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

January 12, 2010
July 20, 2012
March 2010
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01047540 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HSV-2
  • Drug: AIC316
    Oral administration
  • Drug: Placebo
    Oral administration
  • Experimental: Dose regimen 1
    Intervention: Drug: AIC316
  • Experimental: Dose regimen 2
    Intervention: Drug: AIC316
  • Experimental: Dose regimen 3
    Intervention: Drug: AIC316
  • Experimental: Dose regimen 4
    Intervention: Drug: AIC316
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Wald A, Corey L, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Kriesel J, Fife K, Galitz L, Stoelben S, Huang ML, Selke S, Stobernack HP, Ruebsamen-Schaeff H, Birkmann A. Helicase-primase inhibitor pritelivir for HSV-2 infection. N Engl J Med. 2014 Jan 16;370(3):201-10. doi: 10.1056/NEJMoa1301150.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
March 2011
December 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01047540
AIC316-01-II-01
No
AiCuris GmbH & Co.KG
AiCuris GmbH & Co.KG
FHI 360
Not Provided
AiCuris GmbH & Co.KG
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP