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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:
FHI 360
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH

Tracking Information
First Submitted Date  ICMJE January 12, 2010
First Posted Date  ICMJE January 13, 2010
Last Update Posted Date July 27, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2010)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HSV-2
Intervention  ICMJE
  • Drug: AIC316
    Oral administration
  • Drug: Placebo
    Oral administration
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2011)		 156
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2010)		 150
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01047540
Other Study ID Numbers  ICMJE AIC316-01-II-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AiCuris Anti-infective Cures GmbH
Study Sponsor  ICMJE AiCuris Anti-infective Cures GmbH
Collaborators  ICMJE FHI 360
Investigators  ICMJE Not Provided
PRS Account AiCuris Anti-infective Cures GmbH
Verification Date October 2010

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