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

Genital Herpes Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01658826
• Other study ID #: AIC316-01-II-02
• Status: Terminated
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2023
• Source: AiCuris Anti-infective Cures AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• AIC316
100 mg oral administration
• Valacyclovir
500 mg oral administration

Locations

Country	Name	City	State
United States	University of Texas Health Science Centre, Center for Clincial Studies	Houston	Texas
United States	Indiana University School of Medicine, IU Infectious Diseases Research	Indianapolis	Indiana
United States	Westover Heights Clinic	Portland	Oregon
United States	University of Washington, Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AiCuris Anti-infective Cures AG	Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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