A large-scale, placebo-controlled, dose-ranging trial of peroral valaciclovir for episodic treatment of recurrent herpes genitalis

Archives of Internal Medicine

Volumn 156, Issue 15, 1996, Pages 1729-1735

  Spruance, Spotswood L ^a,f   Tyring, Stephen K ^b   DeGregorio, Barry ^c   Miller, Cheryl ^d   Beutner, Karl ^e  

^a UNIVERSITY OF UTAH   (United States)

^b UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^c OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^d Deaconess Family Medicine   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; PLACEBO; VALACICLOVIR;

ADULT; AGED; ANTIVIRAL ACTIVITY; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; FEMALE; GASTROINTESTINAL TOXICITY; GENITAL HERPES; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PAIN; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; VERTIGO; VIRUS SHEDDING;

ACYCLOVIR; ADMINISTRATION, ORAL; ADULT; AGED; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; FEMALE; HERPES GENITALIS; HUMANS; MALE; MIDDLE AGED; RECURRENCE; TIME FACTORS; TREATMENT OUTCOME; VALINE;

EID: 0029798884     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.156.15.1729     Document Type: Article

References (32)

1. Nahmias AJ, Lee FK. Beckman-Nahmias S. Sero-epidemiological and sociological patterns of herpes simplex virus infection in the world. Scand J Infect Dis. 1990;69:19-36.
2. Reeves WC, Corey L, Adams HG, Vontver LA, Holmes KK. Risk of recurrence after first episodes of genital herpes. N Engl J Med. 1981;305:315-319.
3. Johnson RE, Nahmias AJ, Magder LS, Lee FK, Brooks CA, Snowden CB. A seroepidemiologic survey of the prevalence of herpes simplex virus type 2 in the United States. N Engl J Med. 1989;321:7-12.
4. Koutsky LA, Stevens CE, Holmes KK, et al. Underdiagnosis of genital herpes by current clinical and viral-isolation procedures. N Engl J Med. 1992;326: 1533-1539.
5. Langenberg A, Benedetti J, Jenkins J, Ashley R, Winter C, Corey L. Development of clinically recognizable genital lesions among women previously identified as having asymptomatic herpes simplex virus type 2 infection. Ann Intern Med. 1989;110:882-887.
6. Douglas JM, Critchlow C, Benedetti J, et al. Double-blind study of oral acyclovir for suppression of recurrences of genital herpes simplex virus infection. N Engl J Med. 1984;310:1551-1556.
7. Mattison HR, Reichman RC, Benedetti J, et al. Double-blind, placebo-controlled trial comparing long-term suppressive with short-term oral acyclovir for management of recurrent genital herpes. Am J Med. 1988;85:20-25.
8. Mostow SR, Mayfield JL, Marr J, Drucker JL. Suppression of recurrent genital herpes by single daily dosages of acyclovir. Am J Med. 1988;85:30-33.
9. Kaplowitz LG, Baker D, Gelb L, et al. Prolonged continuous acyclovir treatment of normal adults with frequently recurring genital herpes simplex virus infection. JAMA. 1991;265:747-751.
10. Corey L, Nahmias AJ, Guinan ME, Benedetti JK, Critchlow CW, Holmes KK, A trial of topical acyclovir in genital herpes simplex virus infections. N Engl J Med. 1982;2:1313-1319.
11. Reichman RC, Badger GJ, Guinan ME, et al. Topically administered acyclovir in the treatment of recurrent herpes simplex genitalis: a controlled trial. J Infect Dis. 1983;147:336-340.
12. Luby JP, Gnann JW Jr, Alexander WJ, et al. A collaborative study of patient-initiated treatment of recurrent genital herpes with topical acyclovir or placebo. J Infect Dis. 1984;150:1-6.
13. Nilsen AE, Aasen T, Halsos AM, et al. Efficacy of oral acyclovir in the treatment of initial and recurrent genital herpes. Lancet. 1982;2:571-573.
14. Reichman RC, Badger GJ, Mertz GL, Corey L, Richman DD. Treatment of recurrent genital herpes simplex infections with oral acyclovir: a controlled trial. JAMA. 1984;251:2103-2107.
15. Ruhnek-Forsbeck M, Sandstrom E, Andersson B, et al. Treatment of recurrent genital herpes simplex infections with oral acyclovir. J Antimicrob Chemother. 1985;16:621-628.
16. Goldberg LH, Kaufman R, Conant MA, et al. Oral acyclovir for episodic treatment of recurrent genital herpes. J Am Acad Dermatol. 1986;15:256-264.
17. Whitley RJ, Gnann JW. Acyclovir: a decade later. N Engl J Med. 1992;327: 782-789.
18. Mindel A. Is it meaningful to treat patients with recurrent herpetic infections? Scand J Infect Dis. 1991;78:27-32.
19. Kroon S. Genital herpes: when and how to treat. Semin Dermatol. 1990;9:133-140.
20. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines. MMWR Morb Mortal Wkly Rep. 1993;42:22-26.
21. deMiranda P, Blum MR. Pharmacokinetics of acyclovir after intravenous and oral administration. J Antimicrob Chemother. 1983;12:29-37.
22. Burnette TC, deMiranda P. Metabolic disposition of BW256U87, the L-valyl ester of acyclovir, in the rat. Antiviral Res. 1992;17(suppl 1):118. Abstract.
23. Weller S, Blum MR, Doucette M. Pharmokinetics of the acyclovir prodrug, valaciclovir, after escalating single and multiple-dose administration to normal volunteers. Clin Pharmacol Ther 1993;54:595-605.
24. Smiley ML. Valaciclovir and acyclovir for the treatment of recurrent genital herpes simplex virus infections, Intersci Conf Antimicrob Agents Chemother. 1993;33:340. Abstract.
25. Ashley R, Cent A, Maggs V, Nahmias A, Corey L. Inability of enzyme immunoassays to discriminate between infections with herpes simplex virus types 1 and 2. Ann Intern Med. 1991;115:520-526.
26. Spruance SL, Wenerstrom G. Pathogenesis of herpes simplex labialis, IV: maturation of lesions within 8 hours after onset and implications for antiviral treatment. Oral Surg Oral Med Oral Pathol. 1984;58:667-671.
27. Spruance SL, Stewart JCB, Freeman DJ, et al. Early application of topical 15% idoxuridine in dimethyl sulfoxide shortens the course of herpes simplex labialis: a multicenter placebo-controlled trial. J Infect Dis. 1990;161:191-197.
28. Spruance SL, Stewart JCB, Rowe NH, McKeough MB, Wenerstrom G, Freeman DJ. Treatment of recurrent herpes simplex labialis with oral acyclovir. J Infect Dis. 1990;161:185-190.
29. Sacks SL, Aoki FY, Diaz-Mitoma F, et al. Patient-initiated treatment of recurrent genital herpes with oral famciclovir: a Canadian, multicenter, placebo-controlled, dose-ranging study, Intersci Conf Antimicrob Agents Chemother. 1994;34:11. Abstract.
30. Spruance SL, Freeman DJ. Topical treatment of cutaneous herpes simplex virus infections. Antiviral Res. 1990;14:305-321.
31. McLaren C, Sibrack CD, Barry DW. Spectrum of sensitivity to acyclovir of herpes simplex virus clinical isolates. Am J Med. 1982;73(suppl 1A):376-379.
32. Wald A, Benedetti J, Davis G, Remington M, Winter C, Corey L. A randomized double-blind comparative trial comparing high- and standard-dose oral acyclovir for first-episode genital herpes infections. Antimicrob Agents Chemother. 1994;38:174-176.