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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
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Genital Herpes Drug: AIC316 Drug: Valacyclovir Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Anti-infective Cures GmbH
Medpace, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AiCuris Anti-infective Cures GmbH
ClinicalTrials.gov Identifier: NCT01658826     History of Changes
Other Study ID Numbers: AIC316-01-II-02
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by AiCuris Anti-infective Cures GmbH:
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