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

This study has been terminated.
Medpace, Inc.
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH Identifier:
First received: August 3, 2012
Last updated: September 21, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Genital Herpes
Drug: AIC316
Drug: Valacyclovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by AiCuris Anti-infective Cures GmbH:

Primary Outcome Measures:
  • 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 ]

Enrollment: 91
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIC316
100 mg once daily for 28 days
Drug: AIC316
oral administration
Active Comparator: Valacyclovir
500 mg once daily for 28 days
Drug: Valacyclovir
oral administration


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01658826

United States, Indiana
Indiana University School of Medicine, IU Infectious Diseases Research
Indianapolis, Indiana, United States, 46202
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Texas
University of Texas Health Science Centre, Center for Clincial Studies
Houston, Texas, United States, 77030
United States, Washington
University of Washington, Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
AiCuris Anti-infective Cures GmbH
Medpace, Inc.
  More Information

Responsible Party: AiCuris Anti-infective Cures GmbH Identifier: NCT01658826     History of Changes
Other Study ID Numbers: AIC316-01-II-02 
Study First Received: August 3, 2012
Last Updated: September 21, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by AiCuris Anti-infective Cures GmbH:
Viral shedding

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Antiviral Agents
Anti-Infective Agents processed this record on October 25, 2016