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

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	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; 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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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