Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
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ClinicalTrials.gov Identifier: NCT01658826 |
Recruitment Status
:
Terminated
First Posted
: August 7, 2012
Last Update Posted
: September 23, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Genital Herpes | Drug: AIC316 Drug: Valacyclovir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 2012 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | July 2013 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658826
United States, Indiana | |
Indiana University School of Medicine, IU Infectious Diseases Research | |
Indianapolis, Indiana, United States, 46202 | |
United States, Oregon | |
Westover Heights Clinic | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
University of Texas Health Science Centre, Center for Clincial Studies | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
University of Washington, Virology Research Clinic | |
Seattle, Washington, United States, 98104 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AiCuris Anti-infective Cures GmbH |
ClinicalTrials.gov Identifier: | NCT01658826 History of Changes |
Other Study ID Numbers: |
AIC316-01-II-02 |
First Posted: | August 7, 2012 Key Record Dates |
Last Update Posted: | September 23, 2016 |
Last Verified: | September 2016 |
Keywords provided by AiCuris Anti-infective Cures GmbH:
AIC316 Viral shedding |
Additional relevant MeSH terms:
Herpes Genitalis Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Genital Diseases, Male Genital Diseases, Female Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents |