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Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

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ClinicalTrials.gov Identifier: NCT01658826
Recruitment Status : Terminated
First Posted : August 7, 2012
Last Update Posted : September 23, 2016
Medpace, Inc.
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH

August 3, 2012
August 7, 2012
September 23, 2016
October 2012
May 2013   (Final data collection date for primary outcome measure)
Within-subject genital HSV mucocutaneous shedding rate: number of HSV positive swabs per subject relative to the total number of swabs collected per subject. [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT01658826 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.
The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Genital Herpes
  • Drug: AIC316
    oral administration
  • Drug: Valacyclovir
    oral administration
  • Experimental: AIC316
    100 mg once daily for 28 days
    Intervention: Drug: AIC316
  • Active Comparator: Valacyclovir
    500 mg once daily for 28 days
    Intervention: Drug: Valacyclovir
Wald A, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Fife K, Selke S, Huang ML, Stobernack HP, Zimmermann H, Corey L, Birkmann A, Ruebsamen-Schaeff H. Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences: A Randomized Clinical Trial. JAMA. 2016 Dec 20;316(23):2495-2503. doi: 10.1001/jama.2016.18189. Erratum in: JAMA. 2017 Feb 14;317(6):648.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult, immunocompetent men and women in good health of any ethnic group
  • Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
  • History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months

Exclusion Criteria:

  • Present episode of genital herpes at time of randomization
  • Clinically relevant acute or chronic infections (excluding HSV-2)
  • Known intolerance to valacyclovir, acyclovir, or any component of the formulation
  • Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
AiCuris Anti-infective Cures GmbH
AiCuris Anti-infective Cures GmbH
Medpace, Inc.
Not Provided
AiCuris Anti-infective Cures GmbH
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP