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

NCT ID: NCT01658826

Last Updated: 2023-04-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Genital Herpes

Keywords

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AIC316 Viral shedding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

AIC316

Intervention Type DRUG

100 mg oral administration

Valacyclovir

Intervention Type DRUG

500 mg oral administration

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.

Group Type ACTIVE_COMPARATOR

AIC316

Intervention Type DRUG

100 mg oral administration

Valacyclovir

Intervention Type DRUG

500 mg oral administration

Interventions

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AIC316

100 mg oral administration

Intervention Type DRUG

Valacyclovir

500 mg oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

AiCuris Anti-infective Cures AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Indiana University School of Medicine, IU Infectious Diseases Research

Indianapolis, Indiana, United States

Site Status

Westover Heights Clinic

Portland, Oregon, United States

Site Status

University of Texas Health Science Centre, Center for Clincial Studies

Houston, Texas, United States

Site Status

University of Washington, Virology Research Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27997653 (View on PubMed)

Other Identifiers

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AIC316-01-II-02

Identifier Type: -

Identifier Source: org_study_id