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

April 14, 2023 updated by: AiCuris Anti-infective Cures AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33169
        • Cetero Research Miami Gardens
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine, Office for Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Centre, Center for Clincial Studies
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington, Virology Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral administration
Experimental: Dose regimen 1
Drug: AIC316
Oral administration
Other Names:
  • pritelivir
Experimental: Dose regimen 2
Drug: AIC316
Oral administration
Other Names:
  • pritelivir
Experimental: Dose regimen 3
Drug: AIC316
Oral administration
Other Names:
  • pritelivir
Experimental: Dose regimen 4
Drug: AIC316
Oral administration
Other Names:
  • pritelivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate)
Time Frame: 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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AiCuris Anti-infective Cures AG

Collaborators

FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIC316-01-II-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HSV-2

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe