Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2
NCT ID: NCT01047540
Last Updated: 2023-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2010-03-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dose regimen 1
AIC316
Oral administration
Dose regimen 2
AIC316
Oral administration
Dose regimen 3
AIC316
Oral administration
Dose regimen 4
AIC316
Oral administration
Placebo
Placebo
Oral administration
Interventions
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AIC316
Oral administration
AIC316
Oral administration
AIC316
Oral administration
AIC316
Oral administration
Placebo
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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FHI 360
OTHER
AiCuris Anti-infective Cures AG
INDUSTRY
Responsible Party
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Locations
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Cetero Research Miami Gardens
Miami, Florida, United States
Indiana University School of Medicine, Office for Research
Indianapolis, Indiana, United States
Westover Heights Clinic
Portland, Oregon, United States
University of Texas Health Science Centre, Center for Clincial Studies
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington, Virology Research Clinic
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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AIC316-01-II-01
Identifier Type: -
Identifier Source: org_study_id
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