title: Evaluation of new anti-infective drugs for the treatment of genital infections due to herpes simplex virus. Infectious Diseases Society of America and the Food and Drug Administration.
abstract: This guideline addresses clinical trials of new therapies for genital infections due to herpes simplex virus (HSV). Of the two types of virus, HSV-2 is the more common pathogen. Both HSV-1 and HSV-2 become latent in sacral nerve root ganglia and intermittently reactivate. Patients who have frequent recurrences (more than four per year) may be candidates for long-term suppressive therapy. In both first-episode and recurrent genital HSV infections, lesions should be cultured for HSV. Testing for human immunodeficiency virus is encouraged but not required. Serum antibodies to HSV-1 and HSV-2 should be quantitated at enrollment and 3-5 weeks thereafter. Randomized, double-blind, active-control comparative studies are generally recommended. Placebo-controlled trials may be appropriate for recurrent genital herpes or for suppression of recurrences. Final evaluation should generally take place 10-15 days after the completion of therapy.
authors: Department of Medicine, University of Washington School of Medicine, Seattle.
authors: L
authors: L
authors: Corey
authors: J A
authors: JA
authors: McCutchan
authors: A R
authors: AR
authors: Ronald
authors: H H
authors: HH
authors: Handsfield
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D017321:Clinical Trials, Phase I as Topic / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D005260:Female; D006558:Herpes Genitalis / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male
chemical_list: D000890:Anti-Infective Agents