Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.

The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Study Overview

• Status: Terminated
• Conditions: Genital Herpes
• Intervention / Treatment: Drug: AIC316; Drug: Valacyclovir

Detailed Description

Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine, IU Infectious Diseases 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
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington, Virology Research Clinic

Participation Criteria

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
• Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
• History of recurrent episodes (>=4 to <=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day.

Exclusion Criteria:

• Present episode of genital herpes at time of randomization
• Clinically relevant acute or chronic infections (excluding HSV-2)
• Known intolerance to valacyclovir, acyclovir, or any component of the formulation
• Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIC316, Then Valacyclovir; Participants first received AIC316 100 mg once daily for 28 days. After a washout period of 28 days, they then received Valacyclovir 500 mg once daily for 28 days.	Drug: AIC316; 100 mg oral administration; Drug: Valacyclovir; 500 mg oral administration
Active Comparator: Valacyclovir, Then AIC316; Participants first received Valacyclovir 500 mg once daily for 28 days. After a washout period of 28 days, they then received AIC316 100 mg once daily for 28 days.	Drug: AIC316; 100 mg oral administration; Drug: Valacyclovir; 500 mg oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-subject Genital HSV Mucocutaneous Shedding Rate	Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate.	28 days
Overall Shedding Rate	Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group.	28 days

Collaborators and Investigators

• Sponsor: AiCuris Anti-infective Cures AG
• Collaborators: Medpace, Inc.

Publications and helpful links

General Publications

• Wald A, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Fife K, Selke S, Huang ML, Stobernack HP, Zimmermann H, Corey L, Birkmann A, Ruebsamen-Schaeff H. Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences: A Randomized Clinical Trial. JAMA. 2016 Dec 20;316(23):2495-2503. doi: 10.1001/jama.2016.18189. Erratum In: JAMA. 2017 Feb 14;317(6):648.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 7, 2012

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

• Keywords: AIC316; Viral shedding
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Valacyclovir; Pritelivir
• Other Study ID Numbers: AIC316-01-II-02