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

This study has been terminated.
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01658826
First received: August 3, 2012
Last updated: August 13, 2013
Last verified: August 2012

August 3, 2012
August 13, 2013
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01658826 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 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 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
91
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01658826
AIC316-01-II-02
No
AiCuris GmbH & Co.KG
AiCuris GmbH & Co.KG
Medpace, Inc.
Not Provided
AiCuris GmbH & Co.KG
August 2012

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