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

Phase 2

Completed

• Conditions: HSV-2
• Interventions: Drug: AIC316; Drug: Placebo

• Registration Number: NCT01047540
• Lead Sponsor: AiCuris Anti-infective Cures AG

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 available

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Study Start: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Disposition First Submitted: 2012-01-18
• Disposition First Submitted QC: 2012-07-20
• Disposition First Posted: 2012-07-27
• Results First Submitted: 2022-01-06
• Results First Submitted QC: 2022-01-06
• Results First Posted: 2022-02-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose regimen 3	AIC316	-
Dose regimen 1	AIC316	-
Dose regimen 2	AIC316	-
Dose regimen 4	AIC316	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)	28 days	Subjects were assessed for shedding rate as the percentage of number of swab days with at least one swab positive for HSV DNA relative to the total number of days with analyzable swabs. Measurement was based on presence of HSV DNA measured on the material collected from swabs taken at the visits by the investigator and daily swabbing of the anogenital region by the patient during the treatment and post-treatment period.

Trial Locations

Locations (6)

University of Washington, Virology Research Clinic; 🇺🇸 Seattle, Washington, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Indiana University School of Medicine, Office for Research; 🇺🇸 Indianapolis, Indiana, United States

Cetero Research Miami Gardens; 🇺🇸 Miami, Florida, United States

Westover Heights Clinic; 🇺🇸 Portland, Oregon, United States

University of Texas Health Science Centre, Center for Clincial Studies; 🇺🇸 Houston, Texas, United States