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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2010
Last Updated Date	July 20, 2012
Start Date ^ICMJE	March 2010
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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01047540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	HSV-2
Intervention ^ICMJE	Drug: AIC316 Oral administration Drug: Placebo Oral administration
Study Arm (s)	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
Enrollment ^ICMJE	156
Completion Date	March 2011
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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	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
Responsible Party	AiCuris GmbH & Co.KG
Study Sponsor ^ICMJE	AiCuris GmbH & Co.KG
Collaborators ^ICMJE	FHI 360
Investigators ^ICMJE	Not Provided
Information Provided By	AiCuris GmbH & Co.KG
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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