Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
- Registration Number
- NCT01658826
- Lead Sponsor
- AiCuris Anti-infective Cures AG
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 91
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AIC316, Then Valacyclovir AIC316 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. Valacyclovir, Then AIC316 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. AIC316, Then Valacyclovir 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. Valacyclovir, Then AIC316 Valacyclovir 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.
- Primary Outcome Measures
Name Time Method Within-subject Genital HSV Mucocutaneous Shedding Rate 28 days Subjects were assessed for within-subject genital HSV mucocutaneous shedding rate, as calculated by the number of HSV-positive swabs per subject relative to the total number of swabs collected per subject. The swab test detects the presence of herpes virus DNA. A swab was regarded as positive for HSV-DNA if at least 3 HSV genome copies were detected by quantitative PCR per reaction (equaling 150 copies per mL of swab collection medium). When multiple swabs were available from the same time point (e.g., genital and lesional swab), the swab with the highest copy number was retained for computation of the shedding rate.
Overall Shedding Rate 28 days Subjects were assessed for overall shedding rate as the total number of HSV-positive swabs per treatment group divided by the number of swabs collected per treatment group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Texas Health Science Centre, Center for Clincial Studies
🇺🇸Houston, Texas, United States
University of Washington, Virology Research Clinic
🇺🇸Seattle, Washington, United States
Indiana University School of Medicine, IU Infectious Diseases Research
🇺🇸Indianapolis, Indiana, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States