Back to resultsSafety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Primary Purpose
Genital Herpes
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AIC316
Valacyclovir
Sponsored by
About this trial
This is an interventional prevention trial for Genital Herpes focused on measuring AIC316, Viral shedding
Eligibility Criteria
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
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
Sites / Locations
- Indiana University School of Medicine, IU Infectious Diseases Research
- Westover Heights Clinic
- University of Texas Health Science Centre, Center for Clincial Studies
- University of Washington, Virology Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AIC316, Then Valacyclovir
Valacyclovir, Then AIC316
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01658826
First Posted
August 3, 2012
Last Updated
April 14, 2023
Sponsor
AiCuris Anti-infective Cures AG
Collaborators
Medpace, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01658826
Brief Title
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AiCuris Anti-infective Cures AG
Collaborators
Medpace, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes
Keywords
AIC316, Viral shedding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIC316, Then Valacyclovir
Arm Type
Experimental
Arm Description
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.
Arm Title
Valacyclovir, Then AIC316
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AIC316
Intervention Description
100 mg oral administration
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Intervention Description
500 mg oral administration
Primary Outcome Measure Information:
Title
Within-subject Genital HSV Mucocutaneous Shedding Rate
Description
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.
Time Frame
28 days
Title
Overall Shedding Rate
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Indiana University School of Medicine, IU Infectious Diseases Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Texas Health Science Centre, Center for Clincial Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington, Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27997653
Citation
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.
Results Reference
derived
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Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
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