Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
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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
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Sponsor:
AiCuris Anti-infective Cures GmbH
Collaborator:
FHI 360
Information provided by (Responsible Party):
AiCuris Anti-infective Cures GmbH
Tracking Information | |||
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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 |
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 |
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Condition ICMJE | HSV-2 | ||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
156 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |