Infect. Dis. 127:117-119.
13. Raborn, G. W., A. Y. Martel, et al. 2002. Effective treatment of herpes simplex labialis with penciclovir cream: combined results of two trials. J. Am. Dent. Assoc. 133:303-309.
14. Raborn, G. W., W. T. McGaw, M. Grace, D. Tyrrell, and S. M. Samuels. 1987. Oral acyclovir and herpes labialis: a randomized, double-blind, placebo-controlled study. J. Am. Dent. Assoc. 115:38-42.
15. Sacks, S. L., R. A. Thisten, T. M. Jones, et al. 2001. Clinical efficacy of topical docosanol 105 cream for herpes simplex labialis: a multicenter, randomized, placebo-controlled trial. J. Am. Acad. Dermatol. 45:222-230.
16. Shelley, W. B., and E. D. Shelley. 1996. Single dose of acyclovir for prevention of herpes simplex. Ther. Clin. 57:453.
17. Soul-Lawton, J., E. Seaber, N. On, et al. 1995. Absolute bioavailability and metabolic disposition of valacyclovir, the L-valyl ester of acyclovir, following oral administration in humans. Antimicrob. Agents Chemother. 39:2759-2764.
18. Spruance, S. L. 1995. Herpes simplex labialis, p. 3-45. In S. L. Sacks, S. E. Strauss, R. J. Whitley, P. D. Griffiths (ed.), Clinical management of herpes viruses. IOS Press, Amsterdam, The Netherlands.
19. Spruance, S. L., R. Nett, T. Marbury, R. Wolff, J. Johnson, and T. Spaulding. 2002. Acyclovir cream for the treatment of herpes simplex labialis: the results of two randomized, double-blind, vehicle-controlled clinical trials. Antimicrob. Agents Chemother. 46:2238-2243.
20. Spruance, S. L., T. L. Rea, C. Thoming, R. Tucker, R. Saltzman, and R. Boon. 1997. Penciclovir cream for the treatment of herpes simplex labialis: a randomized, multicenter, double-blind, placebo-controlled trial. JAMA 277:1374-1379.
21. Spruance, S. L., J. C. B. Stewart, N. H. Rowe, M. B. McKeough, G. Wenerstrom, and D. J. Freeman. 1990. Treatment of recurrent herpes simplex labialis with oral acyclovir. J. Infect. Dis. 161:185-190.
22. Spruance, S. L., and G. Wenerstrom. 1984. Pathogenesis of recurrent herpes simplex labialis, IV: maturation of lesions within 8 hours after onset and implications for antiviral treatment. Oral Surg. Oral Med. Oral Pathol. 58:667-671.
23. Vander Straten, M., D. Carrasco, P. Lee, and S. K. Tyring. 2001. A review of antiviral therapy for herpes labialis. Arch. Dermatol. 137:1232-1235.
24. Weller, S., M. R. Blum, M. Doucette, T. Burnette, D. M. Cederberg, P. de Miranda, and M. L. Smiley. 1993. Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Clin. Pharm. Ther. 54:595-605.
25. Young, S. K., N. H. Rowe, and R. A. Buchanan. 1976. A clinical study for the control of facial mucocutaneous herpes virus infections: characterization of natural history in a professional school population. Oral Surg. 41:498-507.