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

• Sponsor: AiCuris Anti-infective Cures AG (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01658826
• Collaborator: Medpace, Inc. (Industry)
• Enrollment: 91
• Locations: 4
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 22.8
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Genital Herpes	Drug: AIC316; Drug: Valacyclovir	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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 Start Date: Oct 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIC316 100 mg once daily for 28 days	Drug: AIC316; oral administration
Active Comparator: Valacyclovir 500 mg once daily for 28 days	Drug: Valacyclovir; oral administration

Outcome Measures

Primary Outcome Measures

1. Within-subject genital HSV mucocutaneous shedding rate: number of HSV positive swabs per subject relative to the total number of swabs collected per subject. [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University School of Medicine, IU Infectious Diseases Research	Indianapolis	Indiana	United States	46202
2	Westover Heights Clinic	Portland	Oregon	United States	97210
3	University of Texas Health Science Centre, Center for Clincial Studies	Houston	Texas	United States	77030
4	University of Washington, Virology Research Clinic	Seattle	Washington	United States	98104

Sponsors and Collaborators

• AiCuris Anti-infective Cures AG
• Medpace, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AiCuris Anti-infective Cures AG
• ClinicalTrials.gov Identifier: NCT01658826
• Other Study ID Numbers: AIC316-01-II-02
• First Posted: Aug 7, 2012
• Last Update Posted: Sep 23, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by AiCuris Anti-infective Cures AG: AIC316; Viral shedding
• Additional relevant MeSH terms: Herpes Genitalis; Valacyclovir; Pritelivir

Study Results

No Results Posted as of Sep 23, 2016