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

This study has been completed.
Sponsor:
Collaborator:
FHI 360
Information provided by (Responsible Party):
AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01047540
First received: January 12, 2010
Last updated: July 20, 2012
Last verified: October 2010
  Purpose

The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes


Condition Intervention Phase
HSV-2
Drug: AIC316
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • 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
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 ClinicalTrials.gov identifier: 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 GmbH & Co.KG
FHI 360
  More Information

No publications provided by AiCuris GmbH & Co.KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier: NCT01047540     History of Changes
Other Study ID Numbers: AIC316-01-II-01
Study First Received: January 12, 2010
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014