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Antimicrobial Agents and Chemotherapy, October 2002, p. 3243-3248, Vol. 46, No. 10
0066-4804/02/$04.00+0     DOI: 10.1128/AAC.46.10.3243-3248.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Imiquimod 5-Percent Cream Does Not Alter the Natural History of Recurrent Herpes Genitalis: a Phase II, Randomized, Double-Blind, Placebo-Controlled Study

Timothy W. Schacker,1* Marcus Conant,2 Christopher Thoming,3 Tamara Stanczak,4 Zengri Wang,4 Michael Smith,4 and the Imiquimod HSV Study Group{dagger}

University of Minnesota, Minneapolis, Minnesota,1 University of California, San Francisco, San Francisco, California,2 Westover Heights Clinic, Portland, Oregon,3 3M Pharmaceuticals, St. Paul, Minnesota4

Received 26 December 2001/ Returned for modification 27 March 2002/ Accepted 3 June 2002

Present strategies for control of herpes genitalis recurrences require multiple daily doses of antiviral medication. Imiquimod, an immune response modifier, induces alpha interferon and interleukin-12; application in the presence of local herpes antigens during a recurrence may augment herpes simplex virus (HSV)-specific cell-mediated immunity. To test this theory, we performed a randomized, double-blind, placebo-controlled study of imiquimod 5% cream to assess safety and efficacy for decreasing recurrences. Patients with six or more recurrences of herpes genitalis per year applied study cream (imiquimod or placebo) to lesions one, two, or three times per week for 3 weeks for each recurrence during a 16-week treatment period. This was followed by a 16-week observation period. Of 124 patients randomized to the study, 103 completed the treatment period and 93 completed the observation period. The median times to first genital herpes recurrence were 53 days for those receiving placebo (n = 30) and 54, 60, and 64 days for those receiving imiquimod one time per week (n = 34), two times per week (n = 32), and three times per week (n = 28), respectively. The median annualized recurrence rates during the treatment period were 3.8, 4.9, 3.2, and 3.1, respectively. There were no statistically significant differences in the time to first recurrence or in the annualized recurrence rate between the imiquimod and placebo groups in either the treatment or the observation period. A trend in increased rates of local adverse events at the application site and a delay in lesion healing with more frequent dosing suggested a pharmacologic effect. Although clinical efficacy has been observed for imiquimod in other conditions in which a TH1-type immune response may be beneficial, including other viral infections such as those caused by human papillomavirus, no apparent effect on the short-term natural history of herpes genitalis recurrences was observed.

* Corresponding author. Mailing address: Division of Infectious Disease, University of Minnesota, P.O. Box 250, 215 Delaware St., Minneapolis, MN 55455. Phone: (612) 624-9955. Fax: (612) 625-4410. E-mail: schacker{at}mail.ahc.umn.edu.

{dagger} Members of the Imiquimod Herpes Simplex Virus (1330-IMIQ) Study Group follow: Timothy Schacker, University of Minnesota, Minneapolis, Minn.; Karl Beutner, Solano Dermatology Associates, Vallejo, Calif.; Marcus Conant, University of California San Francisco, San Francisco, Calif.; Kenneth Fife, Indiana University Medical School, Indianapolis, Ind.; Harold Guy, Institute of Healthcare Assessment, Inc., San Diego, Calif.; Charles Livengood, Duke University Medical Center, Durham, N.C.; Christopher Thoming, Westover Heights Clinic, Portland, Oreg.; and T. Stanczak, S. Parrish, M. Markert, Z. Wang, S. Hannon, M. Smith, C. Christiansen, M. Klebe, B. Farladeaux, A. Edgren, and T. C. Meng, 3M Pharmaceuticals, St. Paul, Minn.

Antimicrobial Agents and Chemotherapy, October 2002, p. 3243-3248, Vol. 46, No. 10
0066-4804/02/$04.00+0     DOI: 10.1128/AAC.46.10.3243-3248.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Herbst, M. M., Pyles, R. B. (2003). Immunostimulatory CpG treatment for genital HSV-2 infections. J Antimicrob Chemother 52: 887-889 [Full Text]  


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