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 Anti-infective Cures GmbH

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

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

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

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

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