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.
1 other identifier
interventional
91
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2012
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
April 21, 2023
CompletedApril 21, 2023
April 1, 2023
7 months
August 3, 2012
January 6, 2022
April 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
AIC316, Then Valacyclovir
EXPERIMENTALParticipants 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.
Valacyclovir, Then AIC316
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AiCuris Anti-infective Cures AGlead
- Medpace, Inc.collaborator
Study Sites (4)
Indiana University School of Medicine, IU Infectious Diseases Research
Indianapolis, Indiana, 46202, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
University of Texas Health Science Centre, Center for Clincial Studies
Houston, Texas, 77030, United States
University of Washington, Virology Research Clinic
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 27997653DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Information Desk
- Organization
- AiCuris Anti-infective Cures GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 7, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
April 21, 2023
Results First Posted
April 21, 2023
Record last verified: 2023-04