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Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01047540
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : July 27, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes

Condition or disease Intervention/treatment Phase
HSV-2 Drug: AIC316 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection
Study Start Date : March 2010
Primary Completion Date : December 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Dose regimen 1 Drug: AIC316
Oral administration
Experimental: Dose regimen 2 Drug: AIC316
Oral administration
Experimental: Dose regimen 3 Drug: AIC316
Oral administration
Experimental: Dose regimen 4 Drug: AIC316
Oral administration
Placebo Comparator: Placebo Drug: Placebo
Oral administration


Outcome Measures

Primary Outcome Measures :
  1. Compare the efficacy of 4 different doses of AIC316 and matching placebo with respect to the suppression of herpes simplex virus replication [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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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
  • History of recurrent episodes of genital herpes for at least 12 months
  • Seropositive for Herpes Simplex Virus HSV Type 2
  • Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

  • Present episode of genital herpes
  • Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
  • Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
  • Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
Contacts and Locations

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): NCT01047540


Locations
United States, Florida
Cetero Research Miami Gardens
Miami, Florida, United States, 33169
United States, Indiana
Indiana University School of Medicine, Office for 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, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
University of Washington, Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
AiCuris Anti-infective Cures GmbH
FHI 360
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AiCuris Anti-infective Cures GmbH
ClinicalTrials.gov Identifier: NCT01047540     History of Changes
Other Study ID Numbers: AIC316-01-II-01
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: October 2010

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents