Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- AiCuris Anti-infective Cures AG
- Study ID
- NCT01658826
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Genital Herpes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AIC316 — DRUG100 mg oral administration
- Valacyclovir — DRUG500 mg oral administration
Study Details
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.
Key Dates
- Start date
- Oct 31, 2012
- Status verified
- Apr 2023
- Primary completion
- May 31, 2013
- Completion
- Jul 31, 2013
Study Design
- Enrollment
- 91 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- PREVENTION
Arms
- Experimental: AIC316, Then ValacyclovirParticipants 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.
- Active Comparator: Valacyclovir, Then AIC316Participants 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.
Primary Outcome Measure
Within-subject Genital HSV Mucocutaneous Shedding Rate [ Time Frame: 28 days ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University School of Medicine, IU Infectious Diseases Research | Indianapolis | Indiana | 46202 | - |
| Westover Heights Clinic | Portland | Oregon | 97210 | - |
| University of Texas Health Science Centre, Center for Clincial Studies | Houston | Texas | 77030 | - |
| University of Washington, Virology Research Clinic | Seattle | Washington | 98104 | - |