Document Detail

Effect of resiquimod 0.01% gel on lesion healing and viral shedding when applied to genital herpes lesions.
MedLine Citation:
PMID:  18039918     Owner:  NLM     Status:  MEDLINE    
Resiquimod, a Toll-like receptor 7/8 agonist developed as a topical treatment to decrease recurrences of anogenital herpes, induces proinflammatory cytokines that may delay lesion healing. Adults with frequently recurring anogenital herpes were randomized within 24 h of onset of a recurrence to vehicle or resiquimod 0.01% gel two times per week for 3 weeks. Subjects underwent daily lesion assessments and sampling for herpes simplex virus DNA PCR for 21 days or until investigator-determined healing of lesion(s). Eighty-two subjects with a mean age of 39 +/- 10.5 years and a median of seven recurrences per year were enrolled in the study. The qualifying recurrence was positive by PCR for herpes simplex virus in 68% of subjects. No difference was observed between the vehicle (39 subjects) and resiquimod (43 subjects) groups with respect to time to healing (median of 7.0 days versus median of 6.5 days, respectively; Cox proportional hazard model ratio of 1.229; 95% confidence interval, 0.778 to 1.942; P = 0.376). The distributions of maximum severity scores for any investigator-assessed local skin signs and for subject-assessed local symptoms were similar between treatment groups (P = 0.807 and P = 0.103, respectively). For subjects with at least one positive PCR result, no difference was observed for time to cessation of viral shedding (median of 7 days versus median of 5 days for vehicle and resiquimod groups, respectively; Cox proportional hazard model ratio of 1.471; 95% confidence interval, 0.786 to 2.754; P = 0.227). Application of resiquimod 0.01% two times per week for 3 weeks did not delay the healing of genital herpes lesions or reduce acute viral shedding.
Kenneth H Fife; Tze-Chiang Meng; Daron G Ferris; Ping Liu
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-11-26
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  52     ISSN:  0066-4804     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2008-01-24     Completed Date:  2008-04-29     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  477-82     Citation Subset:  IM    
Division of Infectious Diseases, Departmernt of Medicine, Indiana University School of Medicine, Emerson Hall 435, 545 Barnhill Drive, Indianapolis, IN 46202, USA.
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MeSH Terms
Administration, Topical
Antiviral Agents* / administration & dosage,  pharmacology,  therapeutic use
Double-Blind Method
Herpes Genitalis / drug therapy*,  virology
Herpesvirus 2, Human / drug effects,  genetics,  isolation & purification,  physiology
Imidazoles* / administration & dosage,  pharmacology,  therapeutic use
Middle Aged
Proportional Hazards Models
Time Factors
Treatment Outcome
Virus Shedding / drug effects*
Wound Healing / drug effects*
Reg. No./Substance:
0/Antiviral Agents; 0/Imidazoles; 0/R 848

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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