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

Completed · Phase 2 · Has a placebo group

Conditions studied: HSV-2

In brief

The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes

Key facts

Study ID: NCT01047540
Run by: AiCuris Anti-infective Cures AG
People needed: 156
Starts: 2010-03-01
Expected to finish: 2011-03-01
Last updated by the study team: 2023-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

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

Full record on ClinicalTrials.gov

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