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

This study has suspended participant recruitment.
(Clinical hold due to findings in nonclinical studies)
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01658826
First received: August 3, 2012
Last updated: May 14, 2013
Last verified: August 2012
History of Changes
  Purpose

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.


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 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes
U.S. FDA Resources

Further study details as provided by AiCuris GmbH & Co.KG:

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 ]

Estimated Enrollment: 90
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658826

Locations
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 GmbH & Co.KG
Medpace, Inc.
  More Information

No publications provided

Responsible Party: AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier: NCT01658826     History of Changes
Other Study ID Numbers: AIC316-01-II-02
Study First Received: August 3, 2012
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by AiCuris GmbH & Co.KG:
AIC316
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
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013