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

AiCuris Anti-infective Cures AG156 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

156

Conditions

HSV-2

Interventions

AIC316DRUG

Oral administration

AIC316DRUG

Oral administration

AIC316DRUG

Oral administration

AIC316DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

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

Outcomes

Primary Outcomes

Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)

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.

Time frame: 28 days

Data from ClinicalTrials.gov

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