Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
This study has been terminated.
Sponsor:
AiCuris GmbH & Co.KG
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
AiCuris GmbH & Co.KG
ClinicalTrials.gov Identifier:
NCT01658826
First received: August 3, 2012
Last updated: July 8, 2014
Last verified: August 2012
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Purpose
The aim of the study is to evaluate the safety and efficacy of AIC316 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.
| Condition | Intervention | Phase |
|---|---|---|
|
Genital Herpes |
Drug: AIC316 Drug: Valacyclovir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of AIC316 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults. |
Resource links provided by NLM:
Further study details as provided by AiCuris GmbH & Co.KG:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 91 |
| Study Start Date: | October 2012 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658826
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658826
Locations
| 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 | |
Sponsors and Collaborators
AiCuris GmbH & Co.KG
Medpace, Inc.
More Information
No publications provided
| Responsible Party: | AiCuris GmbH & Co.KG |
| ClinicalTrials.gov Identifier: | NCT01658826 History of Changes |
| Other Study ID Numbers: | AIC316-01-II-02 |
| Study First Received: | August 3, 2012 |
| Last Updated: | July 8, 2014 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by AiCuris GmbH & Co.KG:
|
AIC316 Viral shedding |
Additional relevant MeSH terms:
|
Herpes Genitalis DNA Virus Infections Genital Diseases, Female Genital Diseases, Male Herpes Simplex Herpesviridae Infections Sexually Transmitted Diseases |
Sexually Transmitted Diseases, Viral Virus Diseases Valacyclovir Anti-Infective Agents Antiviral Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015